Country/Region,Site Number,Sites,Subjects,Subject Status,Visits,Pages,Queries (Op/Ans/SDV),RecordPosition,Field,Query Group,QueryID(ReQry),QueryStatus,Opened By,Opened Date,Answered By,Answered Date,Closed By,Closed Date,DaysNotYetClosed,Days to Answer,Days to Close,QueryText,Answer Text (if any),StudyParameter,SiteGroupParameter,SiteNumberParameter,SiteParameter,SubjectParameter,SubjectStatusParameter,FolderParameter,FormParameter,FieldParameter,MarkingGroupParameter,QueryStatusParameter,IncludeInactivePagesParameter,PageSDVParameter,PageFrozenParameter,PageLockedParameter,StartDateParameter,EndDateParameter,MilestoneParameter,ReportTypeParameter,VersionNumber,PrintDateTime,TimeZone,RunUser,ErrorString,OpenedDateSrtble,AnsweredDateSrtble,ClosedDateSrtble,VisitSiteLevel,VisitCountryLevel,VisitStudyLevel,PageSubjectLevel,PageSiteLevel,PageCountryLevel,PageStudyLevel
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15263510,Closed,systemuser,10 Aug 2025 18:13:22:080,systemuser,10 Aug 2025 18:14:02:703,systemuser,10 Aug 2025 18:14:02:703,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:13:22.080,20250810 18:14:02.703,20250810 18:14:02.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260224 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18823240,Closed,systemuser,09 Feb 2026 08:04:37:693,systemuser,24 Feb 2026 07:13:51:017,systemuser,24 Feb 2026 07:13:51:140,,15,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:04:37.693,20260224 07:13:51.017,20260224 07:13:51.140,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933269,Closed,systemuser,20 May 2026 12:06:05:857,,,systemuser,20 May 2026 12:06:28:613,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:06:05.857,,20260520 12:06:28.613,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16456121,Closed,systemuser,17 Oct 2025 09:46:14:623,,,systemuser,20 Oct 2025 07:47:36:470,,,3,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:46:14.623,,20251020 07:47:36.470,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,16431760,Closed,SanchariDutta@025,16 Oct 2025 06:15:51:413,BrezVe1,20 Oct 2025 08:56:17:217,SanchariDutta@025,26 Nov 2025 06:23:57:113,,4,37,"ECG: In vendor file, ECG data present for Screening visit of 08-Aug-2025 with EGREFID 143807412. However another collection date is recorded for 19-Aug-2025 with EGREFID 144307755 for Screening visit only. Please check and confirm for the Screening visit ECG was collected twice, if yes kindly provide the reason. Else clarify.",retest done on 19Aug2025 - hypertension,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:15:51.413,20251020 08:56:17.217,20251126 06:23:57.113,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17300080 (16431760),Closed,SanchariDutta@025,26 Nov 2025 06:23:57:173,gnovotna@email.cz2,28 Nov 2025 10:36:55:197,SanchariDutta@025,01 Dec 2025 06:43:56:800,,2,3,"RQ-ECG1: Thank you for your response. As confirmed, retest was done for ECG on the 19-Aug-2025 in the Screening visit due to hypertension hence kindly add the details for ECG collection of 19-Aug-2025 in the Comments form present in the Screening to end of study folder.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251126 06:23:57.173,20251128 10:36:55.197,20251201 06:43:56.800,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,15263437,Closed,systemuser,10 Aug 2025 17:49:04:123,systemuser,10 Aug 2025 17:50:30:437,systemuser,10 Aug 2025 17:50:30:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.123,20250810 17:50:30.437,20250810 17:50:30.440,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,15263438,Closed,systemuser,10 Aug 2025 17:49:04:130,systemuser,10 Aug 2025 17:50:30:440,systemuser,10 Aug 2025 17:50:30:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.130,20250810 17:50:30.440,20250810 17:50:30.440,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,15263439,Closed,systemuser,10 Aug 2025 17:49:04:137,systemuser,10 Aug 2025 17:50:30:440,systemuser,10 Aug 2025 17:50:30:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.137,20250810 17:50:30.440,20250810 17:50:30.440,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,15263440,Closed,systemuser,10 Aug 2025 17:49:04:143,systemuser,10 Aug 2025 17:50:30:440,systemuser,10 Aug 2025 17:50:30:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.143,20250810 17:50:30.440,20250810 17:50:30.440,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,15263441,Closed,systemuser,10 Aug 2025 17:49:04:150,systemuser,10 Aug 2025 17:50:30:440,systemuser,10 Aug 2025 17:50:30:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.150,20250810 17:50:30.440,20250810 17:50:30.440,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Collection Time,Auto,15263436,Closed,systemuser,10 Aug 2025 17:49:04:117,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.117,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,15263442,Closed,systemuser,10 Aug 2025 17:49:04:160,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.160,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,15263444,Closed,systemuser,10 Aug 2025 17:49:04:173,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.173,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,15263443,Closed,systemuser,10 Aug 2025 17:49:04:170,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.170,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,15263445,Closed,systemuser,10 Aug 2025 17:49:04:180,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.180,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,15263435,Closed,systemuser,10 Aug 2025 17:49:04:103,systemuser,10 Aug 2025 17:50:30:467,systemuser,10 Aug 2025 17:50:30:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:49:04.103,20250810 17:50:30.467,20250810 17:50:30.467,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Neurologic Examination,0/0/N,5,Are there any findings?,Auto,15905765,Closed,systemuser,10 Sep 2025 17:03:52:293,systemuser,22 Sep 2025 07:37:28:777,systemuser,22 Sep 2025 07:37:28:780,,12,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 17:03:52.293,20250922 07:37:28.777,20250922 07:37:28.780,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Lifetime Manic Episode,Auto,15263451,Closed,systemuser,10 Aug 2025 18:00:44:093,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.093,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Lifetime Hypomanic Episode ,Auto,15263452,Closed,systemuser,10 Aug 2025 18:00:44:100,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.100,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,History of Primary psychotic or psychotic depression symptoms (except during past mood episodes),Auto,15263453,Closed,systemuser,10 Aug 2025 18:00:44:110,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.110,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Moderate to severe Alcohol Use Disorder in past 6 months,Auto,15263454,Closed,systemuser,10 Aug 2025 18:00:44:120,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.120,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Moderate to severe Substance Use Disorder (other than nicotine) in past 6 months,Auto,15263455,Closed,systemuser,10 Aug 2025 18:00:44:127,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.127,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Obsessive-Compulsive Disorder in past year,Auto,15263456,Closed,systemuser,10 Aug 2025 18:00:44:133,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.133,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,PTSD in past year,Auto,15263457,Closed,systemuser,10 Aug 2025 18:00:44:140,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:703,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.140,20250811 09:56:13.703,20250811 09:56:13.703,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Anorexia Nervosa in past year,Auto,15263458,Closed,systemuser,10 Aug 2025 18:00:44:147,systemuser,11 Aug 2025 09:56:13:703,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.147,20250811 09:56:13.703,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Bulimia Nervosa in past year,Auto,15263459,Closed,systemuser,10 Aug 2025 18:00:44:153,systemuser,11 Aug 2025 09:56:13:707,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.153,20250811 09:56:13.707,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Panic Disorder past 2 years that was focus of tx,Auto,15263460,Closed,systemuser,10 Aug 2025 18:00:44:163,systemuser,11 Aug 2025 09:56:13:707,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.163,20250811 09:56:13.707,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Generalized Anxiety Disorder past 2 years that was focus of tx,Auto,15263461,Closed,systemuser,10 Aug 2025 18:00:44:173,systemuser,11 Aug 2025 09:56:13:707,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.173,20250811 09:56:13.707,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Social Anxiety Disorder past 2 years that was focus of tx,Auto,15263462,Closed,systemuser,10 Aug 2025 18:00:44:180,systemuser,11 Aug 2025 09:56:13:707,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.180,20250811 09:56:13.707,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Specific Phobia past 2 years that was focus of tx,Auto,15263463,Closed,systemuser,10 Aug 2025 18:00:44:187,systemuser,11 Aug 2025 09:56:13:707,systemuser,11 Aug 2025 09:56:13:707,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.187,20250811 09:56:13.707,20250811 09:56:13.707,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Symptoms of insomnia in the MDD criteria,Auto,15263450,Closed,systemuser,10 Aug 2025 18:00:44:087,systemuser,10 Aug 2025 18:01:03:923,systemuser,10 Aug 2025 18:01:03:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.087,20250810 18:01:03.923,20250810 18:01:03.927,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Current MDE,Auto,15263449,Closed,systemuser,10 Aug 2025 18:00:44:073,systemuser,10 Aug 2025 18:01:03:927,systemuser,10 Aug 2025 18:01:03:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 18:00:44.073,20250810 18:01:03.927,20250810 18:01:03.927,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Body Mass Index,Auto,15263433,Closed,systemuser,10 Aug 2025 17:46:10:080,systemuser,10 Aug 2025 17:47:40:230,systemuser,10 Aug 2025 17:47:40:230,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:46:10.080,20250810 17:47:40.230,20250810 17:47:40.230,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,15263432,Closed,systemuser,10 Aug 2025 17:46:10:053,systemuser,10 Aug 2025 17:47:54:423,systemuser,10 Aug 2025 17:47:54:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 17:46:10.053,20250810 17:47:54.423,20250810 17:47:54.427,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,15787176,Closed,systemuser,03 Sep 2025 14:15:49:967,systemuser,10 Sep 2025 16:48:15:237,systemuser,10 Sep 2025 16:48:15:240,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250903 14:15:49.967,20250910 16:48:15.237,20250910 16:48:15.240,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/V,1,Start Date,Auto,18369265,Closed,systemuser,09 Jan 2026 09:18:24:037,BrezVe1,26 Jan 2026 07:30:33:603,systemuser,02 Feb 2026 15:49:39:993,,17,7,Please enter study drug administration start date as soon as it's available,will be done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260109 09:18:24.037,20260126 07:30:33.603,20260202 15:49:39.993,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Number of tablets taken,Auto,15905547,Closed,systemuser,10 Sep 2025 16:46:44:563,systemuser,10 Sep 2025 16:49:08:590,systemuser,10 Sep 2025 16:49:08:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:46:44.563,20250910 16:49:08.590,20250910 16:49:08.590,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,15831041,Closed,systemuser,05 Sep 2025 08:23:40:477,,,systemuser,10 Sep 2025 16:46:43:877,,,5,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:23:40.477,,20250910 16:46:43.877,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,17788857,Closed,Juhita@ksha4,09 Dec 2025 11:48:49:347,BrezVe1,15 Dec 2025 08:45:11:810,Ashwini201,16 Dec 2025 10:48:29:370,,6,1,DM: Kindly update the end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 11:48:49.347,20251215 08:45:11.810,20251216 10:48:29.370,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,18018621 (17788857),Closed,Ashwini201,16 Dec 2025 10:48:29:537,BrezVe1,22 Dec 2025 10:50:22:210,shyamaprasad972,23 Dec 2025 07:56:58:290,,6,1,"RQ-DM1: Please enter end date for Study Drug during Induction Phase. Per CCGs, as first dose of Stabilization Phase SDA is entered as 14-Nov-2025, End Date for Induction Study Drug should be one day prior if subject did not have any missed doses. Please review and clarify/update.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251216 10:48:29.537,20251222 10:50:22.210,20251223 07:56:58.290,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,16456120,Closed,systemuser,17 Oct 2025 09:46:14:593,,,systemuser,20 Oct 2025 06:26:36:430,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:46:14.593,,20251020 06:26:36.430,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,End Date,DM,19612278,Closed,Juhita@ksha4,20 Mar 2026 07:16:42:790,BrezVe1,23 Mar 2026 13:18:41:113,Juhita@ksha4,25 Mar 2026 15:24:59:077,,3,2,Medical Review I-3085477: Please provide end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260320 07:16:42.790,20260323 13:18:41.113,20260325 15:24:59.077,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,17002734,Closed,systemuser,14 Nov 2025 07:48:41:920,BrezVe1,18 Nov 2025 09:13:35:153,Ashwini201,03 Dec 2025 12:23:16:810,,4,15,Please enter study drug administration start date as soon as it's available,will be done asap,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 07:48:41.920,20251118 09:13:35.153,20251203 12:23:16.810,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,DM,17543078,Closed,Ashwini201,03 Dec 2025 12:23:46:027,BrezVe1,15 Dec 2025 08:45:07:100,Ashwini201,15 Dec 2025 14:25:45:130,,12,0,RQ-DM1: Thank you for the response. Please verify and update the data once available.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251203 12:23:46.027,20251215 08:45:07.100,20251215 14:25:45.130,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,DM,17995921 (17543078),Closed,Ashwini201,15 Dec 2025 14:25:45:323,BrezVe1,22 Dec 2025 10:50:05:273,shyamaprasad972,23 Dec 2025 08:02:26:950,,7,1,"RQ-DM2: Subject meet the evaluation repose at 1.5 visit so kindly update the start date as 14-Nov-2025, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 14:25:45.323,20251222 10:50:05.273,20251223 08:02:26.950,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16728273,Closed,systemuser,03 Nov 2025 07:49:01:390,systemuser,03 Nov 2025 07:49:17:360,systemuser,03 Nov 2025 07:49:17:360,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 07:49:01.390,20251103 07:49:17.360,20251103 07:49:17.360,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 1.5 Induction (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17189582,Closed,systemuser,21 Nov 2025 11:21:32:253,systemuser,24 Nov 2025 08:21:37:273,systemuser,24 Nov 2025 08:21:37:273,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251121 11:21:32.253,20251124 08:21:37.273,20251124 08:21:37.273,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17189564,Closed,systemuser,21 Nov 2025 11:20:47:400,systemuser,21 Nov 2025 11:20:54:560,systemuser,21 Nov 2025 11:20:54:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251121 11:20:47.400,20251121 11:20:54.560,20251121 11:20:54.563,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.2 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,17951601,Closed,systemuser,12 Dec 2025 08:52:46:550,systemuser,12 Dec 2025 08:52:56:350,systemuser,12 Dec 2025 08:52:56:353,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251212 08:52:46.550,20251212 08:52:56.350,20251212 08:52:56.353,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17984649,Closed,systemuser,15 Dec 2025 08:23:50:930,systemuser,15 Dec 2025 08:23:56:007,systemuser,15 Dec 2025 08:23:56:007,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 08:23:50.930,20251215 08:23:56.007,20251215 08:23:56.007,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,18237831,Closed,systemuser,29 Dec 2025 12:48:05:070,systemuser,29 Dec 2025 12:49:20:210,systemuser,29 Dec 2025 12:49:20:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 12:48:05.070,20251229 12:49:20.210,20251229 12:49:20.213,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,18237829,Closed,systemuser,29 Dec 2025 12:48:05:050,systemuser,29 Dec 2025 12:49:20:227,systemuser,29 Dec 2025 12:49:20:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 12:48:05.050,20251229 12:49:20.227,20251229 12:49:20.227,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,18237830,Closed,systemuser,29 Dec 2025 12:48:05:063,systemuser,29 Dec 2025 12:49:20:227,systemuser,29 Dec 2025 12:49:20:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 12:48:05.063,20251229 12:49:20.227,20251229 12:49:20.227,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18401903,Closed,systemuser,12 Jan 2026 17:14:06:993,systemuser,12 Jan 2026 17:14:19:247,systemuser,12 Jan 2026 17:14:19:247,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260112 17:14:06.993,20260112 17:14:19.247,20260112 17:14:19.247,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,15905010,Closed,systemuser,10 Sep 2025 16:16:14:407,systemuser,10 Sep 2025 16:16:53:590,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.407,20250910 16:16:53.590,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,15905011,Closed,systemuser,10 Sep 2025 16:16:14:420,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.420,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,15905012,Closed,systemuser,10 Sep 2025 16:16:14:490,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.490,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,15905013,Closed,systemuser,10 Sep 2025 16:16:14:513,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.513,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,15905014,Closed,systemuser,10 Sep 2025 16:16:14:527,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.527,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,15905015,Closed,systemuser,10 Sep 2025 16:16:14:547,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.547,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,15905016,Closed,systemuser,10 Sep 2025 16:16:14:570,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.570,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,15905017,Closed,systemuser,10 Sep 2025 16:16:14:800,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.800,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,15905018,Closed,systemuser,10 Sep 2025 16:16:14:820,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.820,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,15905009,Closed,systemuser,10 Sep 2025 16:16:14:400,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.400,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,15905008,Closed,systemuser,10 Sep 2025 16:16:14:380,systemuser,10 Sep 2025 16:16:53:593,systemuser,10 Sep 2025 16:16:53:593,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:16:14.380,20250910 16:16:53.593,20250910 16:16:53.593,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Mobility,Auto,15905041,Closed,systemuser,10 Sep 2025 16:17:32:717,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.717,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Self-Care,Auto,15905042,Closed,systemuser,10 Sep 2025 16:17:32:723,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.723,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Usual Activities,Auto,15905043,Closed,systemuser,10 Sep 2025 16:17:32:733,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.733,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Pain/Discomfort,Auto,15905044,Closed,systemuser,10 Sep 2025 16:17:32:740,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.740,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Anxiety/Depression,Auto,15905045,Closed,systemuser,10 Sep 2025 16:17:32:747,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.747,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Your health today,Auto,15905046,Closed,systemuser,10 Sep 2025 16:17:32:757,systemuser,10 Sep 2025 16:18:21:017,systemuser,10 Sep 2025 16:18:21:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.757,20250910 16:18:21.017,20250910 16:18:21.017,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,EQ-5D-5L,0/0/N,,Was the collection date the same as the visit date?,Auto,15905040,Closed,systemuser,10 Sep 2025 16:17:32:697,systemuser,10 Sep 2025 16:18:21:020,systemuser,10 Sep 2025 16:18:21:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:17:32.697,20250910 16:18:21.020,20250910 16:18:21.020,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,15830634,Closed,systemuser,05 Sep 2025 08:04:37:280,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.280,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,15830635,Closed,systemuser,05 Sep 2025 08:04:37:293,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.293,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,15830636,Closed,systemuser,05 Sep 2025 08:04:37:303,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.303,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,15830637,Closed,systemuser,05 Sep 2025 08:04:37:317,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.317,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,15830638,Closed,systemuser,05 Sep 2025 08:04:37:330,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.330,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,15830639,Closed,systemuser,05 Sep 2025 08:04:37:340,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.340,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,15830640,Closed,systemuser,05 Sep 2025 08:04:37:350,systemuser,05 Sep 2025 08:07:08:753,systemuser,05 Sep 2025 08:07:08:753,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.350,20250905 08:07:08.753,20250905 08:07:08.753,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,15830641,Closed,systemuser,05 Sep 2025 08:04:37:367,systemuser,05 Sep 2025 08:07:08:757,systemuser,05 Sep 2025 08:07:08:757,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.367,20250905 08:07:08.757,20250905 08:07:08.757,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,15830642,Closed,systemuser,05 Sep 2025 08:04:37:377,systemuser,05 Sep 2025 08:07:08:757,systemuser,05 Sep 2025 08:07:08:757,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.377,20250905 08:07:08.757,20250905 08:07:08.757,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,15830643,Closed,systemuser,05 Sep 2025 08:04:37:393,systemuser,05 Sep 2025 08:07:08:757,systemuser,05 Sep 2025 08:07:08:757,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.393,20250905 08:07:08.757,20250905 08:07:08.757,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,15830644,Closed,systemuser,05 Sep 2025 08:04:37:417,systemuser,05 Sep 2025 08:07:09:067,systemuser,05 Sep 2025 08:07:09:067,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.417,20250905 08:07:09.067,20250905 08:07:09.067,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Rater's Initials,Auto,15830633,Closed,systemuser,05 Sep 2025 08:04:37:270,systemuser,05 Sep 2025 08:07:08:773,systemuser,05 Sep 2025 08:07:08:773,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.270,20250905 08:07:08.773,20250905 08:07:08.773,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,15830632,Closed,systemuser,05 Sep 2025 08:04:37:240,systemuser,05 Sep 2025 08:07:08:773,systemuser,05 Sep 2025 08:07:08:773,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250905 08:04:37.240,20250905 08:07:08.773,20250905 08:07:08.773,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15904916,Closed,systemuser,10 Sep 2025 16:10:32:050,systemuser,10 Sep 2025 16:10:43:000,systemuser,10 Sep 2025 16:10:43:003,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:10:32.050,20250910 16:10:43.000,20250910 16:10:43.003,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20632399,Closed,systemuser,06 May 2026 05:30:19:990,systemuser,06 May 2026 05:30:26:263,systemuser,06 May 2026 05:30:26:263,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 05:30:19.990,20260506 05:30:26.263,20260506 05:30:26.263,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 5 Part 1 (1),Date of Visit,0/0/N,,Subject's Status,Auto,15905468,Closed,systemuser,10 Sep 2025 16:43:52:510,gnovotna@email.cz2,10 Sep 2025 16:50:15:550,Ashwini201,11 Sep 2025 11:34:29:740,,0,1,Required field.  Please complete or provide a response.,entry error,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:43:52.510,20250910 16:50:15.550,20250911 11:34:29.740,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 5 Part 1 (1),Date of Visit,0/0/N,,Did this visit occur?,Auto,15905467,Closed,systemuser,10 Sep 2025 16:43:52:497,gnovotna@email.cz2,10 Sep 2025 16:50:10:080,shyamaprasad972,12 Sep 2025 08:19:18:483,,0,2,Required field.  Please complete or provide a response.,entry error,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:43:52.497,20250910 16:50:10.080,20250912 08:19:18.483,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 5 Part 1 (1),Date of Visit,0/0/N,,Type of Contact,Auto,15905440,Closed,systemuser,10 Sep 2025 16:42:57:157,systemuser,12 Sep 2025 06:38:08:253,systemuser,12 Sep 2025 06:38:08:257,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:42:57.157,20250912 06:38:08.253,20250912 06:38:08.257,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 5 Part 1 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15905403,Closed,systemuser,10 Sep 2025 16:39:04:213,,,systemuser,10 Sep 2025 16:40:04:840,,,0,Data entered is in the future. Please correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:39:04.213,,20250910 16:40:04.840,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 5 Part 1 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15905408,Closed,systemuser,10 Sep 2025 16:40:05:650,,,systemuser,12 Sep 2025 06:38:07:030,,,2,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 16:40:05.650,,20250912 06:38:07.030,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16047295,Closed,systemuser,19 Sep 2025 12:00:43:200,systemuser,19 Sep 2025 12:01:14:090,systemuser,19 Sep 2025 12:01:14:093,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 12:00:43.200,20250919 12:01:14.090,20250919 12:01:14.093,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,16047293,Closed,systemuser,19 Sep 2025 12:00:43:173,systemuser,19 Sep 2025 12:01:14:100,systemuser,19 Sep 2025 12:01:14:100,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 12:00:43.173,20250919 12:01:14.100,20250919 12:01:14.100,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,16047294,Closed,systemuser,19 Sep 2025 12:00:43:187,systemuser,19 Sep 2025 12:01:14:103,systemuser,19 Sep 2025 12:01:14:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 12:00:43.187,20250919 12:01:14.103,20250919 12:01:14.103,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,16047291,Closed,systemuser,19 Sep 2025 12:00:43:110,systemuser,19 Sep 2025 12:01:14:103,systemuser,19 Sep 2025 12:01:14:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 12:00:43.110,20250919 12:01:14.103,20250919 12:01:14.103,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,16047292,Closed,systemuser,19 Sep 2025 12:00:43:157,systemuser,19 Sep 2025 12:01:14:103,systemuser,19 Sep 2025 12:01:14:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 12:00:43.157,20250919 12:01:14.103,20250919 12:01:14.103,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,16456853,Closed,systemuser,17 Oct 2025 10:35:34:167,systemuser,17 Oct 2025 10:36:23:513,systemuser,17 Oct 2025 10:36:23:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.167,20251017 10:36:23.513,20251017 10:36:23.513,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,16456854,Closed,systemuser,17 Oct 2025 10:35:34:180,systemuser,17 Oct 2025 10:36:23:513,systemuser,17 Oct 2025 10:36:23:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.180,20251017 10:36:23.513,20251017 10:36:23.513,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,16456855,Closed,systemuser,17 Oct 2025 10:35:34:190,systemuser,17 Oct 2025 10:36:23:513,systemuser,17 Oct 2025 10:36:23:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.190,20251017 10:36:23.513,20251017 10:36:23.513,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,16456856,Closed,systemuser,17 Oct 2025 10:35:34:200,systemuser,17 Oct 2025 10:36:23:513,systemuser,17 Oct 2025 10:36:23:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.200,20251017 10:36:23.513,20251017 10:36:23.513,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,16456857,Closed,systemuser,17 Oct 2025 10:35:34:207,systemuser,17 Oct 2025 10:36:23:513,systemuser,17 Oct 2025 10:36:23:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.207,20251017 10:36:23.513,20251017 10:36:23.513,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,16456852,Closed,systemuser,17 Oct 2025 10:35:34:150,,,systemuser,17 Oct 2025 10:36:23:530,,,0,The time entered is non-conformant. Please resolve.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.150,,20251017 10:36:23.530,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,16456858,Closed,systemuser,17 Oct 2025 10:35:34:217,systemuser,17 Oct 2025 10:36:23:530,systemuser,17 Oct 2025 10:36:23:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.217,20251017 10:36:23.530,20251017 10:36:23.530,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,16456860,Closed,systemuser,17 Oct 2025 10:35:34:233,systemuser,17 Oct 2025 10:36:23:530,systemuser,17 Oct 2025 10:36:23:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.233,20251017 10:36:23.530,20251017 10:36:23.530,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,16456859,Closed,systemuser,17 Oct 2025 10:35:34:227,systemuser,17 Oct 2025 10:36:23:530,systemuser,17 Oct 2025 10:36:23:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.227,20251017 10:36:23.530,20251017 10:36:23.530,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,16456861,Closed,systemuser,17 Oct 2025 10:35:34:243,systemuser,17 Oct 2025 10:36:23:530,systemuser,17 Oct 2025 10:36:23:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:35:34.243,20251017 10:36:23.530,20251017 10:36:23.530,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,16456518,Closed,systemuser,17 Oct 2025 10:06:24:577,systemuser,20 Oct 2025 07:46:24:710,systemuser,20 Oct 2025 07:46:24:713,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:06:24.577,20251020 07:46:24.710,20251020 07:46:24.713,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040001,Enrolled,Visit 8 Part 1 (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,16456833,Closed,systemuser,17 Oct 2025 10:33:30:150,systemuser,20 Oct 2025 07:46:32:537,systemuser,20 Oct 2025 07:46:32:537,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 10:33:30.150,20251020 07:46:32.537,20251020 07:46:32.537,98,335,335,31,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Action Taken with Study Treatment,DM,17675499,Closed,Juhita@ksha4,05 Dec 2025 13:33:46:587,BrezVe1,08 Dec 2025 08:37:54:710,Juhita@ksha4,09 Dec 2025 06:38:19:613,,3,1,Medical Review I-941081: Start date for the AE was before the first dose of IP. Kindly update the Correct action taken.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:33:46.587,20251208 08:37:54.710,20251209 06:38:19.613,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,End Date,Auto,18402625,Closed,systemuser,12 Jan 2026 18:07:13:433,gnovotna@email.cz2,12 Jan 2026 18:07:21:143,Ashwini201,13 Jan 2026 10:43:01:710,,0,1,"If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.",the symptom appeared after starting the medication,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260112 18:07:13.433,20260112 18:07:21.143,20260113 10:43:01.710,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Outcome,Auto,18402626,Closed,systemuser,12 Jan 2026 18:07:13:450,systemuser,12 Jan 2026 18:07:47:323,systemuser,12 Jan 2026 18:07:47:343,,0,0,"End of event is marked as 'Ongoing' so the outcome is expected to be 'Not Recovered/Not Resolved', 'Recovering/Resolving' or 'Unknown'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260112 18:07:13.450,20260112 18:07:47.323,20260112 18:07:47.343,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Relationship to Study Treatment,DM,18328091,Closed,Juhita@ksha4,07 Jan 2026 09:46:00:683,gnovotna@email.cz2,12 Jan 2026 18:08:08:130,Juhita@ksha4,13 Jan 2026 14:07:13:497,,5,1,Medical Review I-1712949: Kindly clarify rationality to consider AE to be related to study drug.,the symptom appeared after starting the medication,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 09:46:00.683,20260112 18:08:08.130,20260113 14:07:13.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Start Time,Auto,17058241,Closed,systemuser,18 Nov 2025 08:29:48:313,,,systemuser,18 Nov 2025 08:29:58:000,,,0,The time entered is non-conformant. Please resolve.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:29:48.313,,20251118 08:29:58.000,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,3,Action Taken with Study Treatment,Auto,20758446,Closed,systemuser,11 May 2026 10:06:44:377,systemuser,11 May 2026 10:06:50:990,systemuser,11 May 2026 10:06:50:993,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260511 10:06:44.377,20260511 10:06:50.990,20260511 10:06:50.993,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Dose Form,Auto,16068755,Closed,systemuser,22 Sep 2025 14:35:06:253,systemuser,22 Sep 2025 14:40:16:103,systemuser,22 Sep 2025 14:40:16:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.253,20250922 14:40:16.103,20250922 14:40:16.103,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Frequency,Auto,16068756,Closed,systemuser,22 Sep 2025 14:35:06:263,systemuser,22 Sep 2025 14:40:16:103,systemuser,22 Sep 2025 14:40:16:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.263,20250922 14:40:16.103,20250922 14:40:16.103,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Dose Unit,Auto,16068754,Closed,systemuser,22 Sep 2025 14:35:06:160,systemuser,22 Sep 2025 14:40:16:103,systemuser,22 Sep 2025 14:40:16:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.160,20250922 14:40:16.103,20250922 14:40:16.103,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,What was the individual dose of the medication/therapy?,Auto,16068753,Closed,systemuser,22 Sep 2025 14:35:06:147,systemuser,22 Sep 2025 14:40:16:120,systemuser,22 Sep 2025 14:40:16:120,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.147,20250922 14:40:16.120,20250922 14:40:16.120,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,What was the individual dose of the medication/therapy?,Auto,16068835,Closed,systemuser,22 Sep 2025 14:40:16:157,,,systemuser,22 Sep 2025 14:41:21:310,,,0,Dose contains a space or a comma or a non-numeric character; Please correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:40:16.157,,20250922 14:41:21.310,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,What was the individual dose of the medication/therapy?,Auto,16068858,Closed,systemuser,22 Sep 2025 14:41:21:377,systemuser,22 Sep 2025 14:47:02:793,systemuser,22 Sep 2025 14:47:02:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:41:21.377,20250922 14:47:02.793,20250922 14:47:02.797,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Route,Auto,16068757,Closed,systemuser,22 Sep 2025 14:35:06:273,systemuser,22 Sep 2025 14:40:16:120,systemuser,22 Sep 2025 14:40:16:120,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.273,20250922 14:40:16.120,20250922 14:40:16.120,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Start Date,Auto,16068758,Closed,systemuser,22 Sep 2025 14:35:06:287,systemuser,22 Sep 2025 14:38:47:380,systemuser,22 Sep 2025 14:38:47:383,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:35:06.287,20250922 14:38:47.380,20250922 14:38:47.383,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260325 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19153601,Closed,systemuser,24 Feb 2026 13:57:12:293,systemuser,25 Mar 2026 07:21:44:973,systemuser,25 Mar 2026 07:21:45:313,,29,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 13:57:12.293,20260325 07:21:44.973,20260325 07:21:45.313,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,4,Stop date of menstrual period,DM,19438167,Closed,JThoma858,10 Mar 2026 08:43:47:730,gnovotna@email.cz2,20 Mar 2026 11:31:02:830,JThoma858,23 Mar 2026 05:44:09:063,,10,3,DM :Please update the Menstrual Cycle Tracking Log for the month of Jan and Feb. Else clarify,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:43:47.730,20260320 11:31:02.830,20260323 05:44:09.063,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,4,Start date of menstrual period,DM,19438144,Cancelled,JThoma858,10 Mar 2026 08:43:21:033,,,JThoma858,10 Mar 2026 08:43:23:813,,,,Please update the Menstrual Cycle Tracking Log for the month of Jan and Feb 2026.  Else clarify,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:43:21.033,,20260310 08:43:23.813,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,17405294,Closed,systemuser,28 Nov 2025 09:37:45:270,,,systemuser,28 Nov 2025 10:43:14:937,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251128 09:37:45.270,,20251128 10:43:14.937,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17286870,Closed,Ashwini201,25 Nov 2025 13:52:22:370,gnovotna@email.cz2,28 Nov 2025 10:45:11:557,SanchariDutta@025,01 Dec 2025 07:18:19:053,,3,3,"DM: Please verify and update the data on Arizona Sexual Experiences Scale Summary and Local Labs for Background Antidepressant Compliance forms, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 13:52:22.370,20251128 10:45:11.557,20251201 07:18:19.053,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,Is the medical history disease/condition or event still ongoing?,DM,18269716,Closed,Juhita@ksha4,31 Dec 2025 12:22:45:913,BrezVe1,05 Jan 2026 09:54:32:967,Juhita@ksha4,06 Jan 2026 12:27:54:603,,5,1,Medical Review I-941339: Please confirm if MH is still ongoing or else update the end date. Kindly mention the cause of MH term.,ongoing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251231 12:22:45.913,20260105 09:54:32.967,20260106 12:27:54.603,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,DM,16312156,Closed,CoderImport,08 Oct 2025 06:09:13:050,gnovotna@email.cz2,10 Oct 2025 09:55:24:083,systemuser,10 Oct 2025 09:55:24:197,,2,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251008 06:09:13.050,20251010 09:55:24.083,20251010 09:55:24.197,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,DM,16312157,Closed,CoderImport,08 Oct 2025 06:09:15:857,gnovotna@email.cz2,10 Oct 2025 09:56:20:187,systemuser,10 Oct 2025 09:56:20:307,,2,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251008 06:09:15.857,20251010 09:56:20.187,20251010 09:56:20.307,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,DM,16619228,Closed,CoderImport,28 Oct 2025 06:34:12:423,BrezVe1,03 Nov 2025 08:40:31:453,systemuser,03 Nov 2025 08:40:31:580,,6,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251028 06:34:12.423,20251103 08:40:31.453,20251103 08:40:31.580,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,General Medical History,0/0/N,5,What is the verbatim term for the medical history condition/event?,DM,16619229,Closed,CoderImport,28 Oct 2025 06:34:15:197,BrezVe1,03 Nov 2025 08:40:44:253,systemuser,03 Nov 2025 08:40:44:430,,6,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251028 06:34:15.197,20251103 08:40:44.253,20251103 08:40:44.430,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Current Method(s) of Contraception,DM,16111828,Closed,Ashwini201,24 Sep 2025 10:28:47:630,BrezVe1,02 Oct 2025 07:00:55:593,Ashwini201,03 Oct 2025 07:36:10:310,,8,1,"DM: As the logline2 added by error, kindly inactive the same.",Inactivated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 10:28:47.630,20251002 07:00:55.593,20251003 07:36:10.310,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",Auto,16068121,Closed,systemuser,22 Sep 2025 14:00:15:630,systemuser,22 Sep 2025 14:41:44:780,systemuser,22 Sep 2025 14:41:44:783,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:00:15.630,20250922 14:41:44.780,20250922 14:41:44.783,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Lifetime Manic Episode,Auto,16068428,Closed,systemuser,22 Sep 2025 14:18:14:257,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.257,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Lifetime Hypomanic Episode ,Auto,16068429,Closed,systemuser,22 Sep 2025 14:18:14:290,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.290,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,History of Primary psychotic or psychotic depression symptoms (except during past mood episodes),Auto,16068430,Closed,systemuser,22 Sep 2025 14:18:14:323,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.323,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Moderate to severe Alcohol Use Disorder in past 6 months,Auto,16068431,Closed,systemuser,22 Sep 2025 14:18:14:360,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.360,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Moderate to severe Substance Use Disorder (other than nicotine) in past 6 months,Auto,16068432,Closed,systemuser,22 Sep 2025 14:18:14:393,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.393,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Obsessive-Compulsive Disorder in past year,Auto,16068433,Closed,systemuser,22 Sep 2025 14:18:14:430,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.430,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,PTSD in past year,Auto,16068434,Closed,systemuser,22 Sep 2025 14:18:14:503,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.503,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Anorexia Nervosa in past year,Auto,16068435,Closed,systemuser,22 Sep 2025 14:18:14:533,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.533,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Bulimia Nervosa in past year,Auto,16068436,Closed,systemuser,22 Sep 2025 14:18:14:550,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.550,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Panic Disorder past 2 years that was focus of tx,Auto,16068437,Closed,systemuser,22 Sep 2025 14:18:14:563,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.563,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Generalized Anxiety Disorder past 2 years that was focus of tx,Auto,16068438,Closed,systemuser,22 Sep 2025 14:18:14:573,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.573,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Social Anxiety Disorder past 2 years that was focus of tx,Auto,16068439,Closed,systemuser,22 Sep 2025 14:18:14:583,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.583,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Specific Phobia past 2 years that was focus of tx,Auto,16068440,Closed,systemuser,22 Sep 2025 14:18:14:597,systemuser,22 Sep 2025 14:19:12:960,systemuser,22 Sep 2025 14:19:12:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.597,20250922 14:19:12.960,20250922 14:19:12.960,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Symptoms of insomnia in the MDD criteria,Auto,16068427,Closed,systemuser,22 Sep 2025 14:18:14:217,systemuser,22 Sep 2025 14:19:12:963,systemuser,22 Sep 2025 14:19:12:963,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.217,20250922 14:19:12.963,20250922 14:19:12.963,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 1,SCID-CT,0/0/V,,Current MDE,Auto,16068426,Closed,systemuser,22 Sep 2025 14:18:14:187,systemuser,22 Sep 2025 14:19:12:963,systemuser,22 Sep 2025 14:19:12:963,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250922 14:18:14.187,20250922 14:19:12.963,20250922 14:19:12.963,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,1,Assessment Completed?,DM,16909587,Closed,Juhita@ksha4,11 Nov 2025 07:20:30:677,BrezVe1,18 Nov 2025 09:10:21:810,Juhita@ksha4,24 Nov 2025 08:06:46:617,,7,6,ECOA: Please verify and update the data for the field &quot;Assessment Completed?&quot;,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 07:20:30.677,20251118 09:10:21.810,20251124 08:06:46.617,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/V,1,Start Date,Auto,19338057,Closed,systemuser,06 Mar 2026 10:03:12:880,,,systemuser,09 Mar 2026 10:23:01:597,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 10:03:12.880,,20260309 10:23:01.597,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,DM,18527647,Closed,Juhita@ksha4,20 Jan 2026 09:18:41:697,BrezVe1,26 Jan 2026 07:32:25:360,Juhita@ksha4,27 Jan 2026 09:25:14:317,,6,1,DM: Kindly refer the completion guideline and update the end date as appropriate.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 09:18:41.697,20260126 07:32:25.360,20260127 09:25:14.317,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,16458267,Closed,systemuser,17 Oct 2025 11:41:10:687,,,systemuser,20 Oct 2025 07:50:24:940,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 11:41:10.687,,20251020 07:50:24.940,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,DM,18630752,Cancelled,Juhita@ksha4,27 Jan 2026 09:25:19:613,,,kminarov1,27 Jan 2026 12:23:46:467,,,,DM: Kindly refer the completion guideline and update the end date as appropriate.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260127 09:25:19.613,,20260127 12:23:46.467,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,DM,20823448,Closed,JThoma858,13 May 2026 12:51:51:393,gnovotna@email.cz2,13 May 2026 13:52:53:817,Ashwini201,14 May 2026 07:08:45:327,,0,1,DM: The Start Date of Part 1 should align with Visit Baseline Day 3 or Randomization Date. Kindly recheck and update ,entry error,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260513 12:51:51.393,20260513 13:52:53.817,20260514 07:08:45.327,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,18764037,Closed,Juhita@ksha4,04 Feb 2026 11:25:56:670,BrezVe1,09 Feb 2026 08:39:26:660,Juhita@ksha4,16 Feb 2026 14:37:41:227,,5,7,Medical Review I-1908866: Please complete the end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260204 11:25:56.670,20260209 08:39:26.660,20260216 14:37:41.227,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,19098873,Cancelled,Juhita@ksha4,20 Feb 2026 14:16:26:240,,,kminarov1,24 Feb 2026 10:38:43:130,,,,RQ MR1 I-1908866: Please update the end date as per the completion guidelines.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 14:16:26.240,,20260224 10:38:43.130,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,Auto,19138990,Closed,systemuser,24 Feb 2026 07:16:56:997,systemuser,24 Feb 2026 07:17:14:687,systemuser,24 Feb 2026 07:17:14:687,,0,0,The End Date must be equal to or after the Start Date. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 07:16:56.997,20260224 07:17:14.687,20260224 07:17:14.687,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,17405293,Closed,systemuser,28 Nov 2025 09:37:45:257,,,systemuser,01 Dec 2025 08:36:47:543,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251128 09:37:45.257,,20251201 08:36:47.543,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Number of tablets taken,Auto,19139010,Closed,systemuser,24 Feb 2026 07:17:57:280,systemuser,24 Feb 2026 07:18:18:727,systemuser,24 Feb 2026 07:18:18:727,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 07:17:57.280,20260224 07:18:18.727,20260224 07:18:18.727,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,End Date,DM,19613020,Closed,Juhita@ksha4,20 Mar 2026 07:53:07:357,BrezVe1,23 Mar 2026 13:19:13:727,Juhita@ksha4,25 Mar 2026 15:23:51:033,,3,2,Medical Review I-3085480: Please provide end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260320 07:53:07.357,20260323 13:19:13.727,20260325 15:23:51.033,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,18368673,Closed,systemuser,09 Jan 2026 08:54:57:037,BrezVe1,26 Jan 2026 07:33:23:667,Juhita@ksha4,20 Feb 2026 14:16:43:470,,17,25,Please enter study drug administration start date as soon as it's available,will be done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260109 08:54:57.037,20260126 07:33:23.667,20260220 14:16:43.470,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,DM,19098884,Closed,Juhita@ksha4,20 Feb 2026 14:17:31:737,EHerman2,24 Feb 2026 07:18:30:140,Ashwini201,26 Feb 2026 08:32:26:103,,4,2,RQ DM1: Please verify and update the start date as per the completion guidelines.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 14:17:31.737,20260224 07:18:30.140,20260226 08:32:26.103,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 1.4 Induction (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,17984476,Closed,systemuser,15 Dec 2025 08:11:37:313,systemuser,15 Dec 2025 08:11:42:293,systemuser,15 Dec 2025 08:11:42:297,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 08:11:37.313,20251215 08:11:42.293,20251215 08:11:42.297,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17984366,Closed,systemuser,15 Dec 2025 08:03:17:520,systemuser,15 Dec 2025 08:05:39:303,systemuser,15 Dec 2025 08:05:39:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 08:03:17.520,20251215 08:05:39.303,20251215 08:05:39.307,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 1.6 Induction (1),Date of Visit,0/0/N,,Visit Start Date,Auto,18368084,Closed,systemuser,09 Jan 2026 08:22:45:707,,,systemuser,09 Jan 2026 08:28:31:913,,,0,Date of visit should be greater than the last date of visit. Please reconcile.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260109 08:22:45.707,,20260109 08:28:31.913,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18823558,Closed,systemuser,09 Feb 2026 08:26:27:617,systemuser,09 Feb 2026 08:26:45:607,systemuser,09 Feb 2026 08:26:45:610,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:27.617,20260209 08:26:45.607,20260209 08:26:45.610,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Pulse,Auto,18823556,Closed,systemuser,09 Feb 2026 08:26:27:600,systemuser,09 Feb 2026 08:26:45:617,systemuser,09 Feb 2026 08:26:45:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:27.600,20260209 08:26:45.617,20260209 08:26:45.617,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18823557,Closed,systemuser,09 Feb 2026 08:26:27:610,systemuser,09 Feb 2026 08:26:45:620,systemuser,09 Feb 2026 08:26:45:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:27.610,20260209 08:26:45.620,20260209 08:26:45.620,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,18823554,Closed,systemuser,09 Feb 2026 08:26:27:577,systemuser,09 Feb 2026 08:26:45:620,systemuser,09 Feb 2026 08:26:45:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:27.577,20260209 08:26:45.620,20260209 08:26:45.620,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature,Auto,18823555,Closed,systemuser,09 Feb 2026 08:26:27:590,systemuser,09 Feb 2026 08:26:45:620,systemuser,09 Feb 2026 08:26:45:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:27.590,20260209 08:26:45.620,20260209 08:26:45.620,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18823561,Closed,systemuser,09 Feb 2026 08:26:45:663,systemuser,09 Feb 2026 08:27:03:847,systemuser,09 Feb 2026 08:27:03:850,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 08:26:45.663,20260209 08:27:03.847,20260209 08:27:03.850,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.4 Stabilization,Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,19336124,Closed,systemuser,06 Mar 2026 08:28:08:773,systemuser,06 Mar 2026 08:28:40:480,systemuser,06 Mar 2026 08:28:40:480,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 08:28:08.773,20260306 08:28:40.480,20260306 08:28:40.480,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.4 Stabilization,Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,19336122,Closed,systemuser,06 Mar 2026 08:28:08:753,systemuser,06 Mar 2026 08:28:40:497,systemuser,06 Mar 2026 08:28:40:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 08:28:08.753,20260306 08:28:40.497,20260306 08:28:40.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.4 Stabilization,Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,19336123,Closed,systemuser,06 Mar 2026 08:28:08:767,systemuser,06 Mar 2026 08:28:40:497,systemuser,06 Mar 2026 08:28:40:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 08:28:08.767,20260306 08:28:40.497,20260306 08:28:40.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 2.4 Stabilization,Neurologic Examination,0/0/N,5,Are there any findings?,Auto,19396887,Closed,systemuser,09 Mar 2026 10:41:43:360,systemuser,09 Mar 2026 10:41:56:387,systemuser,09 Mar 2026 10:41:56:390,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260309 10:41:43.360,20260309 10:41:56.387,20260309 10:41:56.390,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,18173020,Closed,Ashwini201,23 Dec 2025 07:03:32:433,BrezVe1,05 Jan 2026 09:56:29:570,shyamaprasad972,06 Jan 2026 11:23:32:980,,13,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:03:32.433,20260105 09:56:29.570,20260106 11:23:32.980,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,16459162,Closed,systemuser,17 Oct 2025 11:59:08:200,systemuser,17 Oct 2025 11:59:25:183,systemuser,17 Oct 2025 11:59:25:187,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 11:59:08.200,20251017 11:59:25.183,20251017 11:59:25.187,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,16459195,Closed,systemuser,17 Oct 2025 12:00:54:257,systemuser,20 Oct 2025 07:50:34:810,systemuser,20 Oct 2025 07:50:34:810,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 12:00:54.257,20251020 07:50:34.810,20251020 07:50:34.810,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16729218,Closed,systemuser,03 Nov 2025 08:24:50:880,systemuser,03 Nov 2025 08:25:09:110,systemuser,03 Nov 2025 08:25:09:113,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:24:50.880,20251103 08:25:09.110,20251103 08:25:09.113,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,16729216,Closed,systemuser,03 Nov 2025 08:24:50:847,systemuser,03 Nov 2025 08:25:09:123,systemuser,03 Nov 2025 08:25:09:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:24:50.847,20251103 08:25:09.123,20251103 08:25:09.123,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,16729217,Closed,systemuser,03 Nov 2025 08:24:50:860,systemuser,03 Nov 2025 08:25:09:127,systemuser,03 Nov 2025 08:25:09:127,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:24:50.860,20251103 08:25:09.127,20251103 08:25:09.127,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,16729214,Closed,systemuser,03 Nov 2025 08:24:50:787,systemuser,03 Nov 2025 08:25:09:127,systemuser,03 Nov 2025 08:25:09:127,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:24:50.787,20251103 08:25:09.127,20251103 08:25:09.127,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,16729215,Closed,systemuser,03 Nov 2025 08:24:50:830,systemuser,03 Nov 2025 08:25:09:127,systemuser,03 Nov 2025 08:25:09:127,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:24:50.830,20251103 08:25:09.127,20251103 08:25:09.127,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16729228,Closed,systemuser,03 Nov 2025 08:25:09:313,systemuser,03 Nov 2025 08:25:14:887,systemuser,03 Nov 2025 08:25:14:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251103 08:25:09.313,20251103 08:25:14.887,20251103 08:25:14.890,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,17057786,Closed,systemuser,18 Nov 2025 08:18:55:217,systemuser,18 Nov 2025 08:19:32:423,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.217,20251118 08:19:32.423,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,17057787,Closed,systemuser,18 Nov 2025 08:18:55:223,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.223,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,17057788,Closed,systemuser,18 Nov 2025 08:18:55:230,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.230,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,17057789,Closed,systemuser,18 Nov 2025 08:18:55:240,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.240,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,17057790,Closed,systemuser,18 Nov 2025 08:18:55:250,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.250,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,17057791,Closed,systemuser,18 Nov 2025 08:18:55:257,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.257,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,17057792,Closed,systemuser,18 Nov 2025 08:18:55:263,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.263,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,17057793,Closed,systemuser,18 Nov 2025 08:18:55:283,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.283,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,17057794,Closed,systemuser,18 Nov 2025 08:18:55:293,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.293,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,17057795,Closed,systemuser,18 Nov 2025 08:18:55:313,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.313,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,17057785,Closed,systemuser,18 Nov 2025 08:18:55:203,systemuser,18 Nov 2025 08:19:32:427,systemuser,18 Nov 2025 08:19:32:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:18:55.203,20251118 08:19:32.427,20251118 08:19:32.427,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17057739,Closed,systemuser,18 Nov 2025 08:16:35:420,systemuser,18 Nov 2025 08:17:02:640,systemuser,18 Nov 2025 08:17:02:643,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:16:35.420,20251118 08:17:02.640,20251118 08:17:02.643,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Action Taken with Study Treatment,Auto,19645338,Closed,systemuser,23 Mar 2026 13:01:56:090,systemuser,23 Mar 2026 13:02:38:650,systemuser,23 Mar 2026 13:02:38:657,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.090,20260323 13:02:38.650,20260323 13:02:38.657,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Concomitant or additional therapy given for this adverse event?,Auto,19645339,Closed,systemuser,23 Mar 2026 13:01:56:100,systemuser,23 Mar 2026 13:02:38:680,systemuser,23 Mar 2026 13:02:38:680,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.100,20260323 13:02:38.680,20260323 13:02:38.680,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,End Time,Auto,19645336,Closed,systemuser,23 Mar 2026 13:01:56:067,,,systemuser,23 Mar 2026 13:02:38:680,,,0,The time entered is non-conformant. Please resolve.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.067,,20260323 13:02:38.680,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Outcome,Auto,19645341,Closed,systemuser,23 Mar 2026 13:01:56:120,systemuser,23 Mar 2026 13:02:38:733,systemuser,23 Mar 2026 13:02:38:733,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.120,20260323 13:02:38.733,20260323 13:02:38.733,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Relationship to Study Treatment,Auto,19645340,Closed,systemuser,23 Mar 2026 13:01:56:110,systemuser,23 Mar 2026 13:02:38:710,systemuser,23 Mar 2026 13:02:38:710,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.110,20260323 13:02:38.710,20260323 13:02:38.710,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Is the adverse event serious?,Auto,19645344,Closed,systemuser,23 Mar 2026 13:01:56:147,systemuser,23 Mar 2026 13:02:38:733,systemuser,23 Mar 2026 13:02:38:733,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.147,20260323 13:02:38.733,20260323 13:02:38.733,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Severity,Auto,19645337,Closed,systemuser,23 Mar 2026 13:01:56:080,systemuser,23 Mar 2026 13:02:38:710,systemuser,23 Mar 2026 13:02:38:710,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:01:56.080,20260323 13:02:38.710,20260323 13:02:38.710,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,,Were any medication(s)/therapy(ies) taken?,Site from Medical Reviewer,16450227,Closed,inayath1,17 Oct 2025 04:02:59:650,BrezVe1,20 Oct 2025 07:53:12:603,inayath1,21 Oct 2025 02:28:10:317,,3,1,Eligibility: Please confirm the exact dose of Metoprolol subject is taking per day as 2 loglines (CM#5 and CM#6) are updated with different doses and both ongoing.,"data are correct, subject is  taking 50 mg in the morning and a different dose of 25 mg in the evening",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 04:02:59.650,20251020 07:53:12.603,20251021 02:28:10.317,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,19065707,Closed,systemuser,19 Feb 2026 07:39:37:413,EHerman2,19 Feb 2026 07:40:52:457,Ashwini201,20 Feb 2026 06:57:43:423,,0,1,The selected logline has been modified from  '#002 > HYPERCHOLESTEROLÉMIA' to '#002 > HYPERCHOLESTEROLEMIA' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,confirm,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260219 07:39:37.413,20260219 07:40:52.457,20260220 06:57:43.423,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,4,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,19065708,Closed,systemuser,19 Feb 2026 07:39:37:507,EHerman2,19 Feb 2026 07:41:34:817,Ashwini201,20 Feb 2026 06:57:54:033,,0,1,The selected logline has been modified from  '#002 > HYPERCHOLESTEROLÉMIA' to '#002 > HYPERCHOLESTEROLEMIA' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,confirm,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260219 07:39:37.507,20260219 07:41:34.817,20260220 06:57:54.033,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260325 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19645327,Closed,systemuser,23 Mar 2026 13:00:57:817,systemuser,25 Mar 2026 07:22:24:580,systemuser,25 Mar 2026 07:22:24:920,,2,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 13:00:57.817,20260325 07:22:24.580,20260325 07:22:24.920,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933281,Closed,systemuser,20 May 2026 12:07:32:407,,,systemuser,20 May 2026 12:07:50:240,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:07:32.407,,20260520 12:07:50.240,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,18121392,Closed,systemuser,19 Dec 2025 09:51:11:170,,,systemuser,22 Dec 2025 10:48:45:833,,,3,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 09:51:11.170,,20251222 10:48:45.833,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16450305,Closed,inayath1,17 Oct 2025 04:24:58:700,BrezVe1,20 Oct 2025 07:54:23:983,inayath1,21 Oct 2025 02:28:56:263,,3,1,"Eligibility: The subject had abnormal urinalysis with presence of bacteria and 3+ leukocyte esterase. Please confirm if this is a clinically significance, per investigator judgment, and exclusion #19 is ruled out.",not clinically significant,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 04:24:58.700,20251020 07:54:23.983,20251021 02:28:56.263,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17286944,Closed,Ashwini201,25 Nov 2025 13:55:36:933,gnovotna@email.cz2,28 Nov 2025 10:45:47:890,SanchariDutta@025,01 Dec 2025 07:17:03:837,,3,3,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 13:55:36.933,20251128 10:45:47.890,20251201 07:17:03.837,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,General Medical History,0/0/N,,"Has the subject experienced any past and/ or concomitant diseases?  If 'Yes', add a log line for each abnormality.",Auto,16381703,Closed,systemuser,13 Oct 2025 14:03:36:957,systemuser,13 Oct 2025 14:04:53:773,systemuser,13 Oct 2025 14:04:53:773,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251013 14:03:36.957,20251013 14:04:53.773,20251013 14:04:53.773,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,DM,18305826,Closed,Juhita@ksha4,06 Jan 2026 06:49:22:013,gnovotna@email.cz2,13 Jan 2026 17:24:40:197,Juhita@ksha4,15 Jan 2026 14:17:15:253,,7,2,"Medical Review I-1707449: Kindly mention the type of arrhythmia, the clinical stability and frequency of Cardiac arrhythmia.","patient is clinical stably, after starting medication, the arrhythmias disappeared",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260106 06:49:22.013,20260113 17:24:40.197,20260115 14:17:15.253,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16450258,Closed,inayath1,17 Oct 2025 04:12:12:890,BrezVe1,20 Oct 2025 07:58:22:110,inayath1,21 Oct 2025 02:34:06:163,,3,1,Eligibility: Please consider updating the indication for surgery also in a separate logline.,please unfreeze logline 5 for data entry,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 04:12:12.890,20251020 07:58:22.110,20251021 02:34:06.163,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16484927 (16450258),Closed,inayath1,21 Oct 2025 02:34:06:307,gnovotna@email.cz2,24 Oct 2025 15:23:45:963,inayath1,25 Oct 2025 10:52:07:983,,3,1,Eligibility: Please consider updating the details in a new logline.,"cholecystectomia for cholecystolithiasis, updated in line 5",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251021 02:34:06.307,20251024 15:23:45.963,20251025 10:52:07.983,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16381569,Closed,systemuser,13 Oct 2025 13:56:00:893,systemuser,13 Oct 2025 13:56:06:050,systemuser,13 Oct 2025 13:56:06:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251013 13:56:00.893,20251013 13:56:06.050,20251013 13:56:06.053,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,17675428,Closed,Ashwini201,05 Dec 2025 13:31:24:357,BrezVe1,08 Dec 2025 08:29:58:700,Ashwini201,09 Dec 2025 10:08:48:947,,3,1,"DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:31:24.357,20251208 08:29:58.700,20251209 10:08:48.947,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Screening Visit 2 (1),SIGH-D-17,0/0/N,,Collection Date,Auto,16819247,Closed,systemuser,06 Nov 2025 08:08:02:013,systemuser,06 Nov 2025 08:09:23:450,systemuser,06 Nov 2025 08:09:23:450,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 08:08:02.013,20251106 08:09:23.450,20251106 08:09:23.450,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/V,1,Start Date,Auto,19739140,Closed,systemuser,27 Mar 2026 09:57:52:020,,,systemuser,30 Mar 2026 09:19:06:300,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260327 09:57:52.020,,20260330 09:19:06.300,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,DM,18527672,Closed,Juhita@ksha4,20 Jan 2026 09:19:32:410,BrezVe1,26 Jan 2026 06:40:04:157,Juhita@ksha4,27 Jan 2026 09:24:21:293,,6,1,DM: Kindly refer the completion guideline and update the end date as appropriate.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 09:19:32.410,20260126 06:40:04.157,20260127 09:24:21.293,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,16851126,Closed,systemuser,07 Nov 2025 10:11:08:747,,,systemuser,10 Nov 2025 12:38:14:997,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 10:11:08.747,,20251110 12:38:14.997,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,18121391,Closed,systemuser,19 Dec 2025 09:51:11:157,,,systemuser,22 Dec 2025 10:49:13:390,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 09:51:11.157,,20251222 10:49:13.390,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,18693645,Closed,systemuser,30 Jan 2026 08:08:11:847,,,systemuser,02 Feb 2026 15:51:40:760,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260130 08:08:11.847,,20260202 15:51:40.760,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.5 Induction (1),Date of Visit,0/0/N,,Visit Start Date,Auto,18476460,Closed,systemuser,16 Jan 2026 09:27:36:950,,,systemuser,16 Jan 2026 09:27:52:367,,,0,Date of visit should be greater than the last date of visit. Please reconcile.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 09:27:36.950,,20260116 09:27:52.367,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18611495,Closed,systemuser,26 Jan 2026 06:36:35:650,systemuser,26 Jan 2026 06:36:42:390,systemuser,26 Jan 2026 06:36:42:393,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260126 06:36:35.650,20260126 06:36:42.390,20260126 06:36:42.393,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,The symptoms have disrupted your work / school work,Auto,18715622,Closed,systemuser,02 Feb 2026 08:16:49:360,systemuser,02 Feb 2026 08:17:41:787,systemuser,02 Feb 2026 08:17:41:790,,0,0,Either 'The symptoms have disrupted...' or 'I have not worked/studied ...' must be answered. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.360,20260202 08:17:41.787,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,The symptoms have disrupted your social life / leisure activities,Auto,18715623,Closed,systemuser,02 Feb 2026 08:16:49:370,systemuser,02 Feb 2026 08:17:41:790,systemuser,02 Feb 2026 08:17:41:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.370,20260202 08:17:41.790,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,The symptoms have disrupted your family life / home responsibilities,Auto,18715624,Closed,systemuser,02 Feb 2026 08:16:49:377,systemuser,02 Feb 2026 08:17:41:790,systemuser,02 Feb 2026 08:17:41:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.377,20260202 08:17:41.790,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities?,Auto,18715625,Closed,systemuser,02 Feb 2026 08:16:49:387,systemuser,02 Feb 2026 08:17:41:790,systemuser,02 Feb 2026 08:17:41:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.387,20260202 08:17:41.790,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,"On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work or had other daily responsibilities, your productivity was reduced?",Auto,18715626,Closed,systemuser,02 Feb 2026 08:16:49:420,systemuser,02 Feb 2026 08:17:41:790,systemuser,02 Feb 2026 08:17:41:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.420,20260202 08:17:41.790,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Sheehan Disability Scale,0/0/N,,Was the collection date the same as the visit date?,Auto,18715621,Closed,systemuser,02 Feb 2026 08:16:49:343,systemuser,02 Feb 2026 08:17:41:790,systemuser,02 Feb 2026 08:17:41:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:16:49.343,20260202 08:17:41.790,20260202 08:17:41.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18715353,Closed,systemuser,02 Feb 2026 07:57:44:863,systemuser,02 Feb 2026 07:58:20:480,systemuser,02 Feb 2026 07:58:20:480,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.863,20260202 07:58:20.480,20260202 07:58:20.480,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Pulse,Auto,18715351,Closed,systemuser,02 Feb 2026 07:57:44:847,systemuser,02 Feb 2026 07:58:20:490,systemuser,02 Feb 2026 07:58:20:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.847,20260202 07:58:20.490,20260202 07:58:20.490,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18715352,Closed,systemuser,02 Feb 2026 07:57:44:857,systemuser,02 Feb 2026 07:58:20:497,systemuser,02 Feb 2026 07:58:20:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.857,20260202 07:58:20.497,20260202 07:58:20.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,18715348,Closed,systemuser,02 Feb 2026 07:57:44:817,systemuser,02 Feb 2026 07:58:20:497,systemuser,02 Feb 2026 07:58:20:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.817,20260202 07:58:20.497,20260202 07:58:20.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Temperature,Auto,18715350,Closed,systemuser,02 Feb 2026 07:57:44:840,systemuser,02 Feb 2026 07:58:20:497,systemuser,02 Feb 2026 07:58:20:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.840,20260202 07:58:20.497,20260202 07:58:20.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Weight,Auto,18715349,Closed,systemuser,02 Feb 2026 07:57:44:830,systemuser,02 Feb 2026 07:58:20:497,systemuser,02 Feb 2026 07:58:20:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 07:57:44.830,20260202 07:58:20.497,20260202 07:58:20.497,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 2.4 Stabilization,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19753970,Closed,systemuser,30 Mar 2026 08:22:52:750,systemuser,30 Mar 2026 08:26:56:013,systemuser,30 Mar 2026 08:26:56:013,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 08:22:52.750,20260330 08:26:56.013,20260330 08:26:56.013,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,18173047,Closed,Ashwini201,23 Dec 2025 07:06:45:213,BrezVe1,05 Jan 2026 09:58:58:060,shyamaprasad972,06 Jan 2026 11:28:52:937,,13,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:06:45.213,20260105 09:58:58.060,20260106 11:28:52.937,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17009071,Closed,systemuser,14 Nov 2025 11:50:50:913,systemuser,18 Nov 2025 09:11:02:790,systemuser,18 Nov 2025 09:11:02:790,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 11:50:50.913,20251118 09:11:02.790,20251118 09:11:02.790,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17009181,Closed,systemuser,14 Nov 2025 11:54:11:523,systemuser,18 Nov 2025 09:11:11:500,systemuser,18 Nov 2025 09:11:11:500,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 11:54:11.523,20251118 09:11:11.500,20251118 09:11:11.500,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 3.2 Maintenance (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20425827,Closed,systemuser,27 Apr 2026 06:58:00:870,systemuser,27 Apr 2026 06:59:40:830,systemuser,27 Apr 2026 06:59:40:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 06:58:00.870,20260427 06:59:40.830,20260427 06:59:40.833,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17209130,Closed,systemuser,24 Nov 2025 08:01:09:403,systemuser,24 Nov 2025 08:05:24:837,systemuser,24 Nov 2025 08:05:24:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251124 08:01:09.403,20251124 08:05:24.837,20251124 08:05:24.840,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17731113,Closed,systemuser,08 Dec 2025 07:58:36:403,systemuser,08 Dec 2025 07:58:42:790,systemuser,08 Dec 2025 07:58:42:793,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251208 07:58:36.403,20251208 07:58:42.790,20251208 07:58:42.793,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18149017,Closed,systemuser,22 Dec 2025 07:58:27:333,systemuser,22 Dec 2025 07:59:20:983,systemuser,22 Dec 2025 07:59:20:987,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.333,20251222 07:59:20.983,20251222 07:59:20.987,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,18149015,Closed,systemuser,22 Dec 2025 07:58:27:317,systemuser,22 Dec 2025 07:59:20:993,systemuser,22 Dec 2025 07:59:20:993,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.317,20251222 07:59:20.993,20251222 07:59:20.993,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18149016,Closed,systemuser,22 Dec 2025 07:58:27:327,systemuser,22 Dec 2025 07:59:20:997,systemuser,22 Dec 2025 07:59:20:997,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.327,20251222 07:59:20.997,20251222 07:59:20.997,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,18149012,Closed,systemuser,22 Dec 2025 07:58:27:280,systemuser,22 Dec 2025 07:59:20:997,systemuser,22 Dec 2025 07:59:20:997,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.280,20251222 07:59:20.997,20251222 07:59:20.997,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,18149014,Closed,systemuser,22 Dec 2025 07:58:27:307,systemuser,22 Dec 2025 07:59:20:997,systemuser,22 Dec 2025 07:59:20:997,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.307,20251222 07:59:20.997,20251222 07:59:20.997,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18149047,Closed,systemuser,22 Dec 2025 07:59:21:177,systemuser,22 Dec 2025 07:59:25:823,systemuser,22 Dec 2025 07:59:25:830,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:59:21.177,20251222 07:59:25.823,20251222 07:59:25.830,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040003,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Weight,Auto,18149013,Closed,systemuser,22 Dec 2025 07:58:27:293,systemuser,22 Dec 2025 07:59:21:000,systemuser,22 Dec 2025 07:59:21:000,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 07:58:27.293,20251222 07:59:21.000,20251222 07:59:21.000,98,335,335,26,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260421 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19936664,Closed,systemuser,13 Apr 2026 10:17:06:907,systemuser,21 Apr 2026 10:23:54:673,systemuser,21 Apr 2026 10:23:54:840,,8,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260413 10:17:06.907,20260421 10:23:54.673,20260421 10:23:54.840,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933314,Closed,systemuser,20 May 2026 12:09:14:457,,,systemuser,20 May 2026 12:09:28:407,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:09:14.457,,20260520 12:09:28.407,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,18611565,Closed,systemuser,26 Jan 2026 06:45:00:130,,,systemuser,26 Jan 2026 07:36:14:250,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260126 06:45:00.130,,20260126 07:36:14.250,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18136451,Cancelled,Ashwini201,19 Dec 2025 14:52:41:943,,,kminarov1,15 Jan 2026 08:59:00:713,,,,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 14:52:41.943,,20260115 08:59:00.713,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,Is the medical history disease/condition or event still ongoing?,Auto,16928104,Closed,systemuser,11 Nov 2025 15:07:53:720,systemuser,11 Nov 2025 15:08:51:210,systemuser,11 Nov 2025 15:08:51:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 15:07:53.720,20251111 15:08:51.210,20251111 15:08:51.213,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Auto,16928103,Closed,systemuser,11 Nov 2025 15:07:53:703,,11 Nov 2025 15:08:51:267,systemuser,11 Nov 2025 15:08:51:267,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 15:07:53.703,20251111 15:08:51.267,20251111 15:08:51.267,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,DM,17009134,Closed,CoderImport,14 Nov 2025 11:52:09:027,BrezVe1,18 Nov 2025 09:12:45:677,systemuser,18 Nov 2025 09:12:45:813,,4,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. BILATERAL DIAPHRAGMATIC HERNIA and 2. LAPAROSCOPICALLY BILATERAL DIAGPHRAGMATIC HERNIA REPAIR.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 11:52:09.027,20251118 09:12:45.677,20251118 09:12:45.813,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,17057574,Closed,kavya@1510,18 Nov 2025 08:10:32:457,BrezVe1,18 Nov 2025 09:12:19:873,kavya@1510,20 Nov 2025 08:04:43:933,,0,2,"Eligibility: Kindly clarify underlying etiology, other associated signs and symptoms and any investigations done to establish final diagnosis. Kindly also comment subject is clinically stable and meets inclusion criteria #8","etiology unknown, stable",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 08:10:32.457,20251118 09:12:19.873,20251120 08:04:43.933,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,DM,19081322,Closed,SanchariDutta@025,19 Feb 2026 13:40:12:940,EHerman2,24 Feb 2026 07:20:16:300,SanchariDutta@025,10 Mar 2026 14:34:12:357,,5,14,Medical Review I-1943314: Kindly mention the etiology for PAIN SYNDROME IN THE LUMBAR SPINE.,general non specific degenerative process of spine,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260219 13:40:12.940,20260224 07:20:16.300,20260310 14:34:12.357,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18425988,Closed,systemuser,13 Jan 2026 17:01:29:430,systemuser,13 Jan 2026 17:01:57:267,systemuser,13 Jan 2026 17:01:57:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:01:29.430,20260113 17:01:57.267,20260113 17:01:57.270,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16927931,Closed,systemuser,11 Nov 2025 15:00:54:780,systemuser,18 Nov 2025 09:11:21:737,systemuser,18 Nov 2025 09:11:21:737,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 15:00:54.780,20251118 09:11:21.737,20251118 09:11:21.737,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,18246892,Closed,Ashwini201,30 Dec 2025 06:51:27:237,BrezVe1,05 Jan 2026 10:00:51:533,shyamaprasad972,06 Jan 2026 11:18:49:460,,6,1,"DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251230 06:51:27.237,20260105 10:00:51.533,20260106 11:18:49.460,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/N,1,Start Date,Auto,20606593,Closed,systemuser,05 May 2026 06:43:09:783,,,systemuser,06 May 2026 07:32:04:917,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 06:43:09.783,,20260506 07:32:04.917,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,17647022,Closed,systemuser,05 Dec 2025 08:56:15:047,,,systemuser,08 Dec 2025 08:31:35:187,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:56:15.047,,20251208 08:31:35.187,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,18611564,Closed,systemuser,26 Jan 2026 06:45:00:110,,,systemuser,26 Jan 2026 07:35:26:850,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260126 06:45:00.110,,20260126 07:35:26.850,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,Start Date,Auto,19501352,Closed,systemuser,13 Mar 2026 07:38:48:580,,,systemuser,20 Mar 2026 11:35:45:327,,,7,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260313 07:38:48.580,,20260320 11:35:45.327,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.4 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,18716026,Closed,systemuser,02 Feb 2026 08:36:25:027,systemuser,02 Feb 2026 08:36:39:623,systemuser,02 Feb 2026 08:36:39:627,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:36:25.027,20260202 08:36:39.623,20260202 08:36:39.627,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.4 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,18716027,Closed,systemuser,02 Feb 2026 08:36:25:040,systemuser,02 Feb 2026 08:36:39:950,systemuser,02 Feb 2026 08:36:39:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:36:25.040,20260202 08:36:39.950,20260202 08:36:39.950,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18974408,Closed,systemuser,16 Feb 2026 11:50:08:263,systemuser,16 Feb 2026 11:50:13:210,systemuser,16 Feb 2026 11:50:13:210,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 11:50:08.263,20260216 11:50:13.210,20260216 11:50:13.210,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,19522818,Closed,systemuser,16 Mar 2026 07:58:42:147,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.147,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"2. Feeling down, depressed, or hopeless.",Auto,19522819,Closed,systemuser,16 Mar 2026 07:58:42:153,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.153,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,19522820,Closed,systemuser,16 Mar 2026 07:58:42:160,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.160,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,4. Feeling tired or having little energy.,Auto,19522821,Closed,systemuser,16 Mar 2026 07:58:42:163,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.163,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,5. Poor appetite or overeating.,Auto,19522822,Closed,systemuser,16 Mar 2026 07:58:42:170,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.170,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,19522823,Closed,systemuser,16 Mar 2026 07:58:42:173,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.173,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,19522824,Closed,systemuser,16 Mar 2026 07:58:42:180,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.180,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,19522825,Closed,systemuser,16 Mar 2026 07:58:42:187,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.187,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,19522826,Closed,systemuser,16 Mar 2026 07:58:42:193,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.193,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,19522827,Closed,systemuser,16 Mar 2026 07:58:42:200,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.200,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 1.7 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,Was the collection date the same as the visit date?,Auto,19522817,Closed,systemuser,16 Mar 2026 07:58:42:137,systemuser,16 Mar 2026 07:59:24:143,systemuser,16 Mar 2026 07:59:24:143,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 07:58:42.137,20260316 07:59:24.143,20260316 07:59:24.143,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20426536,Closed,systemuser,27 Apr 2026 07:19:30:220,systemuser,27 Apr 2026 07:19:35:360,systemuser,27 Apr 2026 07:19:35:363,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 07:19:30.220,20260427 07:19:35.360,20260427 07:19:35.363,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,18427405,Closed,systemuser,13 Jan 2026 18:55:45:367,systemuser,26 Jan 2026 07:34:05:540,systemuser,26 Jan 2026 07:34:05:540,,13,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 18:55:45.367,20260126 07:34:05.540,20260126 07:34:05.540,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,18174712,Closed,Ashwini201,23 Dec 2025 08:33:14:420,BrezVe1,05 Jan 2026 10:01:40:950,Ashwini201,09 Jan 2026 08:30:35:950,,13,4,"DM: Please verify and update the data on all blank forms of Visit 3 Part 1 Baseline, else clarify.",will be done asap,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 08:33:14.420,20260105 10:01:40.950,20260109 08:30:35.950,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,18368243 (18174712),Closed,Ashwini201,09 Jan 2026 08:30:36:120,BrezVe1,26 Jan 2026 07:33:56:660,shyamaprasad972,28 Jan 2026 10:40:07:423,,17,2,RQ-DM1: Thank you for the response. Please verify and update the data on blanks form once available.,All V3 data entered,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260109 08:30:36.120,20260126 07:33:56.660,20260128 10:40:07.423,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,18426122,Closed,systemuser,13 Jan 2026 17:13:47:840,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:47.840,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,1. Loss of appetite,Auto,18426123,Closed,systemuser,13 Jan 2026 17:13:47:907,systemuser,13 Jan 2026 17:14:38:887,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:47.907,20260113 17:14:38.887,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,2. Nausea - Vomiting,Auto,18426124,Closed,systemuser,13 Jan 2026 17:13:47:940,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:47.940,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,3. Diarrhea,Auto,18426125,Closed,systemuser,13 Jan 2026 17:13:48:003,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.003,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"4. Anxiety, Nervousness",Auto,18426126,Closed,systemuser,13 Jan 2026 17:13:48:050,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.050,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,18426127,Closed,systemuser,13 Jan 2026 17:13:48:107,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.107,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"6. Dysphoric Mood, Depression",Auto,18426128,Closed,systemuser,13 Jan 2026 17:13:48:160,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.160,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,7. Insomnia,Auto,18426129,Closed,systemuser,13 Jan 2026 17:13:48:197,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.197,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,18426130,Closed,systemuser,13 Jan 2026 17:13:48:233,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.233,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,9. Poor Coordination,Auto,18426131,Closed,systemuser,13 Jan 2026 17:13:48:277,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.277,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"10. Restlessness, Agitation",Auto,18426132,Closed,systemuser,13 Jan 2026 17:13:48:313,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.313,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,11. Diaphoresis,Auto,18426133,Closed,systemuser,13 Jan 2026 17:13:48:360,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.360,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,12. Tremor - Tremulousness,Auto,18426134,Closed,systemuser,13 Jan 2026 17:13:48:390,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.390,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,13. Dizziness - Lightheadedness,Auto,18426135,Closed,systemuser,13 Jan 2026 17:13:48:430,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.430,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,14. Headaches,Auto,18426136,Closed,systemuser,13 Jan 2026 17:13:48:453,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.453,20260113 17:14:38.890,20260113 17:14:38.890,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,15. Muscle Aches or Stiffness,Auto,18426137,Closed,systemuser,13 Jan 2026 17:13:48:483,systemuser,13 Jan 2026 17:14:38:890,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.483,20260113 17:14:38.890,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,16. Weakness,Auto,18426138,Closed,systemuser,13 Jan 2026 17:13:48:537,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.537,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"17. Increased acuity for sound, smell, touch or pain",Auto,18426139,Closed,systemuser,13 Jan 2026 17:13:48:603,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.603,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,18. Paresthesias,Auto,18426140,Closed,systemuser,13 Jan 2026 17:13:48:643,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.643,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"19. Difficulty concentrating, remembering",Auto,18426141,Closed,systemuser,13 Jan 2026 17:13:48:650,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.650,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,"20. Depersonalization, Derealization",Auto,18426142,Closed,systemuser,13 Jan 2026 17:13:48:670,systemuser,13 Jan 2026 17:14:38:893,systemuser,13 Jan 2026 17:14:38:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 17:13:48.670,20260113 17:14:38.893,20260113 17:14:38.893,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,1. My sleep quality was,Auto,17646785,Closed,systemuser,05 Dec 2025 08:48:40:420,systemuser,05 Dec 2025 08:50:05:223,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.420,20251205 08:50:05.223,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,2. My sleep was refreshing,Auto,17646786,Closed,systemuser,05 Dec 2025 08:48:40:457,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.457,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,3. I had a problem with my sleep,Auto,17646787,Closed,systemuser,05 Dec 2025 08:48:40:483,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.483,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,4. I had difficulty falling asleep,Auto,17646788,Closed,systemuser,05 Dec 2025 08:48:40:540,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.540,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,5. My sleep was restless,Auto,17646789,Closed,systemuser,05 Dec 2025 08:48:40:580,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.580,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,6. I tried hard to get to sleep,Auto,17646790,Closed,systemuser,05 Dec 2025 08:48:40:610,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.610,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,7. I worried about not being able to fall asleep,Auto,17646791,Closed,systemuser,05 Dec 2025 08:48:40:617,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.617,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,8. I was satisfied with my sleep,Auto,17646792,Closed,systemuser,05 Dec 2025 08:48:40:620,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.620,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,Was the collection date the same as the visit date?,Auto,17646784,Closed,systemuser,05 Dec 2025 08:48:40:360,systemuser,05 Dec 2025 08:50:05:227,systemuser,05 Dec 2025 08:50:05:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:48:40.360,20251205 08:50:05.227,20251205 08:50:05.227,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040004,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18359435,Closed,systemuser,08 Jan 2026 16:31:16:867,systemuser,26 Jan 2026 07:34:11:793,systemuser,26 Jan 2026 07:34:11:797,,18,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260108 16:31:16.867,20260126 07:34:11.793,20260126 07:34:11.797,98,335,335,21,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,Is the adverse event still ongoing?,DM,19788571,Closed,JThoma858,01 Apr 2026 06:28:24:477,BrezVe1,01 Apr 2026 08:19:58:773,JThoma858,02 Apr 2026 06:47:14:017,,0,1,Medical Review I-3115319: Please clarify if the event is still ongoing.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 06:28:24.477,20260401 08:19:58.773,20260402 06:47:14.017,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,Outcome,Auto,19224943,Closed,systemuser,02 Mar 2026 06:46:53:450,systemuser,02 Mar 2026 06:48:16:157,systemuser,02 Mar 2026 06:48:16:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 06:46:53.450,20260302 06:48:16.157,20260302 06:48:16.160,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,Relationship to Study Treatment,DM,19815411,Closed,Juhita@ksha4,02 Apr 2026 13:36:04:210,BrezVe1,20 Apr 2026 11:26:32:690,Juhita@ksha4,22 Apr 2026 08:18:25:260,,18,2,Medical Review I-3115728: Kindly clarify rationality to consider AE to be related to study drug.,PI decision,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260402 13:36:04.210,20260420 11:26:32.690,20260422 08:18:25.260,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,Is the adverse event serious?,Auto,19224946,Closed,systemuser,02 Mar 2026 06:46:53:470,systemuser,02 Mar 2026 06:48:16:160,systemuser,02 Mar 2026 06:48:16:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 06:46:53.470,20260302 06:48:16.160,20260302 06:48:16.160,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,What is the adverse event term?,DM,19788504,Closed,JThoma858,01 Apr 2026 06:24:44:720,BrezVe1,01 Apr 2026 08:13:19:773,JThoma858,02 Apr 2026 05:48:57:250,,0,1,"Medical Review I-3115321 : Could you please confirm whether the psychomotor retardation was caused by increased somnolence? Kindly consider which term best describes the event. Otherwise, clarify.",Term PSYCHOMOTORIC RETARDATION DURING MORNING correct according to PI,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 06:24:44.720,20260401 08:13:19.773,20260402 05:48:57.250,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,What is the adverse event term?,DM,19788518,Closed,JThoma858,01 Apr 2026 06:26:50:533,BrezVe1,01 Apr 2026 08:12:47:600,JThoma858,02 Apr 2026 05:49:55:723,,0,1,"Medical Review  I-3115320 : Could you please specify how long during the day the participant continued to experience retardation? Otherwise, clarify.",not specified,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 06:26:50.533,20260401 08:12:47.600,20260402 05:49:55.723,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,2,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,18655963,Closed,systemuser,28 Jan 2026 11:58:29:513,EHerman2,28 Jan 2026 11:59:19:170,Ashwini201,29 Jan 2026 08:00:36:347,,0,1,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 11:58:29.513,20260128 11:59:19.170,20260129 08:00:36.347,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,2,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,DM,18670013,Closed,Ashwini201,29 Jan 2026 08:00:50:960,EHerman2,03 Feb 2026 06:48:52:060,Ashwini201,04 Feb 2026 07:51:21:887,,5,1,"RQ-DM1: Thank you for the response. However, the field 'Was the medication/therapy taken prior to the study?' is still not updated. Kindly verify and update the data in the field.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 08:00:50.960,20260203 06:48:52.060,20260204 07:51:21.887,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,18655985,Closed,systemuser,28 Jan 2026 12:00:42:960,systemuser,28 Jan 2026 12:02:11:950,systemuser,28 Jan 2026 12:02:11:950,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 12:00:42.960,20260128 12:02:11.950,20260128 12:02:11.950,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933321,Closed,systemuser,20 May 2026 12:10:02:133,,,systemuser,20 May 2026 12:10:14:603,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:10:02.133,,20260520 12:10:14.603,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19225539,Closed,systemuser,02 Mar 2026 07:24:56:597,,,systemuser,20 Apr 2026 11:25:05:500,,,49,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 07:24:56.597,,20260420 11:25:05.500,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal Ideation1. Wish to be DeadLifetime,Auto,18654597,Closed,systemuser,28 Jan 2026 10:46:03:283,systemuser,28 Jan 2026 10:52:16:527,systemuser,28 Jan 2026 10:52:16:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.283,20260128 10:52:16.527,20260128 10:52:16.530,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 6 Months,Auto,18654598,Closed,systemuser,28 Jan 2026 10:46:03:290,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.290,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,2. Non-Specific Active Suicidal ThoughtsLifetime,Auto,18654599,Closed,systemuser,28 Jan 2026 10:46:03:300,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.300,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 6 Months,Auto,18654600,Closed,systemuser,28 Jan 2026 10:46:03:307,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.307,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal BehaviorActual AttemptLifetime,Auto,18654601,Closed,systemuser,28 Jan 2026 10:46:03:353,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.353,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654602,Closed,systemuser,28 Jan 2026 10:46:03:360,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.360,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?Lifetime,Auto,18654603,Closed,systemuser,28 Jan 2026 10:46:03:380,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.380,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654604,Closed,systemuser,28 Jan 2026 10:46:03:390,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.390,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Interrupted AttemptLifetime,Auto,18654605,Closed,systemuser,28 Jan 2026 10:46:03:400,systemuser,28 Jan 2026 10:53:26:423,systemuser,28 Jan 2026 10:53:26:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.400,20260128 10:53:26.423,20260128 10:53:26.427,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654606,Closed,systemuser,28 Jan 2026 10:46:03:407,systemuser,28 Jan 2026 10:53:26:427,systemuser,28 Jan 2026 10:53:26:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.407,20260128 10:53:26.427,20260128 10:53:26.427,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Aborted AttemptLifetime,Auto,18654607,Closed,systemuser,28 Jan 2026 10:46:03:420,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.420,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654608,Closed,systemuser,28 Jan 2026 10:46:03:430,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.430,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Preparatory Acts or BehaviorLifetime,Auto,18654609,Closed,systemuser,28 Jan 2026 10:46:03:440,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.440,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654610,Closed,systemuser,28 Jan 2026 10:46:03:450,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.450,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal BehaviorLifetime,Auto,18654611,Closed,systemuser,28 Jan 2026 10:46:03:460,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.460,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18654612,Closed,systemuser,28 Jan 2026 10:46:03:470,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.470,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Rater's Initials,Auto,18654596,Closed,systemuser,28 Jan 2026 10:46:03:280,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.280,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Was the collection date the same as the visit date?,Auto,18654595,Closed,systemuser,28 Jan 2026 10:46:03:263,systemuser,28 Jan 2026 10:52:16:563,systemuser,28 Jan 2026 10:52:16:563,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:46:03.263,20260128 10:52:16.563,20260128 10:52:16.563,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,18708650,Cancelled,Rajani_S_N1,31 Jan 2026 18:02:10:460,,,Rajani_S_N1,03 Feb 2026 13:39:13:473,,,,ELigibility: Kindly update AE form with details Yes / no  ,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260131 18:02:10.460,,20260203 13:39:13.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18708661,Closed,Rajani_S_N1,31 Jan 2026 18:11:22:683,EHerman2,03 Feb 2026 06:47:22:130,Rajani_S_N1,03 Feb 2026 13:38:11:480,,3,0,Eligibility: Kindly comment on the clinical stability of the medical condition and severity,"chronic condition with mild severity, not present all the time, present episodically",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260131 18:11:22.683,20260203 06:47:22.130,20260203 13:38:11.480,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Mini-Mental State Examination,0/0/N,,Rater's Initials,Auto,18655622,Closed,systemuser,28 Jan 2026 11:40:20:817,systemuser,28 Jan 2026 11:44:36:897,systemuser,28 Jan 2026 11:44:36:900,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 11:40:20.817,20260128 11:44:36.897,20260128 11:44:36.900,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Mini-Mental State Examination,0/0/N,,Total Score,Auto,18655623,Closed,systemuser,28 Jan 2026 11:40:20:823,systemuser,28 Jan 2026 11:44:36:900,systemuser,28 Jan 2026 11:44:36:900,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 11:40:20.823,20260128 11:44:36.900,20260128 11:44:36.900,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Mini-Mental State Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18655621,Closed,systemuser,28 Jan 2026 11:40:20:803,systemuser,28 Jan 2026 11:44:36:900,systemuser,28 Jan 2026 11:44:36:900,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 11:40:20.803,20260128 11:44:36.900,20260128 11:44:36.900,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Neurologic Examination,0/0/N,,Date of Assessment,Auto,19111043,Closed,systemuser,23 Feb 2026 07:47:55:310,systemuser,23 Feb 2026 07:49:10:937,systemuser,23 Feb 2026 07:49:10:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:47:55.310,20260223 07:49:10.937,20260223 07:49:10.937,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19110929,Closed,systemuser,23 Feb 2026 07:37:44:573,systemuser,23 Feb 2026 07:38:02:840,systemuser,23 Feb 2026 07:38:02:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:37:44.573,20260223 07:38:02.840,20260223 07:38:02.840,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,SIGH-D-17,0/0/N,,Collection Date,Auto,18703176,Closed,systemuser,30 Jan 2026 15:57:22:960,systemuser,30 Jan 2026 15:57:44:787,systemuser,30 Jan 2026 15:57:44:790,,0,0,"If Yes, was the collection date the same as the visit date? Is entered as ""No"". However the Collection date entered is same as the Date of visit. Please correct.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260130 15:57:22.960,20260130 15:57:44.787,20260130 15:57:44.790,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18654047,Closed,systemuser,28 Jan 2026 10:24:37:333,systemuser,28 Jan 2026 10:25:24:680,systemuser,28 Jan 2026 10:25:24:683,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:24:37.333,20260128 10:25:24.680,20260128 10:25:24.683,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18654076,Closed,systemuser,28 Jan 2026 10:25:25:290,systemuser,28 Jan 2026 10:25:50:847,systemuser,28 Jan 2026 10:25:50:850,,0,0,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:25:25.290,20260128 10:25:50.847,20260128 10:25:50.850,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Pulse,Auto,18654045,Closed,systemuser,28 Jan 2026 10:24:37:313,systemuser,28 Jan 2026 10:25:24:730,systemuser,28 Jan 2026 10:25:24:730,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:24:37.313,20260128 10:25:24.730,20260128 10:25:24.730,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18654046,Closed,systemuser,28 Jan 2026 10:24:37:323,systemuser,28 Jan 2026 10:25:24:750,systemuser,28 Jan 2026 10:25:24:750,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:24:37.323,20260128 10:25:24.750,20260128 10:25:24.750,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature,Auto,18654044,Closed,systemuser,28 Jan 2026 10:24:37:300,systemuser,28 Jan 2026 10:25:24:750,systemuser,28 Jan 2026 10:25:24:750,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260128 10:24:37.300,20260128 10:25:24.750,20260128 10:25:24.750,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,19111069,Closed,systemuser,23 Feb 2026 07:50:15:153,systemuser,23 Feb 2026 07:50:51:857,systemuser,23 Feb 2026 07:50:51:860,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:50:15.153,20260223 07:50:51.857,20260223 07:50:51.860,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,19111068,Closed,systemuser,23 Feb 2026 07:50:08:937,systemuser,23 Feb 2026 07:50:15:120,systemuser,23 Feb 2026 07:50:15:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:50:08.937,20260223 07:50:15.120,20260223 07:50:15.123,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,19095586,Closed,systemuser,20 Feb 2026 11:11:16:217,,,systemuser,23 Feb 2026 08:35:56:117,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 11:11:16.217,,20260223 08:35:56.117,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,19866145,Closed,systemuser,08 Apr 2026 10:35:41:853,,,systemuser,20 Apr 2026 11:15:17:657,,,12,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:35:41.853,,20260420 11:15:17.657,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,1. How strong is your sex drive?,Auto,19111322,Closed,systemuser,23 Feb 2026 08:09:35:117,systemuser,23 Feb 2026 08:10:01:447,systemuser,23 Feb 2026 08:10:01:447,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.117,20260223 08:10:01.447,20260223 08:10:01.447,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,2. How easily are you sexually aroused (turned on)?,Auto,19111323,Closed,systemuser,23 Feb 2026 08:09:35:123,systemuser,23 Feb 2026 08:10:01:447,systemuser,23 Feb 2026 08:10:01:447,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.123,20260223 08:10:01.447,20260223 08:10:01.447,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,3. How easily does your vagina become moist or wet during sex?,Auto,19111324,Closed,systemuser,23 Feb 2026 08:09:35:130,systemuser,23 Feb 2026 08:10:01:447,systemuser,23 Feb 2026 08:10:01:447,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.130,20260223 08:10:01.447,20260223 08:10:01.447,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,4. How easily can you reach an orgasm?,Auto,19111325,Closed,systemuser,23 Feb 2026 08:09:35:137,systemuser,23 Feb 2026 08:10:01:447,systemuser,23 Feb 2026 08:10:01:447,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.137,20260223 08:10:01.447,20260223 08:10:01.447,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,5. Are your orgasms satisfying?,Auto,19111326,Closed,systemuser,23 Feb 2026 08:09:35:143,systemuser,23 Feb 2026 08:10:01:450,systemuser,23 Feb 2026 08:10:01:450,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.143,20260223 08:10:01.450,20260223 08:10:01.450,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,Was the collection date the same as the visit date?,Auto,19111321,Closed,systemuser,23 Feb 2026 08:09:35:103,systemuser,23 Feb 2026 08:10:01:450,systemuser,23 Feb 2026 08:10:01:450,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:09:35.103,20260223 08:10:01.450,20260223 08:10:01.450,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Ideation1. Wish to be Dead,Auto,19111468,Closed,systemuser,23 Feb 2026 08:15:37:320,systemuser,23 Feb 2026 08:16:43:813,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.320,20260223 08:16:43.813,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,2. Non-Specific Active Suicidal Thoughts,Auto,19111469,Closed,systemuser,23 Feb 2026 08:15:37:327,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.327,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal BehaviorActual Attempt,Auto,19111470,Closed,systemuser,23 Feb 2026 08:15:37:350,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.350,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,19111471,Closed,systemuser,23 Feb 2026 08:15:37:357,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.357,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Interrupted Attempt,Auto,19111472,Closed,systemuser,23 Feb 2026 08:15:37:360,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.360,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Aborted Attempt,Auto,19111473,Closed,systemuser,23 Feb 2026 08:15:37:370,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.370,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Preparatory Acts or Behavior,Auto,19111474,Closed,systemuser,23 Feb 2026 08:15:37:373,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.373,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Behavior,Auto,19111475,Closed,systemuser,23 Feb 2026 08:15:37:380,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.380,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicide,Auto,19111476,Closed,systemuser,23 Feb 2026 08:15:37:390,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.390,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Rater's Initials,Auto,19111467,Closed,systemuser,23 Feb 2026 08:15:37:317,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.317,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Was the collection date the same as the visit date?,Auto,19111466,Closed,systemuser,23 Feb 2026 08:15:37:310,systemuser,23 Feb 2026 08:16:43:817,systemuser,23 Feb 2026 08:16:43:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:15:37.310,20260223 08:16:43.817,20260223 08:16:43.817,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,19111541,Closed,systemuser,23 Feb 2026 08:21:18:697,systemuser,23 Feb 2026 08:21:42:297,systemuser,23 Feb 2026 08:21:42:300,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:21:18.697,20260223 08:21:42.297,20260223 08:21:42.300,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Patient Global Impression of Severity - Insomnia,0/0/N,,"Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.",Auto,19111292,Closed,systemuser,23 Feb 2026 08:08:27:373,systemuser,23 Feb 2026 08:08:41:683,systemuser,23 Feb 2026 08:08:41:687,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:08:27.373,20260223 08:08:41.683,20260223 08:08:41.687,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.",Auto,19111291,Closed,systemuser,23 Feb 2026 08:08:27:370,systemuser,23 Feb 2026 08:08:41:687,systemuser,23 Feb 2026 08:08:41:687,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:08:27.370,20260223 08:08:41.687,20260223 08:08:41.687,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your sleep problems?",Auto,19111293,Closed,systemuser,23 Feb 2026 08:08:27:380,systemuser,23 Feb 2026 08:08:41:687,systemuser,23 Feb 2026 08:08:41:687,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:08:27.380,20260223 08:08:41.687,20260223 08:08:41.687,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Patient Global Impression of Severity - Insomnia,0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,19111290,Closed,systemuser,23 Feb 2026 08:08:27:360,systemuser,23 Feb 2026 08:08:41:687,systemuser,23 Feb 2026 08:08:41:687,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:08:27.360,20260223 08:08:41.687,20260223 08:08:41.687,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19111238,Closed,systemuser,23 Feb 2026 08:05:32:270,systemuser,23 Feb 2026 08:05:41:303,systemuser,23 Feb 2026 08:05:41:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 08:05:32.270,20260223 08:05:41.303,20260223 08:05:41.307,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,1. Reported Sadness,Auto,19095216,Closed,systemuser,20 Feb 2026 10:42:08:240,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.240,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,2. Apparent Sadness,Auto,19095217,Closed,systemuser,20 Feb 2026 10:42:08:243,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.243,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,3. Inner Tension,Auto,19095218,Closed,systemuser,20 Feb 2026 10:42:08:250,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.250,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,4. Reduced Sleep,Auto,19095219,Closed,systemuser,20 Feb 2026 10:42:08:257,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.257,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,5. Reduced Appetite,Auto,19095220,Closed,systemuser,20 Feb 2026 10:42:08:260,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.260,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,6. Concentration Difficulties,Auto,19095221,Closed,systemuser,20 Feb 2026 10:42:08:267,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.267,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,7. Lassitude,Auto,19095222,Closed,systemuser,20 Feb 2026 10:42:08:270,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.270,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,8. Inability to Feel,Auto,19095223,Closed,systemuser,20 Feb 2026 10:42:08:277,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.277,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,9. Pessimistic Thoughts,Auto,19095224,Closed,systemuser,20 Feb 2026 10:42:08:280,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.280,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,19095225,Closed,systemuser,20 Feb 2026 10:42:08:287,systemuser,20 Feb 2026 10:43:16:473,systemuser,20 Feb 2026 10:43:16:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.287,20260220 10:43:16.473,20260220 10:43:16.473,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,19095226,Closed,systemuser,20 Feb 2026 10:42:08:290,systemuser,20 Feb 2026 10:43:16:730,systemuser,20 Feb 2026 10:43:16:730,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.290,20260220 10:43:16.730,20260220 10:43:16.730,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Rater's Initials,Auto,19095215,Closed,systemuser,20 Feb 2026 10:42:08:233,systemuser,20 Feb 2026 10:43:16:490,systemuser,20 Feb 2026 10:43:16:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.233,20260220 10:43:16.490,20260220 10:43:16.490,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Was the collection date the same as the visit date?,Auto,19095214,Closed,systemuser,20 Feb 2026 10:42:08:223,systemuser,20 Feb 2026 10:43:16:490,systemuser,20 Feb 2026 10:43:16:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260220 10:42:08.223,20260220 10:43:16.490,20260220 10:43:16.490,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Body Mass Index,Auto,19111129,Closed,systemuser,23 Feb 2026 07:59:15:197,systemuser,23 Feb 2026 08:00:50:210,systemuser,23 Feb 2026 08:00:50:210,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.197,20260223 08:00:50.210,20260223 08:00:50.210,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,19111133,Closed,systemuser,23 Feb 2026 07:59:15:220,systemuser,23 Feb 2026 08:04:09:543,systemuser,23 Feb 2026 08:04:09:543,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.220,20260223 08:04:09.543,20260223 08:04:09.543,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Pulse,Auto,19111131,Closed,systemuser,23 Feb 2026 07:59:15:210,systemuser,23 Feb 2026 08:04:09:553,systemuser,23 Feb 2026 08:04:09:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.210,20260223 08:04:09.553,20260223 08:04:09.553,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,19111132,Closed,systemuser,23 Feb 2026 07:59:15:217,systemuser,23 Feb 2026 08:04:09:557,systemuser,23 Feb 2026 08:04:09:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.217,20260223 08:04:09.557,20260223 08:04:09.557,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,19111127,Closed,systemuser,23 Feb 2026 07:59:15:183,systemuser,23 Feb 2026 08:00:50:213,systemuser,23 Feb 2026 08:00:50:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.183,20260223 08:00:50.213,20260223 08:00:50.213,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature,Auto,19111130,Closed,systemuser,23 Feb 2026 07:59:15:203,systemuser,23 Feb 2026 08:04:09:560,systemuser,23 Feb 2026 08:04:09:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.203,20260223 08:04:09.560,20260223 08:04:09.560,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Weight,Auto,19111128,Closed,systemuser,23 Feb 2026 07:59:15:193,systemuser,23 Feb 2026 08:00:50:213,systemuser,23 Feb 2026 08:00:50:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260223 07:59:15.193,20260223 08:00:50.213,20260223 08:00:50.213,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19826791,Closed,Juhita@ksha4,03 Apr 2026 16:29:36:310,BrezVe1,20 Apr 2026 11:17:23:113,Juhita@ksha4,22 Apr 2026 08:47:01:863,,17,2,DM: Please verify and updated the visit 8 part 1.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260403 16:29:36.310,20260420 11:17:23.113,20260422 08:47:01.863,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,19758826,Closed,systemuser,30 Mar 2026 12:30:07:610,systemuser,30 Mar 2026 12:32:35:927,systemuser,30 Mar 2026 12:32:35:930,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:30:07.610,20260330 12:32:35.927,20260330 12:32:35.930,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,19758823,Closed,systemuser,30 Mar 2026 12:30:07:593,systemuser,30 Mar 2026 12:32:35:937,systemuser,30 Mar 2026 12:32:35:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:30:07.593,20260330 12:32:35.937,20260330 12:32:35.937,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,19758824,Closed,systemuser,30 Mar 2026 12:30:07:600,systemuser,30 Mar 2026 12:32:35:943,systemuser,30 Mar 2026 12:32:35:943,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:30:07.600,20260330 12:32:35.943,20260330 12:32:35.943,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,19758820,Closed,systemuser,30 Mar 2026 12:30:07:570,systemuser,30 Mar 2026 12:32:35:943,systemuser,30 Mar 2026 12:32:35:943,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:30:07.570,20260330 12:32:35.943,20260330 12:32:35.943,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,19758821,Closed,systemuser,30 Mar 2026 12:30:07:587,systemuser,30 Mar 2026 12:32:35:943,systemuser,30 Mar 2026 12:32:35:943,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:30:07.587,20260330 12:32:35.943,20260330 12:32:35.943,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,1. How strong is your sex drive?,Auto,19866306,Closed,systemuser,08 Apr 2026 10:39:35:260,systemuser,08 Apr 2026 10:41:00:107,systemuser,08 Apr 2026 10:41:00:107,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.260,20260408 10:41:00.107,20260408 10:41:00.107,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,2. How easily are you sexually aroused (turned on)?,Auto,19866307,Closed,systemuser,08 Apr 2026 10:39:35:270,systemuser,08 Apr 2026 10:41:00:107,systemuser,08 Apr 2026 10:41:00:107,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.270,20260408 10:41:00.107,20260408 10:41:00.107,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,3. How easily does your vagina become moist or wet during sex?,Auto,19866308,Closed,systemuser,08 Apr 2026 10:39:35:277,systemuser,08 Apr 2026 10:41:00:107,systemuser,08 Apr 2026 10:41:00:107,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.277,20260408 10:41:00.107,20260408 10:41:00.107,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,4. How easily can you reach an orgasm?,Auto,19866309,Closed,systemuser,08 Apr 2026 10:39:35:283,systemuser,08 Apr 2026 10:41:00:110,systemuser,08 Apr 2026 10:41:00:110,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.283,20260408 10:41:00.110,20260408 10:41:00.110,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,5. Are your orgasms satisfying?,Auto,19866310,Closed,systemuser,08 Apr 2026 10:39:35:293,systemuser,08 Apr 2026 10:41:00:110,systemuser,08 Apr 2026 10:41:00:110,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.293,20260408 10:41:00.110,20260408 10:41:00.110,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Arizona Sexual Experiences Scale-Female,0/0/N,,Was the collection date the same as the visit date?,Auto,19866305,Closed,systemuser,08 Apr 2026 10:39:35:247,systemuser,08 Apr 2026 10:41:00:110,systemuser,08 Apr 2026 10:41:00:110,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:39:35.247,20260408 10:41:00.110,20260408 10:41:00.110,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Mobility,Auto,19888919,Closed,systemuser,09 Apr 2026 10:43:01:103,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.103,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Self-Care,Auto,19888920,Closed,systemuser,09 Apr 2026 10:43:01:113,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.113,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Usual Activities,Auto,19888921,Closed,systemuser,09 Apr 2026 10:43:01:120,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.120,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Pain/Discomfort,Auto,19888922,Closed,systemuser,09 Apr 2026 10:43:01:127,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.127,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Anxiety/Depression,Auto,19888923,Closed,systemuser,09 Apr 2026 10:43:01:133,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.133,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Your health today,Auto,19888924,Closed,systemuser,09 Apr 2026 10:43:01:140,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.140,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Was the collection date the same as the visit date?,Auto,19888918,Closed,systemuser,09 Apr 2026 10:43:01:090,systemuser,09 Apr 2026 10:44:05:370,systemuser,09 Apr 2026 10:44:05:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:43:01.090,20260409 10:44:05.370,20260409 10:44:05.370,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,19889091,Closed,systemuser,09 Apr 2026 10:50:52:147,systemuser,20 Apr 2026 11:16:28:840,systemuser,20 Apr 2026 11:16:28:843,,11,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:50:52.147,20260420 11:16:28.840,20260420 11:16:28.843,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.",Auto,19888942,Closed,systemuser,09 Apr 2026 10:45:16:040,systemuser,09 Apr 2026 10:46:10:640,systemuser,09 Apr 2026 10:46:10:643,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:45:16.040,20260409 10:46:10.640,20260409 10:46:10.643,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.",Auto,19888941,Closed,systemuser,09 Apr 2026 10:45:16:030,systemuser,09 Apr 2026 10:46:10:643,systemuser,09 Apr 2026 10:46:10:643,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:45:16.030,20260409 10:46:10.643,20260409 10:46:10.643,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your sleep problems?",Auto,19888943,Closed,systemuser,09 Apr 2026 10:45:16:047,systemuser,09 Apr 2026 10:46:10:643,systemuser,09 Apr 2026 10:46:10:643,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:45:16.047,20260409 10:46:10.643,20260409 10:46:10.643,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,19888940,Closed,systemuser,09 Apr 2026 10:45:16:020,systemuser,09 Apr 2026 10:46:10:643,systemuser,09 Apr 2026 10:46:10:643,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:45:16.020,20260409 10:46:10.643,20260409 10:46:10.643,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19866258,Closed,systemuser,08 Apr 2026 10:38:23:520,systemuser,08 Apr 2026 10:38:33:053,systemuser,08 Apr 2026 10:38:33:057,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:38:23.520,20260408 10:38:33.053,20260408 10:38:33.057,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,1. Loss of appetite,Auto,19889270,Closed,systemuser,09 Apr 2026 10:53:38:547,systemuser,09 Apr 2026 10:54:51:480,systemuser,09 Apr 2026 10:54:51:480,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.547,20260409 10:54:51.480,20260409 10:54:51.480,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,2. Nausea - Vomiting,Auto,19889271,Closed,systemuser,09 Apr 2026 10:53:38:557,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.557,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,3. Diarrhea,Auto,19889272,Closed,systemuser,09 Apr 2026 10:53:38:567,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.567,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"4. Anxiety, Nervousness",Auto,19889273,Closed,systemuser,09 Apr 2026 10:53:38:573,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.573,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,19889274,Closed,systemuser,09 Apr 2026 10:53:38:583,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.583,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"6. Dysphoric Mood, Depression",Auto,19889275,Closed,systemuser,09 Apr 2026 10:53:38:590,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.590,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,7. Insomnia,Auto,19889276,Closed,systemuser,09 Apr 2026 10:53:38:600,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.600,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,19889277,Closed,systemuser,09 Apr 2026 10:53:38:610,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.610,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,9. Poor Coordination,Auto,19889278,Closed,systemuser,09 Apr 2026 10:53:38:617,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.617,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"10. Restlessness, Agitation",Auto,19889279,Closed,systemuser,09 Apr 2026 10:53:38:627,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.627,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,11. Diaphoresis,Auto,19889280,Closed,systemuser,09 Apr 2026 10:53:38:633,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.633,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,12. Tremor - Tremulousness,Auto,19889281,Closed,systemuser,09 Apr 2026 10:53:38:640,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.640,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,13. Dizziness - Lightheadedness,Auto,19889282,Closed,systemuser,09 Apr 2026 10:53:38:650,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.650,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,14. Headaches,Auto,19889283,Closed,systemuser,09 Apr 2026 10:53:38:657,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.657,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,15. Muscle Aches or Stiffness,Auto,19889284,Closed,systemuser,09 Apr 2026 10:53:38:663,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.663,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,16. Weakness,Auto,19889285,Closed,systemuser,09 Apr 2026 10:53:38:673,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.673,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"17. Increased acuity for sound, smell, touch or pain",Auto,19889286,Closed,systemuser,09 Apr 2026 10:53:38:680,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.680,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,18. Paresthesias,Auto,19889287,Closed,systemuser,09 Apr 2026 10:53:38:683,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.683,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"19. Difficulty concentrating, remembering",Auto,19889288,Closed,systemuser,09 Apr 2026 10:53:38:690,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.690,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"20. Depersonalization, Derealization",Auto,19889289,Closed,systemuser,09 Apr 2026 10:53:38:700,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.700,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040005,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,19889269,Closed,systemuser,09 Apr 2026 10:53:38:533,systemuser,09 Apr 2026 10:54:51:483,systemuser,09 Apr 2026 10:54:51:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:53:38.533,20260409 10:54:51.483,20260409 10:54:51.483,98,335,335,30,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,18724963,Closed,systemuser,02 Feb 2026 15:30:16:610,systemuser,02 Feb 2026 15:30:57:317,systemuser,02 Feb 2026 15:30:57:320,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 15:30:16.610,20260202 15:30:57.317,20260202 15:30:57.320,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Dose Form,DM,19831711,Closed,Juhita@ksha4,06 Apr 2026 07:45:28:657,BrezVe1,20 Apr 2026 11:29:26:733,Juhita@ksha4,22 Apr 2026 08:20:01:520,,14,2,Medical Review I-3115960: Kindly update dose form to implant,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260406 07:45:28.657,20260420 11:29:26.733,20260422 08:20:01.520,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933410,Closed,systemuser,20 May 2026 12:11:52:903,,,systemuser,20 May 2026 12:12:07:250,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:11:52.903,,20260520 12:12:07.250,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,1,Ongoing,Site from Medical Reviewer,19780205,Closed,ewajs1,31 Mar 2026 14:58:18:067,BrezVe1,01 Apr 2026 08:17:44:593,ewajs1,22 Apr 2026 09:49:46:110,,1,21,Did the participant had menstrual period after January? ,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260331 14:58:18.067,20260401 08:17:44.593,20260422 09:49:46.110,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,1,Ongoing,Site from Medical Reviewer,19780237,Closed,ewajs1,31 Mar 2026 14:58:49:267,BrezVe1,01 Apr 2026 08:18:06:720,ewajs1,22 Apr 2026 09:49:49:640,,1,21,Did the participant menstruated regularly prior to the study even if they had a hormonal IUD?,regular ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260331 14:58:49.267,20260401 08:18:06.720,20260422 09:49:49.640,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19910694,Closed,systemuser,10 Apr 2026 11:11:31:410,,,systemuser,20 Apr 2026 11:38:19:350,,,10,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260410 11:11:31.410,,20260420 11:38:19.350,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,19523574,Closed,Ashwini201,16 Mar 2026 08:23:15:543,BrezVe1,23 Mar 2026 13:24:51:430,Ashwini201,25 Mar 2026 08:23:19:487,,7,2,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 08:23:15.543,20260323 13:24:51.430,20260325 08:23:19.487,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,DM,18899111,Closed,CoderImport,12 Feb 2026 06:28:18:150,BrezVe1,16 Feb 2026 12:32:13:037,systemuser,16 Feb 2026 12:32:13:243,,4,0,"CODING:  The verbatim ""APPENDECTOMIA"" in the verbatim term ""APPENDECTOMIA FOR APPENDICITIS"" is not reported in English. Please translate it in English and update the Medical history name field accordingly.Thank you.",will be done but please unfreeze lgline 5 for data entry,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 06:28:18.150,20260216 12:32:13.037,20260216 12:32:13.243,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,DM,18789150,Closed,CoderImport,05 Feb 2026 13:57:27:370,BrezVe1,09 Feb 2026 08:41:25:993,systemuser,09 Feb 2026 08:41:26:107,,4,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON THE LEFT OVARY and 2. UNILATERAL OOPHORECTOMY . Thank you.,please unfreeze logline 5 to enter the procedure,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 13:57:27.370,20260209 08:41:25.993,20260209 08:41:26.107,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18804188,Closed,Rajani_S_N1,06 Feb 2026 09:12:57:993,BrezVe1,09 Feb 2026 08:41:43:683,Rajani_S_N1,09 Feb 2026 11:08:45:110,,3,0,Eliibility: Kindly mention the etiology and clarify if malignant,not specified as malignant,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260206 09:12:57.993,20260209 08:41:43.683,20260209 11:08:45.110,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",Auto,18724469,Closed,systemuser,02 Feb 2026 15:06:41:680,systemuser,02 Feb 2026 15:40:34:157,systemuser,02 Feb 2026 15:40:34:157,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 15:06:41.680,20260202 15:40:34.157,20260202 15:40:34.157,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18724356,Closed,systemuser,02 Feb 2026 15:00:08:523,systemuser,02 Feb 2026 15:00:25:190,systemuser,02 Feb 2026 15:00:25:197,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 15:00:08.523,20260202 15:00:25.190,20260202 15:00:25.197,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,1,Assessment Completed?,DM,19449854,Closed,Juhita@ksha4,10 Mar 2026 16:06:26:983,gnovotna@email.cz2,20 Mar 2026 11:37:45:100,Juhita@ksha4,20 Mar 2026 14:12:01:263,,10,0,ECOA: Please verify and update the data for the field &quot;Assessment Completed?&quot;,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 16:06:26.983,20260320 11:37:45.100,20260320 14:12:01.263,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,19619883,Closed,systemuser,20 Mar 2026 11:38:02:817,systemuser,20 Mar 2026 11:39:25:677,systemuser,20 Mar 2026 11:39:25:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260320 11:38:02.817,20260320 11:39:25.677,20260320 11:39:25.677,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19501289,Closed,Ashwini201,13 Mar 2026 07:34:17:357,gnovotna@email.cz2,20 Mar 2026 11:41:06:517,shyamaprasad972,23 Mar 2026 08:47:54:080,,7,3,"DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260313 07:34:17.357,20260320 11:41:06.517,20260323 08:47:54.080,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,DM,20108885,Closed,Juhita@ksha4,22 Apr 2026 10:26:11:037,BrezVe1,22 Apr 2026 12:44:05:667,Juhita@ksha4,24 Apr 2026 08:54:53:213,,0,2,Medical Review I-5159256: Please provide end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 10:26:11.037,20260422 12:44:05.667,20260424 08:54:53.213,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,19214180,Closed,systemuser,27 Feb 2026 12:30:12:993,,,systemuser,09 Mar 2026 10:21:03:117,,,10,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 12:30:12.993,,20260309 10:21:03.117,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,19910693,Closed,systemuser,10 Apr 2026 11:11:31:393,,,systemuser,20 Apr 2026 11:19:18:147,,,10,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260410 11:11:31.393,,20260420 11:19:18.147,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20632994,Closed,systemuser,06 May 2026 06:20:15:500,systemuser,06 May 2026 06:20:19:740,systemuser,06 May 2026 06:20:19:747,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 06:20:15.500,20260506 06:20:19.740,20260506 06:20:19.747,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,20050987,Closed,SanchariDutta@025,20 Apr 2026 06:37:50:523,BrezVe1,20 Apr 2026 11:28:45:643,SanchariDutta@025,06 May 2026 12:50:15:523,,0,16,"ECG: Please verify if the ECG was collected at Visit 3 Part 1 Baseline and sent to vendor, else clarify.",ecg sent,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260420 06:37:50.523,20260420 11:28:45.643,20260506 12:50:15.523,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,20742599,Closed,SanchariDutta@025,11 May 2026 07:54:04:230,BrezVe1,11 May 2026 08:52:31:163,SanchariDutta@025,12 May 2026 06:12:15:143,,0,1,RQ-ECG1: In vendor file ECG collected for Visit 3 Part 1 Baseline (DOUBLE-BLIND DAY 1) is recorded with the date 25-Mar-2026. Kindly check and confirm the correct collection date and time along with provide the transmittal number in query response. ,"ECG under unscheduled, transmittal number is 153775953, DCF will be done in ERT Clario",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260511 07:54:04.230,20260511 08:52:31.163,20260512 06:12:15.143,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Visit 8 Part 1 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,20915933,Closed,shyamaprasad972,19 May 2026 12:47:10:123,EHerman2,20 May 2026 12:02:23:567,shyamaprasad972,21 May 2026 07:47:02:070,,1,1,Medical Review I-12758914: Kindly provide the clinical significance of high triglyceride as there is reported hypercholesterolemia in MH page. Kindly clarify if there is any worsening of existing MH.,not clinically significant,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260519 12:47:10.123,20260520 12:02:23.567,20260521 07:47:02.070,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040006,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your sleep problems?",Auto,19937298,Closed,systemuser,13 Apr 2026 10:47:26:567,systemuser,20 Apr 2026 07:36:03:707,systemuser,20 Apr 2026 07:36:03:710,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260413 10:47:26.567,20260420 07:36:03.707,20260420 07:36:03.710,98,335,335,16,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933431,Closed,systemuser,20 May 2026 12:12:32:870,,,systemuser,20 May 2026 12:16:26:923,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:12:32.870,,20260520 12:16:26.923,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,20607114,Closed,systemuser,05 May 2026 07:18:17:060,,,systemuser,06 May 2026 07:33:47:347,,,1,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 07:18:17.060,,20260506 07:33:47.347,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,19433992,Closed,kavya@1510,10 Mar 2026 04:02:05:080,gnovotna@email.cz2,19 Mar 2026 13:14:29:967,kavya@1510,20 Mar 2026 05:38:11:860,,9,1,Eligibility: Kindly update the AE page with appropriate details.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 04:02:05.080,20260319 13:14:29.967,20260320 05:38:11.860,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,19470782,Closed,kavya@1510,11 Mar 2026 15:08:54:607,gnovotna@email.cz2,19 Mar 2026 13:17:00:517,kavya@1510,20 Mar 2026 05:35:52:383,,8,1,Eligibility: Kindly confirm if there is any plan for revision surgery and if participant is on any medication for this condition.,There is no plan for revision surgery and the participant is not taking any medications for this condition.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260311 15:08:54.607,20260319 13:17:00.517,20260320 05:35:52.383,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,DM,20424991,Closed,Juhita@ksha4,27 Apr 2026 06:33:14:383,BrezVe1,27 Apr 2026 08:33:59:727,Juhita@ksha4,27 Apr 2026 13:05:15:177,,0,0,Medical Review I-7088767: Kindly mention the indication for surgical procedure in a separate log line.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 06:33:14.383,20260427 08:33:59.727,20260427 13:05:15.177,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,19470677,Closed,kavya@1510,11 Mar 2026 14:57:32:933,gnovotna@email.cz2,19 Mar 2026 13:25:18:790,kavya@1510,20 Mar 2026 05:35:36:937,,8,1,"Eligibility: Kindly clarify the underlying cause for the recorded MH, also confirm clinical stability and functional impact during study period.","These are occasional, mild back pains that require the use of analgesics once every 1 to 2 months. They are most likely caused by age-related arthritic changes. These pains do not have a significant impact on the patient's functioning.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260311 14:57:32.933,20260319 13:25:18.790,20260320 05:35:36.937,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,"MGH ATRQ, Geriatric, Section I and II",0/0/N,1,Generic Name,Auto,19240762,Closed,systemuser,02 Mar 2026 18:06:59:180,systemuser,02 Mar 2026 18:09:30:137,systemuser,02 Mar 2026 18:09:30:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 18:06:59.180,20260302 18:09:30.137,20260302 18:09:30.137,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,20115487,Closed,systemuser,22 Apr 2026 12:55:47:927,systemuser,22 Apr 2026 12:55:57:450,systemuser,22 Apr 2026 12:55:57:453,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:55:47.927,20260422 12:55:57.450,20260422 12:55:57.453,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19882661,Closed,Ashwini201,09 Apr 2026 07:12:20:510,BrezVe1,20 Apr 2026 11:21:04:493,Ashwini201,21 Apr 2026 15:12:26:987,,11,1,"DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 07:12:20.510,20260420 11:21:04.493,20260421 15:12:26.987,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,19688496,Closed,systemuser,25 Mar 2026 07:41:23:090,,,systemuser,30 Mar 2026 09:19:41:233,,,5,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:41:23.090,,20260330 09:19:41.233,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,20607113,Closed,systemuser,05 May 2026 07:18:16:987,,,systemuser,06 May 2026 07:32:37:037,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 07:18:16.987,,20260506 07:32:37.037,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,20744202,Closed,SanchariDutta@025,11 May 2026 08:53:37:857,BrezVe1,11 May 2026 10:10:50:913,SanchariDutta@025,12 May 2026 06:13:33:247,,0,1,"ECG: Please verify if the ECG was collected at Visit 3 Part 1 Baseline and sent to vendor. If collected, kindly provide the transmittal number in query response.",transmittal number is 154868756. DCF will be added to ERT Clario,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260511 08:53:37.857,20260511 10:10:50.913,20260512 06:13:33.247,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,1. Reported Sadness,Auto,19688384,Closed,systemuser,25 Mar 2026 07:38:29:087,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.087,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,2. Apparent Sadness,Auto,19688385,Closed,systemuser,25 Mar 2026 07:38:29:093,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.093,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,3. Inner Tension,Auto,19688386,Closed,systemuser,25 Mar 2026 07:38:29:103,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.103,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,4. Reduced Sleep,Auto,19688387,Closed,systemuser,25 Mar 2026 07:38:29:110,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.110,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,5. Reduced Appetite,Auto,19688388,Closed,systemuser,25 Mar 2026 07:38:29:113,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.113,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,6. Concentration Difficulties,Auto,19688389,Closed,systemuser,25 Mar 2026 07:38:29:120,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.120,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,7. Lassitude,Auto,19688390,Closed,systemuser,25 Mar 2026 07:38:29:127,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.127,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,8. Inability to Feel,Auto,19688391,Closed,systemuser,25 Mar 2026 07:38:29:133,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.133,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,9. Pessimistic Thoughts,Auto,19688392,Closed,systemuser,25 Mar 2026 07:38:29:140,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.140,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,19688393,Closed,systemuser,25 Mar 2026 07:38:29:147,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.147,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,19688394,Closed,systemuser,25 Mar 2026 07:38:29:153,systemuser,25 Mar 2026 07:39:42:633,systemuser,25 Mar 2026 07:39:42:633,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.153,20260325 07:39:42.633,20260325 07:39:42.633,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Rater's Initials,Auto,19688383,Closed,systemuser,25 Mar 2026 07:38:29:080,systemuser,25 Mar 2026 07:39:42:397,systemuser,25 Mar 2026 07:39:42:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.080,20260325 07:39:42.397,20260325 07:39:42.397,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 3 Part 1 Baseline,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Was the collection date the same as the visit date?,Auto,19688382,Closed,systemuser,25 Mar 2026 07:38:29:073,systemuser,25 Mar 2026 07:39:42:380,systemuser,25 Mar 2026 07:39:42:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 07:38:29.073,20260325 07:39:42.380,20260325 07:39:42.380,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Ideation1. Wish to be Dead,Auto,19868675,Closed,systemuser,08 Apr 2026 12:08:33:327,systemuser,08 Apr 2026 12:09:09:760,systemuser,08 Apr 2026 12:09:09:760,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.327,20260408 12:09:09.760,20260408 12:09:09.760,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,2. Non-Specific Active Suicidal Thoughts,Auto,19868676,Closed,systemuser,08 Apr 2026 12:08:33:337,systemuser,08 Apr 2026 12:09:09:760,systemuser,08 Apr 2026 12:09:09:760,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.337,20260408 12:09:09.760,20260408 12:09:09.760,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal BehaviorActual Attempt,Auto,19868677,Closed,systemuser,08 Apr 2026 12:08:33:373,systemuser,08 Apr 2026 12:09:09:777,systemuser,08 Apr 2026 12:09:09:777,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.373,20260408 12:09:09.777,20260408 12:09:09.777,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,19868678,Closed,systemuser,08 Apr 2026 12:08:33:383,systemuser,08 Apr 2026 12:09:09:777,systemuser,08 Apr 2026 12:09:09:777,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.383,20260408 12:09:09.777,20260408 12:09:09.777,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Interrupted Attempt,Auto,19868679,Closed,systemuser,08 Apr 2026 12:08:33:390,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.390,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Aborted Attempt,Auto,19868680,Closed,systemuser,08 Apr 2026 12:08:33:400,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.400,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Preparatory Acts or Behavior,Auto,19868681,Closed,systemuser,08 Apr 2026 12:08:33:410,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.410,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Behavior,Auto,19868682,Closed,systemuser,08 Apr 2026 12:08:33:420,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.420,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicide,Auto,19868683,Closed,systemuser,08 Apr 2026 12:08:33:427,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.427,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Rater's Initials,Auto,19868674,Closed,systemuser,08 Apr 2026 12:08:33:320,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.320,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Was the collection date the same as the visit date?,Auto,19868673,Closed,systemuser,08 Apr 2026 12:08:33:310,systemuser,08 Apr 2026 12:09:09:780,systemuser,08 Apr 2026 12:09:09:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:08:33.310,20260408 12:09:09.780,20260408 12:09:09.780,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040007,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19936534,Closed,systemuser,13 Apr 2026 10:08:41:383,systemuser,13 Apr 2026 10:08:56:837,systemuser,13 Apr 2026 10:08:56:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260413 10:08:41.383,20260413 10:08:56.837,20260413 10:08:56.840,98,335,335,13,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,End Date,Auto,20424960,Closed,systemuser,27 Apr 2026 06:32:21:070,systemuser,27 Apr 2026 06:33:01:427,systemuser,27 Apr 2026 06:33:01:450,,0,0,"If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 06:32:21.070,20260427 06:33:01.427,20260427 06:33:01.450,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Outcome,DM,20744052,Closed,Ashwini201,11 May 2026 08:46:50:330,BrezVe1,11 May 2026 09:00:58:680,Ashwini201,11 May 2026 12:39:44:350,,0,0,"DM: End date is updated as 08Apr2026 however outcome reported as Not Recovered or Not Resolved. Please verify and update the data as appropriate, else clarify. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260511 08:46:50.330,20260511 09:00:58.680,20260511 12:39:44.350,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,What is the adverse event term?,DM,20882876,Closed,Juhita@ksha4,18 May 2026 07:13:12:357,EHerman2,19 May 2026 08:45:55:507,Juhita@ksha4,19 May 2026 09:21:23:130,,1,0,"Medical Review I-12758848: Kindly clarify time of the day when AE occurs, if it is continuous or intermittent and if it affect daily routine activity.","cuntinuous, daily routine activity mildly affected",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260518 07:13:12.357,20260519 08:45:55.507,20260519 09:21:23.130,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,Frequency,Site from Medical Reviewer,19527250,Closed,Rajani_S_N1,16 Mar 2026 10:48:52:137,EHerman2,19 Mar 2026 07:16:54:707,Rajani_S_N1,19 Mar 2026 11:24:58:147,,3,0,Eligibility: Kindly mention the frequency at which subject needs to take NIMESULIDE,approximately 2 times in month,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:48:52.137,20260319 07:16:54.707,20260319 11:24:58.147,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,19424767,Closed,systemuser,09 Mar 2026 13:19:10:440,systemuser,09 Mar 2026 13:20:23:663,systemuser,09 Mar 2026 13:20:23:667,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260309 13:19:10.440,20260309 13:20:23.663,20260309 13:20:23.667,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,Start Date,Auto,19424784,Closed,systemuser,09 Mar 2026 13:20:23:787,systemuser,09 Mar 2026 13:20:51:017,systemuser,09 Mar 2026 13:20:51:037,,0,0,"Response to 'Was the medication/therapy taken prior to the study' is No, however, 'Start Date' is prior to the 'Informed Consent Date' (""<core:link text='datapoint.uservalue' formoid='DM_GL_900' folderoid='SCREEN' fieldoid='RFICDAT' />"") on the ""<core:link text='Demographics' formoid='DM_GL_900' folderoid='SCREEN' />"" form. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260309 13:20:23.787,20260309 13:20:51.017,20260309 13:20:51.037,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",DM,20566175,Closed,shyamaprasad972,30 Apr 2026 11:50:39:370,BrezVe1,04 May 2026 09:28:45:500,Ashwini201,04 May 2026 11:08:02:073,,4,0,DM: Please verify and update the correct spelling of the indication.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 11:50:39.370,20260504 09:28:45.500,20260504 11:08:02.073,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,20589161,Closed,systemuser,04 May 2026 09:28:17:163,BrezVe1,04 May 2026 09:28:39:377,Ashwini201,04 May 2026 11:07:19:253,,0,0,The selected logline has been modified from  '#001 > CARVICOBRACHIAL SYNDROME' to '#001 > CERVICOBRACHIAL SYNDROME' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260504 09:28:17.163,20260504 09:28:39.377,20260504 11:07:19.253,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933457,Closed,systemuser,20 May 2026 12:13:25:987,,,systemuser,20 May 2026 12:13:41:363,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:13:25.987,,20260520 12:13:41.363,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,20639879,Closed,systemuser,06 May 2026 07:45:41:780,,,systemuser,06 May 2026 08:44:50:400,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 07:45:41.780,,20260506 08:44:50.400,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Screening Visit 1,Alcohol Test,0/0/N,,Alcohol Test Result,Auto,19423582,Closed,systemuser,09 Mar 2026 12:54:59:050,systemuser,09 Mar 2026 12:55:14:493,systemuser,09 Mar 2026 12:55:14:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260309 12:54:59.050,20260309 12:55:14.493,20260309 12:55:14.497,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Screening Visit 1,Alcohol Test,0/0/N,,Collection Date,Auto,19423581,Closed,systemuser,09 Mar 2026 12:54:59:040,systemuser,09 Mar 2026 12:55:14:497,systemuser,09 Mar 2026 12:55:14:497,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260309 12:54:59.040,20260309 12:55:14.497,20260309 12:55:14.497,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,19527423,Closed,Rajani_S_N1,16 Mar 2026 10:53:06:733,EHerman2,19 Mar 2026 07:18:22:820,Rajani_S_N1,19 Mar 2026 11:29:24:007,,3,0,Eligibility: Kindly mention the severity and clinical stability of medical condition -  Cervicobrachial syndrome,"chronic relatively stabile condition, mild severity, approximately one times in month requires analgetic. ",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:53:06.733,20260319 07:18:22.820,20260319 11:29:24.007,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19882667,Closed,Ashwini201,09 Apr 2026 07:13:28:930,BrezVe1,20 Apr 2026 11:21:12:690,Ashwini201,21 Apr 2026 15:12:11:383,,11,1,"DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 07:13:28.930,20260420 11:21:12.690,20260421 15:12:11.383,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,19693540,Closed,systemuser,25 Mar 2026 10:47:30:980,,,systemuser,30 Mar 2026 09:20:17:303,,,5,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:47:30.980,,20260330 09:20:17.303,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,20639878,Closed,systemuser,06 May 2026 07:45:41:737,,,systemuser,06 May 2026 07:54:01:297,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 07:45:41.737,,20260506 07:54:01.297,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,19693474,Closed,systemuser,25 Mar 2026 10:45:23:383,systemuser,25 Mar 2026 10:46:21:547,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.383,20260325 10:46:21.547,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,19693475,Closed,systemuser,25 Mar 2026 10:45:23:393,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.393,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,19693476,Closed,systemuser,25 Mar 2026 10:45:23:400,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.400,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,19693477,Closed,systemuser,25 Mar 2026 10:45:23:410,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.410,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,19693478,Closed,systemuser,25 Mar 2026 10:45:23:417,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.417,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,19693479,Closed,systemuser,25 Mar 2026 10:45:23:423,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.423,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,19693480,Closed,systemuser,25 Mar 2026 10:45:23:430,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.430,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,19693473,Closed,systemuser,25 Mar 2026 10:45:23:370,systemuser,25 Mar 2026 10:46:21:550,systemuser,25 Mar 2026 10:46:21:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:45:23.370,20260325 10:46:21.550,20260325 10:46:21.550,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,19693435,Closed,systemuser,25 Mar 2026 10:43:14:070,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.070,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,19693436,Closed,systemuser,25 Mar 2026 10:43:14:080,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.080,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,19693437,Closed,systemuser,25 Mar 2026 10:43:14:087,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.087,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,19693438,Closed,systemuser,25 Mar 2026 10:43:14:090,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.090,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,19693439,Closed,systemuser,25 Mar 2026 10:43:14:097,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.097,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,19693440,Closed,systemuser,25 Mar 2026 10:43:14:103,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.103,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,19693441,Closed,systemuser,25 Mar 2026 10:43:14:113,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.113,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,19693442,Closed,systemuser,25 Mar 2026 10:43:14:117,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.117,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,19693434,Closed,systemuser,25 Mar 2026 10:43:14:060,systemuser,25 Mar 2026 10:44:56:527,systemuser,25 Mar 2026 10:44:56:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:43:14.060,20260325 10:44:56.527,20260325 10:44:56.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Body Mass Index,Auto,19790121,Closed,systemuser,01 Apr 2026 07:49:42:180,systemuser,01 Apr 2026 07:50:11:860,systemuser,01 Apr 2026 07:50:11:863,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.180,20260401 07:50:11.860,20260401 07:50:11.863,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,19790125,Closed,systemuser,01 Apr 2026 07:49:42:317,systemuser,01 Apr 2026 07:50:11:877,systemuser,01 Apr 2026 07:50:11:877,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.317,20260401 07:50:11.877,20260401 07:50:11.877,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Pulse,Auto,19790123,Closed,systemuser,01 Apr 2026 07:49:42:253,systemuser,01 Apr 2026 07:50:11:887,systemuser,01 Apr 2026 07:50:11:887,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.253,20260401 07:50:11.887,20260401 07:50:11.887,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,19790124,Closed,systemuser,01 Apr 2026 07:49:42:283,systemuser,01 Apr 2026 07:50:11:893,systemuser,01 Apr 2026 07:50:11:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.283,20260401 07:50:11.893,20260401 07:50:11.893,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,19790119,Closed,systemuser,01 Apr 2026 07:49:42:117,systemuser,01 Apr 2026 07:50:11:893,systemuser,01 Apr 2026 07:50:11:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.117,20260401 07:50:11.893,20260401 07:50:11.893,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature,Auto,19790122,Closed,systemuser,01 Apr 2026 07:49:42:213,systemuser,01 Apr 2026 07:50:11:893,systemuser,01 Apr 2026 07:50:11:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.213,20260401 07:50:11.893,20260401 07:50:11.893,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Weight,Auto,19790120,Closed,systemuser,01 Apr 2026 07:49:42:157,systemuser,01 Apr 2026 07:50:11:893,systemuser,01 Apr 2026 07:50:11:893,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 07:49:42.157,20260401 07:50:11.893,20260401 07:50:11.893,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,19865696,Closed,systemuser,08 Apr 2026 10:13:48:173,systemuser,08 Apr 2026 10:14:19:817,systemuser,08 Apr 2026 10:14:19:820,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.173,20260408 10:14:19.817,20260408 10:14:19.820,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,19865697,Closed,systemuser,08 Apr 2026 10:13:48:183,systemuser,08 Apr 2026 10:14:19:820,systemuser,08 Apr 2026 10:14:19:820,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.183,20260408 10:14:19.820,20260408 10:14:19.820,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,19865698,Closed,systemuser,08 Apr 2026 10:13:48:220,systemuser,08 Apr 2026 10:14:19:840,systemuser,08 Apr 2026 10:14:19:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.220,20260408 10:14:19.840,20260408 10:14:19.840,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,19865699,Closed,systemuser,08 Apr 2026 10:13:48:257,systemuser,08 Apr 2026 10:14:19:840,systemuser,08 Apr 2026 10:14:19:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.257,20260408 10:14:19.840,20260408 10:14:19.840,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,19865700,Closed,systemuser,08 Apr 2026 10:13:48:267,systemuser,08 Apr 2026 10:14:19:840,systemuser,08 Apr 2026 10:14:19:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.267,20260408 10:14:19.840,20260408 10:14:19.840,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,19865701,Closed,systemuser,08 Apr 2026 10:13:48:277,systemuser,08 Apr 2026 10:14:19:840,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.277,20260408 10:14:19.840,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,19865702,Closed,systemuser,08 Apr 2026 10:13:48:297,systemuser,08 Apr 2026 10:14:19:843,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.297,20260408 10:14:19.843,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,19865703,Closed,systemuser,08 Apr 2026 10:13:48:313,systemuser,08 Apr 2026 10:14:19:843,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.313,20260408 10:14:19.843,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,19865704,Closed,systemuser,08 Apr 2026 10:13:48:327,systemuser,08 Apr 2026 10:14:19:843,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.327,20260408 10:14:19.843,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,19865695,Closed,systemuser,08 Apr 2026 10:13:48:167,systemuser,08 Apr 2026 10:14:19:843,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.167,20260408 10:14:19.843,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,19865694,Closed,systemuser,08 Apr 2026 10:13:48:150,systemuser,08 Apr 2026 10:14:19:843,systemuser,08 Apr 2026 10:14:19:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 10:13:48.150,20260408 10:14:19.843,20260408 10:14:19.843,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,20428553,Closed,systemuser,27 Apr 2026 08:26:06:767,systemuser,27 Apr 2026 08:26:27:517,systemuser,27 Apr 2026 08:26:27:523,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.767,20260427 08:26:27.517,20260427 08:26:27.523,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,20428554,Closed,systemuser,27 Apr 2026 08:26:06:777,systemuser,27 Apr 2026 08:26:27:527,systemuser,27 Apr 2026 08:26:27:527,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.777,20260427 08:26:27.527,20260427 08:26:27.527,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,20428555,Closed,systemuser,27 Apr 2026 08:26:06:807,systemuser,27 Apr 2026 08:26:27:553,systemuser,27 Apr 2026 08:26:27:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.807,20260427 08:26:27.553,20260427 08:26:27.553,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,20428556,Closed,systemuser,27 Apr 2026 08:26:06:817,systemuser,27 Apr 2026 08:26:27:553,systemuser,27 Apr 2026 08:26:27:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.817,20260427 08:26:27.553,20260427 08:26:27.553,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,20428557,Closed,systemuser,27 Apr 2026 08:26:06:827,systemuser,27 Apr 2026 08:26:27:553,systemuser,27 Apr 2026 08:26:27:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.827,20260427 08:26:27.553,20260427 08:26:27.553,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,20428558,Closed,systemuser,27 Apr 2026 08:26:06:837,systemuser,27 Apr 2026 08:26:27:553,systemuser,27 Apr 2026 08:26:27:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.837,20260427 08:26:27.553,20260427 08:26:27.553,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,20428559,Closed,systemuser,27 Apr 2026 08:26:06:850,systemuser,27 Apr 2026 08:26:27:557,systemuser,27 Apr 2026 08:26:27:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.850,20260427 08:26:27.557,20260427 08:26:27.557,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,20428560,Closed,systemuser,27 Apr 2026 08:26:06:860,systemuser,27 Apr 2026 08:26:27:557,systemuser,27 Apr 2026 08:26:27:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.860,20260427 08:26:27.557,20260427 08:26:27.557,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,20428561,Closed,systemuser,27 Apr 2026 08:26:06:870,systemuser,27 Apr 2026 08:26:27:557,systemuser,27 Apr 2026 08:26:27:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.870,20260427 08:26:27.557,20260427 08:26:27.557,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,20428552,Closed,systemuser,27 Apr 2026 08:26:06:760,systemuser,27 Apr 2026 08:26:27:557,systemuser,27 Apr 2026 08:26:27:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.760,20260427 08:26:27.557,20260427 08:26:27.557,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040008,Enrolled,Visit 7 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,20428551,Closed,systemuser,27 Apr 2026 08:26:06:733,systemuser,27 Apr 2026 08:26:27:557,systemuser,27 Apr 2026 08:26:27:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 08:26:06.733,20260427 08:26:27.557,20260427 08:26:27.557,98,335,335,15,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Frequency,Site from Medical Reviewer,20021675,Closed,Mamatha.K1,17 Apr 2026 06:14:12:037,BrezVe1,20 Apr 2026 11:22:20:627,Mamatha.K1,21 Apr 2026 03:43:26:213,,3,1,Eligibility : Kindly clarify if the &quot;as necessary&quot; usage has been stable for at least 12 weeks and is expected to remain stable during the course of the trial,stable,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260417 06:14:12.037,20260420 11:22:20.627,20260421 03:43:26.213,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933474,Closed,systemuser,20 May 2026 12:14:11:487,,,systemuser,20 May 2026 12:14:27:593,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:14:11.487,,20260520 12:14:27.593,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,20841000,Closed,Ashwini201,14 May 2026 10:14:00:767,BrezVe1,18 May 2026 08:25:28:157,Ashwini201,18 May 2026 09:32:29:530,,4,0,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260514 10:14:00.767,20260518 08:25:28.157,20260518 09:32:29.530,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,20021790,Closed,Mamatha.K1,17 Apr 2026 06:16:21:937,BrezVe1,20 Apr 2026 11:54:40:870,Mamatha.K1,21 Apr 2026 03:45:24:690,,3,1,Eligibility: Please clarify if the subject is permanently sterilized or postmenopausal. Update as applicable,data are correct,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260417 06:16:21.937,20260420 11:54:40.870,20260421 03:45:24.690,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,20069479 (20021790),Closed,Mamatha.K1,21 Apr 2026 03:45:24:867,BrezVe1,22 Apr 2026 12:50:23:640,Mamatha.K1,23 Apr 2026 05:10:12:783,,1,1,Eligibility Re- Query : Thank you for the confirmation. Please provide when was the last menses or since when is the subject Menopausal,will be reviewed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 03:45:24.867,20260422 12:50:23.640,20260423 05:10:12.783,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,20128411 (20069479),Closed,Mamatha.K1,23 Apr 2026 05:10:12:987,gnovotna@email.cz2,23 Apr 2026 14:15:54:603,Mamatha.K1,24 Apr 2026 04:33:50:053,,0,1,"Eligibility Re-Query: Kindly note, this information is needed for determining the subject eligibility because per protocol &quot;A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.&quot;.Please provide the details once available",pateint is permanently sterilized from 2005,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 05:10:12.987,20260423 14:15:54.603,20260424 04:33:50.053,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,20163350 (20128411),Closed,Mamatha.K1,24 Apr 2026 04:33:50:500,gnovotna@email.cz2,28 Apr 2026 13:15:48:793,Mamatha.K1,29 Apr 2026 04:06:52:567,,4,1,Eligibility : thank you for the confirmation. Please select the appropriate child beraring potential as per your response,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260424 04:33:50.500,20260428 13:15:48.793,20260429 04:06:52.567,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,DM,20078473,Closed,CoderImport,21 Apr 2026 10:39:43:553,BrezVe1,22 Apr 2026 12:47:59:660,systemuser,22 Apr 2026 12:48:00:813,,1,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.OSTEOTOMY FOR GRADE 3 OSTEOARTHRITIS OF THE KNEE OF THE RIGHT LOWER LIMB and 2. OSTEOTOMY. Thank you.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 10:39:43.553,20260422 12:47:59.660,20260422 12:48:00.813,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,20021686,Closed,Mamatha.K1,17 Apr 2026 06:14:59:720,BrezVe1,20 Apr 2026 11:55:00:603,Mamatha.K1,21 Apr 2026 03:45:52:650,,3,1,Eligibility: Please clarify if this was total hysterectomy or partial,partial,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260417 06:14:59.720,20260420 11:55:00.603,20260421 03:45:52.650,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,DM,20078470,Closed,CoderImport,21 Apr 2026 10:38:45:050,BrezVe1,22 Apr 2026 12:46:44:277,systemuser,22 Apr 2026 12:46:44:983,,1,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.  MYOMA and 2. HYSTERECTOMY AND OVARIECTOMY. Thank you.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 10:38:45.050,20260422 12:46:44.277,20260422 12:46:44.983,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,20625662,Closed,systemuser,05 May 2026 14:29:39:990,systemuser,05 May 2026 14:31:19:430,systemuser,05 May 2026 14:31:19:433,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 14:29:39.990,20260505 14:31:19.430,20260505 14:31:19.433,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,20625655,Closed,systemuser,05 May 2026 14:29:04:153,,,systemuser,06 May 2026 07:35:33:563,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 14:29:04.153,,20260506 07:35:33.563,98,335,335,8,186,713,713
CZE,S10-CZ10004,Medical Services Prague s.r.o.,CZ100040009,Enrolled,Visit 1.1 Induction Baseline (1),Date of Visit,0/0/N,,Visit Start Date,Auto,20633606,Closed,systemuser,06 May 2026 07:08:12:080,BrezVe1,06 May 2026 07:09:14:597,systemuser,06 May 2026 09:39:50:360,,0,0,Date of visit should be greater than the last date of visit. Please reconcile.,data are correct,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 07:08:12.080,20260506 07:09:14.597,20260506 09:39:50.360,98,335,335,8,186,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,7,"If Yes, Medication or Therapy",Site from Medical Reviewer,16041202,Closed,inayath1,19 Sep 2025 05:42:17:200,spinkova@email.cz2,03 Oct 2025 07:54:03:017,meghal.choksi@iqvia.com1,03 Oct 2025 10:19:26:423,,14,0,Eligibility: Please justify updating Duloxetine in 2 loglines without change in dosage. ,there is a change in dosage,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 05:42:17.200,20251003 07:54:03.017,20251003 10:19:26.423,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251003 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,16252402,Closed,systemuser,03 Oct 2025 07:51:36:110,systemuser,03 Oct 2025 07:55:06:530,systemuser,03 Oct 2025 07:55:06:650,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251003 07:51:36.110,20251003 07:55:06.530,20251003 07:55:06.650,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal Ideation1. Wish to be DeadLifetime,Auto,15875831,Closed,systemuser,09 Sep 2025 10:17:25:517,systemuser,09 Sep 2025 10:19:36:537,systemuser,09 Sep 2025 10:19:36:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.517,20250909 10:19:36.537,20250909 10:19:36.540,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 6 Months,Auto,15875832,Closed,systemuser,09 Sep 2025 10:17:25:530,systemuser,09 Sep 2025 10:19:36:553,systemuser,09 Sep 2025 10:19:36:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.530,20250909 10:19:36.553,20250909 10:19:36.553,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,2. Non-Specific Active Suicidal ThoughtsLifetime,Auto,15875833,Closed,systemuser,09 Sep 2025 10:17:25:543,systemuser,09 Sep 2025 10:19:36:553,systemuser,09 Sep 2025 10:19:36:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.543,20250909 10:19:36.553,20250909 10:19:36.553,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 6 Months,Auto,15875834,Closed,systemuser,09 Sep 2025 10:17:25:553,systemuser,09 Sep 2025 10:19:36:553,systemuser,09 Sep 2025 10:19:36:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.553,20250909 10:19:36.553,20250909 10:19:36.553,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal BehaviorActual AttemptLifetime,Auto,15875835,Closed,systemuser,09 Sep 2025 10:17:25:730,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.730,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875836,Closed,systemuser,09 Sep 2025 10:17:25:743,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.743,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?Lifetime,Auto,15875837,Closed,systemuser,09 Sep 2025 10:17:25:777,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.777,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875838,Closed,systemuser,09 Sep 2025 10:17:25:787,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.787,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Interrupted AttemptLifetime,Auto,15875839,Closed,systemuser,09 Sep 2025 10:17:25:797,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.797,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875840,Closed,systemuser,09 Sep 2025 10:17:25:807,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.807,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Aborted AttemptLifetime,Auto,15875841,Closed,systemuser,09 Sep 2025 10:17:25:837,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.837,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875842,Closed,systemuser,09 Sep 2025 10:17:25:853,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.853,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Preparatory Acts or BehaviorLifetime,Auto,15875843,Closed,systemuser,09 Sep 2025 10:17:25:880,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.880,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875844,Closed,systemuser,09 Sep 2025 10:17:25:890,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.890,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Suicidal BehaviorLifetime,Auto,15875845,Closed,systemuser,09 Sep 2025 10:17:25:907,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.907,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,15875846,Closed,systemuser,09 Sep 2025 10:17:25:917,systemuser,09 Sep 2025 10:19:36:557,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.917,20250909 10:19:36.557,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Rater's Initials,Auto,15875830,Closed,systemuser,09 Sep 2025 10:17:25:507,systemuser,09 Sep 2025 10:19:36:553,systemuser,09 Sep 2025 10:19:36:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.507,20250909 10:19:36.553,20250909 10:19:36.557,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Was the collection date the same as the visit date?,Auto,15875829,Closed,systemuser,09 Sep 2025 10:17:25:480,systemuser,09 Sep 2025 10:19:36:553,systemuser,09 Sep 2025 10:19:36:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 10:17:25.480,20250909 10:19:36.553,20250909 10:19:36.553,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,16252400,Closed,systemuser,03 Oct 2025 07:50:57:867,spinkova@email.cz2,03 Oct 2025 07:54:47:593,shyamaprasad972,06 Oct 2025 06:17:53:703,,0,3,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",I confirm,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251003 07:50:57.867,20251003 07:54:47.593,20251006 06:17:53.703,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,DM,15953427,Closed,CoderImport,14 Sep 2025 06:07:02:803,spinkova@email.cz2,03 Oct 2025 07:46:34:010,systemuser,03 Oct 2025 07:46:34:190,,19,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.  MYOMA and 2. HYSTERECTOMY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250914 06:07:02.803,20251003 07:46:34.010,20251003 07:46:34.190,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16041221,Closed,inayath1,19 Sep 2025 05:47:10:473,spinkova@email.cz2,03 Oct 2025 07:46:39:603,meghal.choksi@iqvia.com1,03 Oct 2025 10:19:26:497,,14,0,Eligibility: Please confirm whether hysterectomy was partial or complete. ,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 05:47:10.473,20251003 07:46:39.603,20251003 10:19:26.497,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,General Medical History,0/0/N,7,What is the verbatim term for the medical history condition/event?,DM,16340823,Closed,CoderImport,09 Oct 2025 14:12:18:973,spinkova@email.cz2,19 Nov 2025 16:16:49:787,systemuser,19 Nov 2025 16:16:49:940,,41,0,CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. UTERINE MYOMA and 2. HYSTERECTOMY.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 14:12:18.973,20251119 16:16:49.787,20251119 16:16:49.940,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,General Medical History,0/0/N,7,Start Date,Auto,17104107,Closed,systemuser,19 Nov 2025 16:15:24:390,,,systemuser,19 Nov 2025 16:15:35:890,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 16:15:24.390,,20251119 16:15:35.890,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050001,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15886841,Closed,systemuser,09 Sep 2025 18:01:13:100,systemuser,09 Sep 2025 18:01:29:863,systemuser,09 Sep 2025 18:01:29:863,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 18:01:13.100,20250909 18:01:29.863,20250909 18:01:29.863,6,335,335,6,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Indication,Site from Medical Reviewer,16932878,Closed,joetrombello1,11 Nov 2025 20:20:46:790,spinkova@email.cz2,19 Nov 2025 16:19:43:590,MAhmad203,19 Nov 2025 19:13:29:000,,8,0,medical reviewer: Pls clarify if the primary indication was major depression or related conditions like insomnia or anxiety. Please review and revise here and in MH if deemed clinically necessary.,insomnia in depressive disorder,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 20:20:46.790,20251119 16:19:43.590,20251119 19:13:29.000,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Indication,Site from Medical Reviewer,17108322 (16932878),Closed,MAhmad203,19 Nov 2025 19:13:29:220,spinkova@email.cz2,02 Feb 2026 14:26:30:617,ewajs1,12 Feb 2026 13:59:09:793,,75,10,"Since Trazodone was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 19:13:29.220,20260202 14:26:30.617,20260212 13:59:09.793,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Indication,Site from Medical Reviewer,18037493,Closed,MAhmad203,17 Dec 2025 03:25:01:397,spinkova@email.cz2,02 Feb 2026 14:26:42:047,ewajs1,12 Feb 2026 13:59:15:613,,47,10,"Since Trazodone was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page.  Insomnia is a comorbidity of MDD.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251217 03:25:01.397,20260202 14:26:42.047,20260212 13:59:15.613,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Indication,Auto,18723688,Closed,systemuser,02 Feb 2026 14:26:22:163,spinkova@email.cz2,02 Feb 2026 14:26:35:477,Ashwini201,05 Feb 2026 09:53:06:330,,0,3,"""Is this a medication/therapy taken for current episode of depression?"" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 14:26:22.163,20260202 14:26:35.477,20260205 09:53:06.330,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,16773754,Closed,systemuser,04 Nov 2025 13:15:44:733,systemuser,04 Nov 2025 13:18:27:157,systemuser,04 Nov 2025 13:18:27:160,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251104 13:15:44.733,20251104 13:18:27.157,20251104 13:18:27.160,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,18723689,Closed,systemuser,02 Feb 2026 14:26:22:177,systemuser,02 Feb 2026 14:29:31:210,systemuser,02 Feb 2026 14:29:31:210,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 14:26:22.177,20260202 14:29:31.210,20260202 14:29:31.210,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,Indication,Site from Medical Reviewer,16932856,Closed,joetrombello1,11 Nov 2025 20:20:24:310,spinkova@email.cz2,19 Nov 2025 16:20:04:587,MAhmad203,19 Nov 2025 19:15:31:997,,8,0,medical reviewer: Pls clarify if the primary indication was major depression or related conditions like insomnia or anxiety. Please review and revise here and in MH if deemed clinically necessary.,insomnia in depressive disorder,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 20:20:24.310,20251119 16:20:04.587,20251119 19:15:31.997,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,Indication,Site from Medical Reviewer,17108379 (16932856),Closed,MAhmad203,19 Nov 2025 19:15:32:157,spinkova@email.cz2,02 Feb 2026 14:30:23:670,ewajs1,12 Feb 2026 14:00:46:317,,75,10,"Since quetiapine was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 19:15:32.157,20260202 14:30:23.670,20260212 14:00:46.317,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,Indication,Site from Medical Reviewer,18037500,Closed,MAhmad203,17 Dec 2025 03:25:47:727,spinkova@email.cz2,02 Feb 2026 14:30:38:450,ewajs1,12 Feb 2026 14:00:49:960,,47,10,"Since quetiapine was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page  Insomnia is a comorbidity of MDD",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251217 03:25:47.727,20260202 14:30:38.450,20260212 14:00:49.960,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,Indication,Auto,18723777,Closed,systemuser,02 Feb 2026 14:29:56:473,spinkova@email.cz2,02 Feb 2026 14:30:31:563,Ashwini201,05 Feb 2026 09:53:16:663,,0,3,"""Is this a medication/therapy taken for current episode of depression?"" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 14:29:56.473,20260202 14:30:31.563,20260205 09:53:16.663,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,End Date,Site from Medical Reviewer,17004570,Cancelled,kavya@1510,14 Nov 2025 09:07:50:083,,,kavya@1510,20 Nov 2025 20:21:36:950,,,,"Eligibility: Please note, ongoing Antipsychotics are prohibited at least 14 days prior to Day 1 until the Follow-up visit. Kindly comment if the subject agrees to discontinue drug &amp; PI consider Clinically indicated to discontinue. If so, Can PI confirm whether drug can be safely tapered off with washout of 14 days as per exclusion #29 &amp; prohibited medication section 6.9.2.",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 09:07:50.083,,20251120 20:21:36.950,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260211 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,17104258,Closed,systemuser,19 Nov 2025 16:23:30:060,systemuser,11 Feb 2026 12:26:55:840,systemuser,11 Feb 2026 12:26:55:997,,84,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 16:23:30.060,20260211 12:26:55.840,20260211 12:26:55.997,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,17104254,Closed,systemuser,19 Nov 2025 16:22:36:277,spinkova@email.cz2,19 Nov 2025 16:25:32:903,Ashwini201,21 Nov 2025 09:08:28:397,,0,2,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",I confirm,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 16:22:36.277,20251119 16:25:32.903,20251121 09:08:28.397,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16996619,Closed,kavya@1510,13 Nov 2025 20:10:53:490,spinkova@email.cz2,19 Nov 2025 16:18:15:230,kavya@1510,20 Nov 2025 20:21:03:403,,6,1,Eligibility: Kindly update details in the AE page with Yes or No.,the page is complete,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 20:10:53.490,20251119 16:18:15.230,20251120 20:21:03.403,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18173132,Closed,Ashwini201,23 Dec 2025 07:08:45:840,spinkova@email.cz2,02 Feb 2026 14:31:28:140,shyamaprasad972,03 Feb 2026 08:38:05:610,,41,1,DM: Please verify and update the field 'Were any adverse events experienced?' on Adverse event form.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:08:45.840,20260202 14:31:28.140,20260203 08:38:05.610,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Screening Visit 1,Demographics,0/0/N,,Sex reported at birth,Auto,16765790,Closed,systemuser,04 Nov 2025 09:43:51:270,systemuser,04 Nov 2025 09:44:15:627,systemuser,04 Nov 2025 09:44:15:640,,0,0,"Sex reported at birth is 'Male. However, What is the subject's childbearing potential? is selected other than 'Not Applicable'. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251104 09:43:51.270,20251104 09:44:15.627,20251104 09:44:15.640,6,335,335,5,11,713,713
CZE,S10-CZ10005,A-Shine s.r.o.,CZ100050002,Screen Failed,Screening Visit 1,Psychiatric History for Major Depressive Disorder,0/0/N,1,Psychiatric Disorder,Auto,16770588,Closed,systemuser,04 Nov 2025 11:48:48:333,systemuser,04 Nov 2025 11:49:22:097,systemuser,04 Nov 2025 11:49:22:100,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251104 11:48:48.333,20251104 11:49:22.097,20251104 11:49:22.100,6,335,335,5,11,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,2,Is the medication/therapy still ongoing?,DM,19723934,Closed,JThoma858,26 Mar 2026 11:48:28:717,v.smidkova1,09 Apr 2026 06:31:57:270,JThoma858,13 Apr 2026 07:22:23:443,,14,4,"DM: Please note the drug is given for current episode of depression and recorded in MGH ATRQ-Non Geriatric Section I and II , however the drug is not ongoing in CM form. As per guidance &quot; End Date should be blank (if there are multiple records, then previous record may have end date/dose change, but current record should match MGH-ATRQ&quot;'. Kindly recheck and verify. Else clarify",The subject used dose 300 mg of Venlafaxine from 22Feb2023 (150 mg twice daily) and then the dose 75 mg was added on 18Sep2024. The total dose from 18 Sep2024 was 375 mg (this dose is mentioned in MGH-ATRQ),42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 11:48:28.717,20260409 06:31:57.270,20260413 07:22:23.443,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,2,Start Date,DM,18628769,Closed,Lisa232,27 Jan 2026 08:11:58:273,v.smidkova1,29 Jan 2026 07:31:11:753,Lisa232,12 Feb 2026 11:01:21:600,,2,14,DM: The start date 18 Sep 2024 of the logline#2 is overlapping with the end date 30 Jan 2025 of logline #1. Please verify and update the dates accordingly. ,"The patient was taking 150 mg from 22.2.2023, on 18.9.2024 the dose was increased from 75 mg to 225 mg daily.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260127 08:11:58.273,20260129 07:31:11.753,20260212 11:01:21.600,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,2,Start Date,DM,18906071,Cancelled,Lisa232,12 Feb 2026 11:03:13:677,,,Lisa232,12 Feb 2026 11:04:45:677,,,,"RQ-DM1: Response noted, however the start date of logline 6 cannot be the same as the end date of logline 3. Please verify and update the dates accordingly.",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 11:03:13.677,,20260212 11:04:45.677,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,2,Start Date,DM,18906145,Closed,Lisa232,12 Feb 2026 11:05:02:080,v.smidkova1,17 Feb 2026 07:38:36:860,Lisa232,23 Feb 2026 07:58:54:970,,5,6,"RQ-DM1: As per query response, CM dose was increased on 18 Sep 2024, however, start date of logline 2 is overlapping with logline 1. Please review and amend or clarify.","ADT does not overlap, as 150mg was increased by 75mg for a total daily intake of 225mg. 150mg was taken twice daily 75mg was taken once daily",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 11:05:02.080,20260217 07:38:36.860,20260223 07:58:54.970,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,"If Prophylaxis or Other, Specify",Auto,14468174,Closed,systemuser,17 Jul 2025 09:43:16:880,systemuser,17 Jul 2025 09:47:02:313,systemuser,17 Jul 2025 09:47:02:313,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250717 09:43:16.880,20250717 09:47:02.313,20250717 09:47:02.313,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Follow-up 7-14 Days After (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,17207779,Closed,systemuser,24 Nov 2025 07:14:28:817,systemuser,24 Nov 2025 07:14:35:507,systemuser,24 Nov 2025 07:14:35:510,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251124 07:14:28.817,20251124 07:14:35.507,20251124 07:14:35.510,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251211 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,17891908,Closed,systemuser,10 Dec 2025 11:17:04:190,systemuser,11 Dec 2025 07:42:01:720,systemuser,11 Dec 2025 07:42:01:833,,1,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 11:17:04.190,20251211 07:42:01.720,20251211 07:42:01.833,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933069,Closed,systemuser,20 May 2026 11:56:48:300,,,systemuser,20 May 2026 11:57:37:753,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 11:56:48.300,,20260520 11:57:37.753,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Drug Expiry Information,0/0/N,,Did the subject take all investigational medication within the expiry timeframe?,Auto,18571810,Closed,systemuser,22 Jan 2026 06:46:38:950,systemuser,22 Jan 2026 06:46:52:907,systemuser,22 Jan 2026 06:46:52:907,,0,0,There are no active logline in this form. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 06:46:38.950,20260122 06:46:52.907,20260122 06:46:52.907,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,1,Start date of menstrual period,DM,15765188,Closed,Ashwini201,02 Sep 2025 15:44:45:360,v.smidkova1,11 Sep 2025 11:14:35:773,Ashwini201,14 Oct 2025 13:35:32:047,,9,33,"DM: Please verify and update the menstrual cycle data for month of Jul and Aug 2025, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 15:44:45.360,20250911 11:14:35.773,20251014 13:35:32.047,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,2,Stop date of menstrual period,DM,16398884,Closed,Ashwini201,14 Oct 2025 13:37:27:723,m.deif2,16 Oct 2025 07:55:08:213,Ashwini201,16 Oct 2025 08:34:20:310,,2,0,"DM: Please verify and update the end date as appropriate, else clarify. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251014 13:37:27.723,20251016 07:55:08.213,20251016 08:34:20.310,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,3,Stop date of menstrual period,DM,19445871,Cancelled,JThoma858,10 Mar 2026 13:43:33:933,,,JThoma858,10 Mar 2026 13:43:43:343,,,,DM: Please update the Menstrual Cycle Tracking Log for the month of Sep and Oct c 2025. else clarify.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 13:43:33.933,,20260310 13:43:43.343,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,3,Stop date of menstrual period,DM,19445879,Closed,JThoma858,10 Mar 2026 13:44:03:500,v.smidkova1,12 Mar 2026 07:42:30:470,JThoma858,16 Mar 2026 05:43:02:297,,2,4,DM: Please update the Menstrual Cycle Tracking Log for the month of Sep and Oct 2025. else clarify,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 13:44:03.500,20260312 07:42:30.470,20260316 05:43:02.297,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,5,Stop date of menstrual period,DM,20567074,Closed,JThoma858,30 Apr 2026 12:45:34:723,v.smidkova1,06 May 2026 09:02:07:683,JThoma858,07 May 2026 08:28:31:273,,6,1,DM: Kindly update the menstrual cycle data for the month of Nov 2025.,the last menstrual cycle record is  9.10-14.10.2025,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 12:45:34.723,20260506 09:02:07.683,20260507 08:28:31.273,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,15895070,Closed,systemuser,10 Sep 2025 08:51:06:850,,,systemuser,11 Sep 2025 11:18:02:913,,,1,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:06.850,,20250911 11:18:02.913,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Treatment Disposition - Induction,0/0/V,,Treatment Disposition Date,DM,19612747,Closed,Juhita@ksha4,20 Mar 2026 07:38:16:723,v.smidkova1,25 Mar 2026 12:15:18:540,Juhita@ksha4,25 Mar 2026 15:05:41:027,,5,0,Medical Review I-3085490: Please revise the date to align with the date of in-clinic visit where the decision to discontinue treatment occurred.,done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260320 07:38:16.723,20260325 12:15:18.540,20260325 15:05:41.027,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,Auto,17891929,Closed,systemuser,10 Dec 2025 11:18:12:573,systemuser,11 Dec 2025 07:27:53:967,systemuser,11 Dec 2025 07:27:53:967,,1,0,"The 'Disposition Date' is not equal to or after the 'Treatment Disposition Date' ""<core:link text='datapoint.uservalue' formoid='DS_GL_908' folderoid='SCRDS' fieldoid='DSSTDAT_TDD' />"" on the ""<core:link text='Treatment Disposition' formoid='DS_GL_908' folderoid='SCRDS' />"" form. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 11:18:12.573,20251211 07:27:53.967,20251211 07:27:53.967,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,18460679,Closed,Ashwini201,15 Jan 2026 13:04:54:990,v.smidkova1,22 Jan 2026 06:48:07:680,shyamaprasad972,22 Jan 2026 14:46:51:627,,7,0,"DM: Please verify and update the data on all blank forms of Screening to end of study, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 13:04:54.990,20260122 06:48:07.680,20260122 14:46:51.627,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Arizona Sexual Experiences Scale Summary,0/0/N,,Which version of the Arizona Sexual Experiences Scale will be used?,DM,15661544,Closed,shyamaprasad972,28 Aug 2025 08:45:42:283,v.smidkova1,08 Sep 2025 11:30:37:463,shyamaprasad972,10 Sep 2025 13:52:22:177,,11,2,"DM: This form is asking which ASEX will be used for this subject, not if it was completed during this visit. Please update to generate form for V3 assessment.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 08:45:42.283,20250908 11:30:37.463,20250910 13:52:22.177,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Site from Medical Reviewer,14344059,Closed,inayath1,15 Jul 2025 13:17:12:307,v.smidkova1,16 Jul 2025 12:15:29:003,inayath1,16 Jul 2025 13:08:23:063,,1,0,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250715 13:17:12.307,20250716 12:15:29.003,20250716 13:08:23.063,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,14344053,Closed,inayath1,15 Jul 2025 13:16:36:503,v.smidkova1,16 Jul 2025 12:14:45:160,inayath1,16 Jul 2025 13:08:43:073,,1,0,Eligibility: Please fill Drug Testing and alcohol testing forms. ,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250715 13:16:36.503,20250716 12:14:45.160,20250716 13:08:43.073,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,15552688,Closed,Ashwini201,25 Aug 2025 10:00:38:473,v.smidkova1,25 Aug 2025 11:54:55:840,Ashwini201,26 Aug 2025 07:47:00:980,,0,1,"DM: Please verify and update the data on Educational Level form, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250825 10:00:38.473,20250825 11:54:55.840,20250826 07:47:00.980,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,15582050,Closed,Ashwini201,26 Aug 2025 07:53:39:833,v.smidkova1,28 Aug 2025 06:10:09:490,shyamaprasad972,28 Aug 2025 08:45:19:577,,2,0,"DM: Please reactivate the Arizona Sexual Experiences Scale Summary form and update the data as appropriate, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 07:53:39.833,20250828 06:10:09.490,20250828 08:45:19.577,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18460722,Closed,Ashwini201,15 Jan 2026 13:06:53:950,v.smidkova1,22 Jan 2026 06:45:23:157,shyamaprasad972,22 Jan 2026 14:47:56:300,,7,0,DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.,Procedures were added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 13:06:53.950,20260122 06:45:23.157,20260122 14:47:56.300,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,14343775,Closed,inayath1,15 Jul 2025 13:08:54:143,v.smidkova1,17 Jul 2025 08:06:12:990,meghal.choksi@iqvia.com1,18 Sep 2025 11:12:11:967,,2,63,Eligibility: As per updates the subject is of childbearing potential. Please update the contraceptive method being used by the subject.,ADDED,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250715 13:08:54.143,20250717 08:06:12.990,20250918 11:12:11.967,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Demographics,0/0/V,,What was the date of the signature on informed consent?,Auto,13950832,Closed,systemuser,07 Jul 2025 08:45:48:930,systemuser,08 Jul 2025 09:26:05:607,systemuser,08 Jul 2025 09:26:05:607,,1,0,Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250707 08:45:48.930,20250708 09:26:05.607,20250708 09:26:05.607,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Demographics,0/0/V,,Sex reported at birth,Site from Medical Reviewer,14344103,Closed,inayath1,15 Jul 2025 13:18:27:210,v.smidkova1,16 Jul 2025 12:15:45:830,inayath1,16 Jul 2025 13:11:22:427,,1,0,Eligibility: Please fill Menstrual Cycle Tracking form as per completion guidelines.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250715 13:18:27.210,20250716 12:15:45.830,20250716 13:11:22.427,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Demographics,0/0/V,,What is the protocol date the subject consented to at study start?,Auto,13950833,Closed,systemuser,07 Jul 2025 08:45:48:990,systemuser,08 Jul 2025 09:26:05:610,systemuser,08 Jul 2025 09:26:05:610,,1,0,The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250707 08:45:48.990,20250708 09:26:05.610,20250708 09:26:05.610,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Start Date,Auto,14446782,Closed,systemuser,16 Jul 2025 12:06:35:770,systemuser,17 Jul 2025 08:05:29:590,systemuser,17 Jul 2025 08:05:29:593,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250716 12:06:35.770,20250717 08:05:29.590,20250717 08:05:29.593,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Is it ongoing?,Auto,14446783,Closed,systemuser,16 Jul 2025 12:06:35:787,systemuser,17 Jul 2025 08:05:29:593,systemuser,17 Jul 2025 08:05:29:593,,1,0,Please enter the response for 'End Date' or 'Is it ongoing'.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250716 12:06:35.787,20250717 08:05:29.593,20250717 08:05:29.593,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,15089446,Closed,systemuser,01 Aug 2025 08:49:42:567,systemuser,01 Aug 2025 08:51:11:300,systemuser,01 Aug 2025 08:51:11:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250801 08:49:42.567,20250801 08:51:11.300,20250801 08:51:11.307,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Pregnancy Test,0/0/N,,Pregnancy Test Result,Auto,13950840,Closed,systemuser,07 Jul 2025 08:46:54:727,systemuser,10 Jul 2025 10:51:20:600,systemuser,10 Jul 2025 10:51:20:603,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250707 08:46:54.727,20250710 10:51:20.600,20250710 10:51:20.603,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,13964535,Closed,systemuser,07 Jul 2025 13:19:49:323,systemuser,08 Jul 2025 09:24:07:583,systemuser,08 Jul 2025 09:24:07:583,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250707 13:19:49.323,20250708 09:24:07.583,20250708 09:24:07.583,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,15605971,Closed,systemuser,27 Aug 2025 10:08:18:913,systemuser,27 Aug 2025 10:08:37:743,systemuser,27 Aug 2025 10:08:37:743,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250827 10:08:18.913,20250827 10:08:37.743,20250827 10:08:37.743,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Subject's Status,Auto,15016522,Closed,systemuser,29 Jul 2025 05:43:27:960,systemuser,29 Jul 2025 05:43:42:423,systemuser,29 Jul 2025 05:43:42:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250729 05:43:27.960,20250729 05:43:42.423,20250729 05:43:42.423,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15020947,Closed,systemuser,29 Jul 2025 09:12:54:567,,,systemuser,29 Jul 2025 09:13:03:663,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250729 09:12:54.567,,20250729 09:13:03.663,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15020952,Closed,systemuser,29 Jul 2025 09:13:06:183,,,systemuser,29 Jul 2025 09:20:17:777,,,0,Date of visit should be greater than the last date of visit. Please reconcile.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250729 09:13:06.183,,20250729 09:20:17.777,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,Site from Medical Reviewer,16801433,Closed,ewajs1,05 Nov 2025 11:25:40:117,v.smidkova1,12 Nov 2025 12:56:21:550,ewajs1,26 Nov 2025 09:18:08:570,,7,14,"Please verify the end date and correct all the end dates on this page. The participant had last visit (V.8) in the Double Blind Part 1 on 10 Sep25, the last dose would be 09 Sep25 Sep25",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 11:25:40.117,20251112 12:56:21.550,20251126 09:18:08.570,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,15895069,Closed,systemuser,10 Sep 2025 08:51:06:807,,,systemuser,11 Sep 2025 11:15:04:767,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:06.807,,20250911 11:15:04.767,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,5,End Date,Auto,16956037,Closed,systemuser,12 Nov 2025 12:59:56:273,systemuser,12 Nov 2025 13:01:40:553,systemuser,12 Nov 2025 13:01:40:557,,0,0,The End Date must be equal to or after the Start Date. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 12:59:56.273,20251112 13:01:40.553,20251112 13:01:40.557,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.5 Induction (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,16317799,Closed,systemuser,08 Oct 2025 10:37:10:350,systemuser,09 Oct 2025 09:24:35:773,systemuser,09 Oct 2025 09:24:35:783,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251008 10:37:10.350,20251009 09:24:35.773,20251009 09:24:35.783,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,16546632,Closed,systemuser,23 Oct 2025 12:25:39:667,systemuser,23 Oct 2025 12:26:15:250,systemuser,23 Oct 2025 12:26:15:250,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.667,20251023 12:26:15.250,20251023 12:26:15.250,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,16546633,Closed,systemuser,23 Oct 2025 12:25:39:683,systemuser,23 Oct 2025 12:26:15:250,systemuser,23 Oct 2025 12:26:15:250,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.683,20251023 12:26:15.250,20251023 12:26:15.250,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,16546634,Closed,systemuser,23 Oct 2025 12:25:39:820,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.820,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,16546635,Closed,systemuser,23 Oct 2025 12:25:39:850,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.850,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,16546636,Closed,systemuser,23 Oct 2025 12:25:39:863,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.863,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,16546637,Closed,systemuser,23 Oct 2025 12:25:39:890,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.890,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,16546638,Closed,systemuser,23 Oct 2025 12:25:39:910,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.910,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,16546639,Closed,systemuser,23 Oct 2025 12:25:39:927,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.927,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,16546640,Closed,systemuser,23 Oct 2025 12:25:39:940,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.940,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,16546631,Closed,systemuser,23 Oct 2025 12:25:39:653,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.653,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,16546630,Closed,systemuser,23 Oct 2025 12:25:39:620,systemuser,23 Oct 2025 12:26:15:253,systemuser,23 Oct 2025 12:26:15:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 12:25:39.620,20251023 12:26:15.253,20251023 12:26:15.253,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.6 Induction (1),Pregnancy Test,0/0/N,,Was the sample collected?,Auto,16521323,Closed,systemuser,22 Oct 2025 09:44:51:233,systemuser,24 Oct 2025 08:55:10:383,systemuser,24 Oct 2025 08:55:10:387,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 09:44:51.233,20251024 08:55:10.383,20251024 08:55:10.387,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 1.7 Induction (1),Date of Visit,0/0/N,,Did this visit occur?,DM,17287140,Closed,Ashwini201,25 Nov 2025 14:03:08:863,m.deif2,27 Nov 2025 09:49:10:267,Ashwini201,28 Nov 2025 09:45:13:800,,2,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:03:08.863,20251127 09:49:10.267,20251128 09:45:13.800,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,15042224,Closed,systemuser,30 Jul 2025 09:45:43:227,systemuser,30 Jul 2025 09:46:24:133,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.227,20250730 09:46:24.133,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,15042225,Closed,systemuser,30 Jul 2025 09:45:43:287,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.287,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,15042226,Closed,systemuser,30 Jul 2025 09:45:43:347,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.347,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,15042227,Closed,systemuser,30 Jul 2025 09:45:43:410,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.410,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,15042228,Closed,systemuser,30 Jul 2025 09:45:43:463,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.463,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,15042229,Closed,systemuser,30 Jul 2025 09:45:43:510,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.510,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,15042230,Closed,systemuser,30 Jul 2025 09:45:43:553,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.553,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,15042223,Closed,systemuser,30 Jul 2025 09:45:43:083,systemuser,30 Jul 2025 09:46:24:137,systemuser,30 Jul 2025 09:46:24:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:45:43.083,20250730 09:46:24.137,20250730 09:46:24.137,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,15042324,Closed,systemuser,30 Jul 2025 09:46:57:670,systemuser,30 Jul 2025 09:47:34:373,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.670,20250730 09:47:34.373,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,15042325,Closed,systemuser,30 Jul 2025 09:46:57:680,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.680,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,15042326,Closed,systemuser,30 Jul 2025 09:46:57:690,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.690,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,15042327,Closed,systemuser,30 Jul 2025 09:46:57:700,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.700,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,15042328,Closed,systemuser,30 Jul 2025 09:46:57:713,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.713,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,15042329,Closed,systemuser,30 Jul 2025 09:46:57:723,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.723,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,15042330,Closed,systemuser,30 Jul 2025 09:46:57:733,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.733,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,15042331,Closed,systemuser,30 Jul 2025 09:46:57:740,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.740,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,15042332,Closed,systemuser,30 Jul 2025 09:46:57:750,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.750,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,15042333,Closed,systemuser,30 Jul 2025 09:46:57:760,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.760,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,15042323,Closed,systemuser,30 Jul 2025 09:46:57:647,systemuser,30 Jul 2025 09:47:34:377,systemuser,30 Jul 2025 09:47:34:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:46:57.647,20250730 09:47:34.377,20250730 09:47:34.377,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,15042350,Closed,systemuser,30 Jul 2025 09:48:02:153,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.153,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,15042351,Closed,systemuser,30 Jul 2025 09:48:02:187,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.187,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,15042352,Closed,systemuser,30 Jul 2025 09:48:02:220,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.220,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,15042353,Closed,systemuser,30 Jul 2025 09:48:02:253,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.253,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,15042354,Closed,systemuser,30 Jul 2025 09:48:02:280,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.280,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,15042355,Closed,systemuser,30 Jul 2025 09:48:02:290,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.290,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,15042356,Closed,systemuser,30 Jul 2025 09:48:02:300,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.300,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,15042357,Closed,systemuser,30 Jul 2025 09:48:02:310,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.310,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,15042349,Closed,systemuser,30 Jul 2025 09:48:02:077,systemuser,30 Jul 2025 09:49:12:077,systemuser,30 Jul 2025 09:49:12:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250730 09:48:02.077,20250730 09:49:12.077,20250730 09:49:12.077,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,15200459,Closed,systemuser,07 Aug 2025 06:54:54:753,systemuser,07 Aug 2025 06:55:41:353,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.753,20250807 06:55:41.353,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,15200460,Closed,systemuser,07 Aug 2025 06:54:54:770,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.770,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,15200461,Closed,systemuser,07 Aug 2025 06:54:54:873,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.873,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,15200462,Closed,systemuser,07 Aug 2025 06:54:54:897,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.897,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,15200463,Closed,systemuser,07 Aug 2025 06:54:54:903,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.903,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,15200464,Closed,systemuser,07 Aug 2025 06:54:54:927,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.927,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,15200465,Closed,systemuser,07 Aug 2025 06:54:54:950,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.950,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,15200466,Closed,systemuser,07 Aug 2025 06:54:54:967,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.967,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,15200467,Closed,systemuser,07 Aug 2025 06:54:54:973,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.973,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,15200458,Closed,systemuser,07 Aug 2025 06:54:54:740,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.740,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,15200457,Closed,systemuser,07 Aug 2025 06:54:54:717,systemuser,07 Aug 2025 06:55:41:357,systemuser,07 Aug 2025 06:55:41:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 06:54:54.717,20250807 06:55:41.357,20250807 06:55:41.357,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,15321769,Closed,systemuser,13 Aug 2025 10:20:43:457,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.457,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,15321770,Closed,systemuser,13 Aug 2025 10:20:43:473,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.473,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,15321771,Closed,systemuser,13 Aug 2025 10:20:43:480,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.480,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,15321772,Closed,systemuser,13 Aug 2025 10:20:43:483,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.483,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,15321773,Closed,systemuser,13 Aug 2025 10:20:43:493,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.493,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,15321774,Closed,systemuser,13 Aug 2025 10:20:43:500,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.500,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,15321775,Closed,systemuser,13 Aug 2025 10:20:43:510,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.510,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,15321776,Closed,systemuser,13 Aug 2025 10:20:43:517,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.517,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,15321777,Closed,systemuser,13 Aug 2025 10:20:43:523,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.523,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,15321778,Closed,systemuser,13 Aug 2025 10:20:43:530,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.530,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,15321768,Closed,systemuser,13 Aug 2025 10:20:43:437,systemuser,13 Aug 2025 10:21:29:823,systemuser,13 Aug 2025 10:21:29:823,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:20:43.437,20250813 10:21:29.823,20250813 10:21:29.823,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,15321790,Closed,systemuser,13 Aug 2025 10:21:37:883,systemuser,13 Aug 2025 10:22:22:803,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.883,20250813 10:22:22.803,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,15321791,Closed,systemuser,13 Aug 2025 10:21:37:893,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.893,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,15321792,Closed,systemuser,13 Aug 2025 10:21:37:900,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.900,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,15321793,Closed,systemuser,13 Aug 2025 10:21:37:910,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.910,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,15321794,Closed,systemuser,13 Aug 2025 10:21:37:917,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.917,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,15321795,Closed,systemuser,13 Aug 2025 10:21:37:927,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.927,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,15321796,Closed,systemuser,13 Aug 2025 10:21:37:933,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.933,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,15321797,Closed,systemuser,13 Aug 2025 10:21:37:940,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.940,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 6 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,15321789,Closed,systemuser,13 Aug 2025 10:21:37:863,systemuser,13 Aug 2025 10:22:22:807,systemuser,13 Aug 2025 10:22:22:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250813 10:21:37.863,20250813 10:22:22.807,20250813 10:22:22.807,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Alcohol Test,0/0/N,,Alcohol Test Result,Auto,15634465,Closed,systemuser,28 Aug 2025 06:14:35:180,systemuser,28 Aug 2025 06:14:45:303,systemuser,28 Aug 2025 06:14:45:303,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:14:35.180,20250828 06:14:45.303,20250828 06:14:45.303,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Alcohol Test,0/0/N,,Collection Date,Auto,15634464,Closed,systemuser,28 Aug 2025 06:14:35:163,systemuser,28 Aug 2025 06:14:45:307,systemuser,28 Aug 2025 06:14:45:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:14:35.163,20250828 06:14:45.307,20250828 06:14:45.307,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,15634004,Closed,systemuser,28 Aug 2025 06:12:42:143,systemuser,28 Aug 2025 06:14:27:483,systemuser,28 Aug 2025 06:14:27:487,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.143,20250828 06:14:27.483,20250828 06:14:27.487,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,15634005,Closed,systemuser,28 Aug 2025 06:12:42:360,systemuser,28 Aug 2025 06:14:27:487,systemuser,28 Aug 2025 06:14:27:487,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.360,20250828 06:14:27.487,20250828 06:14:27.487,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,15634006,Closed,systemuser,28 Aug 2025 06:12:42:373,systemuser,28 Aug 2025 06:14:27:487,systemuser,28 Aug 2025 06:14:27:487,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.373,20250828 06:14:27.487,20250828 06:14:27.487,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,15634007,Closed,systemuser,28 Aug 2025 06:12:42:380,systemuser,28 Aug 2025 06:14:27:487,systemuser,28 Aug 2025 06:14:27:487,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.380,20250828 06:14:27.487,20250828 06:14:27.487,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,15634008,Closed,systemuser,28 Aug 2025 06:12:42:390,systemuser,28 Aug 2025 06:14:27:487,systemuser,28 Aug 2025 06:14:27:487,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.390,20250828 06:14:27.487,20250828 06:14:27.487,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,15634003,Closed,systemuser,28 Aug 2025 06:12:42:133,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.133,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,15634009,Closed,systemuser,28 Aug 2025 06:12:42:400,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.400,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,15634011,Closed,systemuser,28 Aug 2025 06:12:42:417,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.417,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,15634010,Closed,systemuser,28 Aug 2025 06:12:42:410,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.410,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,15634012,Closed,systemuser,28 Aug 2025 06:12:42:423,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.423,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,15634002,Closed,systemuser,28 Aug 2025 06:12:42:120,systemuser,28 Aug 2025 06:14:27:507,systemuser,28 Aug 2025 06:14:27:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:42.120,20250828 06:14:27.507,20250828 06:14:27.507,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Pregnancy Test,0/0/N,,Pregnancy Test Result,Auto,15633996,Closed,systemuser,28 Aug 2025 06:12:12:907,systemuser,28 Aug 2025 06:12:21:920,systemuser,28 Aug 2025 06:12:21:923,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:12.907,20250828 06:12:21.920,20250828 06:12:21.923,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Pregnancy Test,0/0/N,,Specimen Type,Auto,15633995,Closed,systemuser,28 Aug 2025 06:12:12:887,systemuser,28 Aug 2025 06:12:21:923,systemuser,28 Aug 2025 06:12:21:923,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:12.887,20250828 06:12:21.923,20250828 06:12:21.923,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Pregnancy Test,0/0/N,,Was the collection date the same as the visit date?,Auto,15633994,Closed,systemuser,28 Aug 2025 06:12:12:870,systemuser,28 Aug 2025 06:12:21:923,systemuser,28 Aug 2025 06:12:21:923,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:12:12.870,20250828 06:12:21.923,20250828 06:12:21.923,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,15635839,Closed,systemuser,28 Aug 2025 06:23:17:730,systemuser,28 Aug 2025 06:24:03:363,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.730,20250828 06:24:03.363,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,15635840,Closed,systemuser,28 Aug 2025 06:23:17:740,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.740,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,15635841,Closed,systemuser,28 Aug 2025 06:23:17:750,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.750,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,15635842,Closed,systemuser,28 Aug 2025 06:23:17:760,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.760,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,15635843,Closed,systemuser,28 Aug 2025 06:23:17:770,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.770,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,15635844,Closed,systemuser,28 Aug 2025 06:23:17:780,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.780,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,15635845,Closed,systemuser,28 Aug 2025 06:23:17:790,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.790,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,15635846,Closed,systemuser,28 Aug 2025 06:23:17:800,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.800,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,15635838,Closed,systemuser,28 Aug 2025 06:23:17:710,systemuser,28 Aug 2025 06:24:03:367,systemuser,28 Aug 2025 06:24:03:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:23:17.710,20250828 06:24:03.367,20250828 06:24:03.367,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15633990,Closed,systemuser,28 Aug 2025 06:11:10:163,systemuser,28 Aug 2025 06:12:04:750,systemuser,28 Aug 2025 06:12:04:750,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 06:11:10.163,20250828 06:12:04.750,20250828 06:12:04.750,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,15895076,Closed,systemuser,10 Sep 2025 08:51:25:173,systemuser,10 Sep 2025 08:52:24:370,systemuser,10 Sep 2025 08:52:24:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.173,20250910 08:52:24.370,20250910 08:52:24.370,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,15895077,Closed,systemuser,10 Sep 2025 08:51:25:183,systemuser,10 Sep 2025 08:52:24:370,systemuser,10 Sep 2025 08:52:24:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.183,20250910 08:52:24.370,20250910 08:52:24.370,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,15895078,Closed,systemuser,10 Sep 2025 08:51:25:197,systemuser,10 Sep 2025 08:52:24:370,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.197,20250910 08:52:24.370,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,15895079,Closed,systemuser,10 Sep 2025 08:51:25:207,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.207,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,15895080,Closed,systemuser,10 Sep 2025 08:51:25:217,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.217,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,15895081,Closed,systemuser,10 Sep 2025 08:51:25:230,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.230,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,15895082,Closed,systemuser,10 Sep 2025 08:51:25:240,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.240,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,15895083,Closed,systemuser,10 Sep 2025 08:51:25:260,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.260,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,15895084,Closed,systemuser,10 Sep 2025 08:51:25:270,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.270,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,15895085,Closed,systemuser,10 Sep 2025 08:51:25:280,systemuser,10 Sep 2025 08:52:24:373,systemuser,10 Sep 2025 08:52:24:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.280,20250910 08:52:24.373,20250910 08:52:24.373,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,15895086,Closed,systemuser,10 Sep 2025 08:51:25:297,systemuser,10 Sep 2025 08:52:24:977,systemuser,10 Sep 2025 08:52:24:977,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.297,20250910 08:52:24.977,20250910 08:52:24.977,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Rater's Initials,Auto,15895075,Closed,systemuser,10 Sep 2025 08:51:25:163,systemuser,10 Sep 2025 08:52:24:390,systemuser,10 Sep 2025 08:52:24:390,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.163,20250910 08:52:24.390,20250910 08:52:24.390,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,15895074,Closed,systemuser,10 Sep 2025 08:51:25:140,systemuser,10 Sep 2025 08:52:24:393,systemuser,10 Sep 2025 08:52:24:393,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250910 08:51:25.140,20250910 08:52:24.393,20250910 08:52:24.393,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080001,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15978498,Closed,systemuser,16 Sep 2025 08:57:06:380,systemuser,16 Sep 2025 08:57:43:223,systemuser,16 Sep 2025 08:57:43:223,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250916 08:57:06.380,20250916 08:57:43.223,20250916 08:57:43.223,94,335,335,37,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Is this an AE of special interest as per protocol?,Auto,16569638,Closed,systemuser,24 Oct 2025 12:52:38:100,systemuser,29 Oct 2025 13:36:31:560,systemuser,29 Oct 2025 13:36:31:560,,5,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251024 12:52:38.100,20251029 13:36:31.560,20251029 13:36:31.560,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,"If Not recovered or Not resolved, has the event stabilized?",Auto,16569640,Closed,systemuser,24 Oct 2025 12:52:38:197,systemuser,29 Oct 2025 13:36:31:560,systemuser,29 Oct 2025 13:36:31:560,,5,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251024 12:52:38.197,20251029 13:36:31.560,20251029 13:36:31.560,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,"If Not recovered or Not resolved, has the event stabilized?",Auto,16661687,Closed,systemuser,29 Oct 2025 13:39:36:760,systemuser,12 Nov 2025 13:29:36:950,systemuser,12 Nov 2025 13:29:36:950,,14,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 13:39:36.760,20251112 13:29:36.950,20251112 13:29:36.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,What is the adverse event term?,DM,17675432,Closed,Juhita@ksha4,05 Dec 2025 13:31:45:973,v.smidkova1,18 Dec 2025 09:39:36:493,Juhita@ksha4,26 Dec 2025 19:13:45:157,,13,8,"Medical Review I-941082: Kindly clarify time of the day when AE occurs, for how long into the next day does the hypersomnia last, if it is continuous or intermittent and if it affect daily routine activity.","In the morning the patient is tired, cannot wake up, in the morning she dozes in a chair or lies down in bed, cannot finish her work. In the afternoon everything is fine",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:31:45.973,20251218 09:39:36.493,20251226 19:13:45.157,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,9,Frequency,DM,16355685,Closed,Juhita@ksha4,10 Oct 2025 11:00:29:267,m.deif2,16 Oct 2025 08:02:32:857,Juhita@ksha4,17 Oct 2025 06:13:11:770,,6,1,Medical Review I-210145: Kindly clarify if frequency is correct.,yes the data is according to the source documentation,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 11:00:29.267,20251016 08:02:32.857,20251017 06:13:11.770,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260115 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18417358,Closed,systemuser,13 Jan 2026 11:59:52:313,systemuser,15 Jan 2026 09:54:55:323,systemuser,15 Jan 2026 09:54:55:460,,2,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 11:59:52.313,20260115 09:54:55.323,20260115 09:54:55.460,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933171,Closed,systemuser,20 May 2026 11:59:10:917,,,systemuser,20 May 2026 11:59:37:773,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 11:59:10.917,,20260520 11:59:37.773,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16297702,Closed,systemuser,07 Oct 2025 10:01:04:393,,,systemuser,09 Oct 2025 09:27:31:133,,,2,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:01:04.393,,20251009 09:27:31.133,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16334215,Closed,systemuser,09 Oct 2025 09:27:46:647,,,systemuser,16 Oct 2025 08:06:25:113,,,7,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 09:27:46.647,,20251016 08:06:25.113,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,15538008,Closed,inayath1,23 Aug 2025 04:10:19:247,v.smidkova1,25 Aug 2025 11:55:22:133,inayath1,25 Aug 2025 14:18:53:117,,2,0,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250823 04:10:19.247,20250825 11:55:22.133,20250825 14:18:53.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,16124840,Closed,Ashwini201,24 Sep 2025 13:34:01:517,v.smidkova1,25 Sep 2025 07:31:52:723,Ashwini201,26 Sep 2025 13:15:53:960,,1,1,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",data added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 13:34:01.517,20250925 07:31:52.723,20250926 13:15:53.960,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,15240047,Closed,systemuser,08 Aug 2025 07:42:56:623,systemuser,12 Aug 2025 07:33:23:790,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.623,20250812 07:33:23.790,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,15240048,Closed,systemuser,08 Aug 2025 07:42:56:630,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.630,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,15240049,Closed,systemuser,08 Aug 2025 07:42:56:637,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.637,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,15240050,Closed,systemuser,08 Aug 2025 07:42:56:643,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.643,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,15240051,Closed,systemuser,08 Aug 2025 07:42:56:650,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.650,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,15240052,Closed,systemuser,08 Aug 2025 07:42:56:657,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.657,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,15240054,Closed,systemuser,08 Aug 2025 07:42:56:670,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.670,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,15240053,Closed,systemuser,08 Aug 2025 07:42:56:667,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.667,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,15240055,Closed,systemuser,08 Aug 2025 07:42:56:680,systemuser,12 Aug 2025 07:33:23:793,systemuser,12 Aug 2025 07:33:23:793,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:42:56.680,20250812 07:33:23.793,20250812 07:33:23.793,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,General Medical History,0/0/N,6,What is the verbatim term for the medical history condition/event?,DM,16363090,Closed,Juhita@ksha4,10 Oct 2025 19:43:39:873,v.smidkova1,21 Oct 2025 13:01:41:320,Juhita@ksha4,22 Oct 2025 09:15:59:023,,11,1,Medical Review I-210296: Kindly provide details of the histopathological type of cyst if available.,more information is not available,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 19:43:39.873,20251021 13:01:41.320,20251022 09:15:59.023,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,General Medical History,0/0/N,16,End Date,Auto,15241585,Closed,systemuser,08 Aug 2025 08:07:42:383,,,systemuser,08 Aug 2025 08:07:58:583,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 08:07:42.383,,20250808 08:07:58.583,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15239965,Closed,systemuser,08 Aug 2025 07:41:10:587,systemuser,08 Aug 2025 07:41:23:163,systemuser,08 Aug 2025 07:41:23:167,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:41:10.587,20250808 07:41:23.163,20250808 07:41:23.167,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15467968,Closed,systemuser,21 Aug 2025 11:40:00:777,v.smidkova1,21 Aug 2025 11:41:54:220,shyamaprasad972,08 Sep 2025 13:24:56:103,,0,18,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",NA,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250821 11:40:00.777,20250821 11:41:54.220,20250908 13:24:56.103,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/V,1,Start Date,Auto,18417583,Closed,systemuser,13 Jan 2026 12:09:32:500,,,systemuser,15 Jan 2026 09:51:09:167,,,2,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 12:09:32.500,,20260115 09:51:09.167,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/V,1,Start Date,DM,19657296,Closed,JThoma858,24 Mar 2026 06:46:33:183,v.smidkova1,25 Mar 2026 12:17:03:257,JThoma858,26 Mar 2026 05:35:52:613,,1,1,DM : Please note the start Date of Part 2 DB Maintenance should align with the same visit as v2.4 (Randomization Date).  Kindly recheck and update as necessary.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260324 06:46:33.183,20260325 12:17:03.257,20260326 05:35:52.613,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,Site from Medical Reviewer,16801459,Closed,ewajs1,05 Nov 2025 11:29:03:930,m.deif2,07 Nov 2025 10:59:34:337,ewajs1,26 Nov 2025 09:19:40:553,,2,19,Please complete the end date based on last dose taken in the DB Part 1 (before visit 8 on 07 Oct),data updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 11:29:03.930,20251107 10:59:34.337,20251126 09:19:40.553,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,15589249,Closed,systemuser,26 Aug 2025 11:04:17:520,,,systemuser,27 Aug 2025 13:18:20:970,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:04:17.520,,20250827 13:18:20.970,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,17788997,Closed,Juhita@ksha4,09 Dec 2025 11:52:41:233,v.smidkova1,11 Dec 2025 07:29:30:803,Juhita@ksha4,15 Dec 2025 07:02:09:603,,2,4,DM: Kindly update the end date.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 11:52:41.233,20251211 07:29:30.803,20251215 07:02:09.603,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,17980287 (17788997),Closed,Juhita@ksha4,15 Dec 2025 07:02:09:823,v.smidkova1,18 Dec 2025 09:34:43:897,Juhita@ksha4,26 Dec 2025 19:17:59:660,,3,8,"RQ-DM1: Please enter end date for Study Drug during Induction Phase. Per CCGs, as first dose of Stabilization Phase SDA is entered as 18Nov2025, End Date for Induction Study Drug should be one day prior if subject did not have any missed doses. Please review and clarify/update. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 07:02:09.823,20251218 09:34:43.897,20251226 19:17:59.660,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,16297701,Closed,systemuser,07 Oct 2025 10:01:04:367,,,systemuser,09 Oct 2025 09:25:13:510,,,2,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:01:04.367,,20251009 09:25:13.510,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,DM,19633823,Closed,JThoma858,23 Mar 2026 06:45:44:660,v.smidkova1,25 Mar 2026 12:17:20:837,JThoma858,27 Mar 2026 06:01:07:177,,2,2,Medical Review I-3085491 : There is overlap between phases for the date of January 12th. Please revise to align.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 06:45:44.660,20260325 12:17:20.837,20260327 06:01:07.177,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,End Date,DM,18791013,Closed,Ashwini201,05 Feb 2026 15:16:49:833,v.smidkova1,12 Feb 2026 07:43:09:567,Ashwini201,13 Feb 2026 14:45:41:227,,7,1,DM: Kindly update the end date.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 15:16:49.833,20260212 07:43:09.567,20260213 14:45:41.227,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,End Date,DM,18942175 (18791013),Closed,Ashwini201,13 Feb 2026 14:45:41:330,v.smidkova1,17 Feb 2026 07:39:41:987,shyamaprasad972,17 Feb 2026 10:16:20:000,,4,0,"RQ-DM1: Please enter end date for study drug Open Label Part 2 Stabilization. Per CCGs, it should be one day prior to V2.4.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260213 14:45:41.330,20260217 07:39:41.987,20260217 10:16:20.000,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,17064849,Closed,systemuser,18 Nov 2025 11:36:21:690,m.deif2,21 Nov 2025 10:55:32:287,systemuser,18 Dec 2025 09:35:28:650,,3,27,Please enter study drug administration start date as soon as it's available,data are not available yet,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 11:36:21.690,20251121 10:55:32.287,20251218 09:35:28.650,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.4 Induction (1),Date of Visit,0/0/N,,Did this visit occur?,DM,17287453,Closed,Ashwini201,25 Nov 2025 14:13:04:973,m.deif2,27 Nov 2025 09:55:41:890,Ashwini201,28 Nov 2025 09:46:17:903,,2,1,"DM: Please verify and update the data on Local Labs for Background Antidepressant Compliance form, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:13:04.973,20251127 09:55:41.890,20251128 09:46:17.903,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16569044,Closed,systemuser,24 Oct 2025 12:38:47:400,systemuser,24 Oct 2025 12:38:56:087,systemuser,24 Oct 2025 12:38:56:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251024 12:38:47.400,20251024 12:38:56.087,20251024 12:38:56.090,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16845850,Closed,systemuser,07 Nov 2025 06:13:06:280,systemuser,07 Nov 2025 06:13:31:337,systemuser,07 Nov 2025 06:13:31:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 06:13:06.280,20251107 06:13:31.337,20251107 06:13:31.340,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.6 Induction (1),Date of Visit,0/0/N,,Did this visit occur?,DM,18173356,Closed,Ashwini201,23 Dec 2025 07:13:13:037,v.smidkova1,02 Jan 2026 07:47:28:997,shyamaprasad972,05 Jan 2026 07:03:00:770,,10,3,"DM: Please verify and update the data on Local Labs for Background Antidepressant Compliance and Physician Withdrawal Checklist (PWC) forms, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:13:13.037,20260102 07:47:28.997,20260105 07:03:00.770,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.6 Induction (1),Drug Testing,0/0/N,,Collection Time,Auto,17099681,Closed,systemuser,19 Nov 2025 14:09:06:437,systemuser,21 Nov 2025 10:55:52:837,systemuser,21 Nov 2025 10:55:52:840,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 14:09:06.437,20251121 10:55:52.837,20251121 10:55:52.840,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Temperature,Auto,17099204,Closed,systemuser,19 Nov 2025 13:53:28:190,systemuser,21 Nov 2025 10:56:12:877,systemuser,21 Nov 2025 10:56:12:880,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 13:53:28.190,20251121 10:56:12.877,20251121 10:56:12.880,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17188243,Closed,systemuser,21 Nov 2025 10:56:12:923,systemuser,21 Nov 2025 10:56:22:103,systemuser,21 Nov 2025 10:56:22:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251121 10:56:12.923,20251121 10:56:22.103,20251121 10:56:22.103,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.2 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,18082310,Closed,systemuser,18 Dec 2025 08:25:31:800,systemuser,18 Dec 2025 08:25:40:490,systemuser,18 Dec 2025 08:25:40:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 08:25:31.800,20251218 08:25:40.490,20251218 08:25:40.490,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.2 Stabilization (1),Date of Visit,0/0/N,,Subject's Status,Auto,18082260,Closed,systemuser,18 Dec 2025 08:23:01:177,systemuser,18 Dec 2025 08:23:08:817,systemuser,18 Dec 2025 08:23:08:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 08:23:01.177,20251218 08:23:08.817,20251218 08:23:08.817,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18083188,Closed,systemuser,18 Dec 2025 08:42:06:230,systemuser,18 Dec 2025 08:42:17:323,systemuser,18 Dec 2025 08:42:17:327,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 08:42:06.230,20251218 08:42:17.323,20251218 08:42:17.327,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,18275278,Closed,systemuser,02 Jan 2026 08:06:25:870,systemuser,02 Jan 2026 08:06:33:453,systemuser,02 Jan 2026 08:06:33:453,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 08:06:25.870,20260102 08:06:33.453,20260102 08:06:33.453,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.3 Stabilization (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,18275276,Closed,systemuser,02 Jan 2026 08:06:05:790,systemuser,02 Jan 2026 08:06:13:670,systemuser,02 Jan 2026 08:06:13:673,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 08:06:05.790,20260102 08:06:13.670,20260102 08:06:13.673,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18275285,Closed,systemuser,02 Jan 2026 08:07:43:653,systemuser,02 Jan 2026 08:08:01:970,systemuser,02 Jan 2026 08:08:01:970,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 08:07:43.653,20260102 08:08:01.970,20260102 08:08:01.970,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.4 Stabilization,Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,18417394,Closed,systemuser,13 Jan 2026 12:01:29:050,systemuser,15 Jan 2026 09:52:40:747,systemuser,15 Jan 2026 09:52:40:750,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 12:01:29.050,20260115 09:52:40.747,20260115 09:52:40.750,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 2.4 Stabilization,Patient Global Impression of Severity - Insomnia,0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,18417407,Closed,systemuser,13 Jan 2026 12:02:06:430,systemuser,13 Jan 2026 12:02:10:783,systemuser,13 Jan 2026 12:02:10:787,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 12:02:06.430,20260113 12:02:10.783,20260113 12:02:10.787,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,1. How strong is your sex drive?,Auto,16654446,Closed,systemuser,29 Oct 2025 10:51:49:303,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.303,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,2. How easily are you sexually aroused (turned on)?,Auto,16654447,Closed,systemuser,29 Oct 2025 10:51:49:317,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.317,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,3. How easily does your vagina become moist or wet during sex?,Auto,16654448,Closed,systemuser,29 Oct 2025 10:51:49:337,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.337,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,4. How easily can you reach an orgasm?,Auto,16654449,Closed,systemuser,29 Oct 2025 10:51:49:347,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.347,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,5. Are your orgasms satisfying?,Auto,16654450,Closed,systemuser,29 Oct 2025 10:51:49:360,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.360,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Arizona Sexual Experiences Scale-Female,0/0/N,,Was the collection date the same as the visit date?,Auto,16654445,Closed,systemuser,29 Oct 2025 10:51:49:270,systemuser,29 Oct 2025 10:52:09:020,systemuser,29 Oct 2025 10:52:09:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 10:51:49.270,20251029 10:52:09.020,20251029 10:52:09.020,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,16602775,Closed,Ashwini201,27 Oct 2025 13:01:13:833,v.smidkova1,29 Oct 2025 10:52:40:513,Ashwini201,31 Oct 2025 08:46:23:377,,2,2,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 13:01:13.833,20251029 10:52:40.513,20251031 08:46:23.377,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,15589196,Closed,systemuser,26 Aug 2025 11:01:11:453,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.453,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,15589197,Closed,systemuser,26 Aug 2025 11:01:11:467,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.467,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,15589198,Closed,systemuser,26 Aug 2025 11:01:11:490,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.490,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,15589199,Closed,systemuser,26 Aug 2025 11:01:11:500,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.500,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,15589200,Closed,systemuser,26 Aug 2025 11:01:11:510,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.510,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,15589201,Closed,systemuser,26 Aug 2025 11:01:11:523,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.523,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,15589202,Closed,systemuser,26 Aug 2025 11:01:11:537,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.537,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,15589195,Closed,systemuser,26 Aug 2025 11:01:11:427,systemuser,26 Aug 2025 11:02:12:470,systemuser,26 Aug 2025 11:02:12:470,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250826 11:01:11.427,20250826 11:02:12.470,20250826 11:02:12.470,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,15695970,Closed,systemuser,28 Aug 2025 12:34:57:917,systemuser,28 Aug 2025 12:35:07:100,systemuser,28 Aug 2025 12:35:07:103,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 12:34:57.917,20250828 12:35:07.100,20250828 12:35:07.103,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Body Mass Index,Auto,15695739,Closed,systemuser,28 Aug 2025 12:26:30:497,systemuser,08 Sep 2025 12:31:23:583,systemuser,08 Sep 2025 12:31:23:587,,11,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 12:26:30.497,20250908 12:31:23.583,20250908 12:31:23.587,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.3 Maintenance,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19482860,Closed,systemuser,12 Mar 2026 10:04:53:403,systemuser,12 Mar 2026 10:05:06:817,systemuser,12 Mar 2026 10:05:06:820,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260312 10:04:53.403,20260312 10:05:06.817,20260312 10:05:06.820,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,19846141,Closed,systemuser,07 Apr 2026 10:04:24:843,systemuser,07 Apr 2026 10:06:48:847,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.843,20260407 10:06:48.847,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,19846142,Closed,systemuser,07 Apr 2026 10:04:24:853,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.853,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,19846143,Closed,systemuser,07 Apr 2026 10:04:24:860,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.860,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,19846144,Closed,systemuser,07 Apr 2026 10:04:24:870,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.870,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,19846145,Closed,systemuser,07 Apr 2026 10:04:24:877,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.877,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,19846146,Closed,systemuser,07 Apr 2026 10:04:24:883,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.883,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,19846147,Closed,systemuser,07 Apr 2026 10:04:24:890,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.890,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,19846148,Closed,systemuser,07 Apr 2026 10:04:24:897,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.897,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,19846149,Closed,systemuser,07 Apr 2026 10:04:24:903,systemuser,07 Apr 2026 10:06:48:857,systemuser,07 Apr 2026 10:06:48:857,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.903,20260407 10:06:48.857,20260407 10:06:48.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,19846150,Closed,systemuser,07 Apr 2026 10:04:24:910,systemuser,07 Apr 2026 10:06:55:190,systemuser,07 Apr 2026 10:06:55:193,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.910,20260407 10:06:55.190,20260407 10:06:55.193,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,19846151,Closed,systemuser,07 Apr 2026 10:04:24:913,systemuser,07 Apr 2026 10:06:59:720,systemuser,07 Apr 2026 10:06:59:720,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 10:04:24.913,20260407 10:06:59.720,20260407 10:06:59.720,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.4 Maintenance,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19888346,Closed,systemuser,09 Apr 2026 10:21:17:553,systemuser,09 Apr 2026 12:54:17:717,systemuser,09 Apr 2026 12:54:17:717,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 10:21:17.553,20260409 12:54:17.717,20260409 12:54:17.717,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,20658353,Closed,systemuser,07 May 2026 07:14:42:487,systemuser,07 May 2026 07:15:18:407,systemuser,07 May 2026 07:15:18:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 07:14:42.487,20260507 07:15:18.407,20260507 07:15:18.407,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Pulse,Auto,20658351,Closed,systemuser,07 May 2026 07:14:42:470,systemuser,07 May 2026 07:15:18:420,systemuser,07 May 2026 07:15:18:420,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 07:14:42.470,20260507 07:15:18.420,20260507 07:15:18.420,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,20658352,Closed,systemuser,07 May 2026 07:14:42:480,systemuser,07 May 2026 07:15:18:423,systemuser,07 May 2026 07:15:18:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 07:14:42.480,20260507 07:15:18.423,20260507 07:15:18.423,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,20658349,Closed,systemuser,07 May 2026 07:14:42:440,systemuser,07 May 2026 07:15:18:423,systemuser,07 May 2026 07:15:18:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 07:14:42.440,20260507 07:15:18.423,20260507 07:15:18.423,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 3.5 Maintenance,Vital Signs,0/0/N,,Temperature,Auto,20658350,Closed,systemuser,07 May 2026 07:14:42:463,systemuser,07 May 2026 07:15:18:423,systemuser,07 May 2026 07:15:18:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 07:14:42.463,20260507 07:15:18.423,20260507 07:15:18.423,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,16122087,Closed,systemuser,24 Sep 2025 11:27:22:973,systemuser,24 Sep 2025 11:28:11:870,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:22.973,20250924 11:28:11.870,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,16122088,Closed,systemuser,24 Sep 2025 11:27:23:037,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.037,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,16122089,Closed,systemuser,24 Sep 2025 11:27:23:090,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.090,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,16122090,Closed,systemuser,24 Sep 2025 11:27:23:160,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.160,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,16122091,Closed,systemuser,24 Sep 2025 11:27:23:207,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.207,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,16122092,Closed,systemuser,24 Sep 2025 11:27:23:260,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.260,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,16122093,Closed,systemuser,24 Sep 2025 11:27:23:310,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.310,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,16122094,Closed,systemuser,24 Sep 2025 11:27:23:347,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:23.347,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,16122086,Closed,systemuser,24 Sep 2025 11:27:22:860,systemuser,24 Sep 2025 11:28:11:873,systemuser,24 Sep 2025 11:28:11:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:27:22.860,20250924 11:28:11.873,20250924 11:28:11.873,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,16122112,Closed,systemuser,24 Sep 2025 11:29:31:317,systemuser,24 Sep 2025 11:29:40:813,systemuser,24 Sep 2025 11:29:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:29:31.317,20250924 11:29:40.813,20250924 11:29:40.817,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,16122113,Closed,systemuser,24 Sep 2025 11:29:31:333,systemuser,24 Sep 2025 11:29:41:087,systemuser,24 Sep 2025 11:29:41:087,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:29:31.333,20250924 11:29:41.087,20250924 11:29:41.087,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16121992,Closed,systemuser,24 Sep 2025 11:23:48:067,systemuser,24 Sep 2025 11:24:43:003,systemuser,24 Sep 2025 11:24:43:007,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:23:48.067,20250924 11:24:43.003,20250924 11:24:43.007,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,16121990,Closed,systemuser,24 Sep 2025 11:23:48:023,systemuser,24 Sep 2025 11:24:43:013,systemuser,24 Sep 2025 11:24:43:013,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:23:48.023,20250924 11:24:43.013,20250924 11:24:43.013,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,16121991,Closed,systemuser,24 Sep 2025 11:23:48:043,systemuser,24 Sep 2025 11:24:43:017,systemuser,24 Sep 2025 11:24:43:017,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:23:48.043,20250924 11:24:43.017,20250924 11:24:43.017,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,16121988,Closed,systemuser,24 Sep 2025 11:23:47:933,systemuser,24 Sep 2025 11:24:43:013,systemuser,24 Sep 2025 11:24:43:013,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:23:47.933,20250924 11:24:43.013,20250924 11:24:43.013,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080002,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,16121989,Closed,systemuser,24 Sep 2025 11:23:47:993,systemuser,24 Sep 2025 11:24:43:013,systemuser,24 Sep 2025 11:24:43:013,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 11:23:47.993,20250924 11:24:43.013,20250924 11:24:43.013,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15254230,Closed,systemuser,08 Aug 2025 12:54:02:390,systemuser,08 Aug 2025 12:54:31:287,systemuser,08 Aug 2025 12:54:31:287,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:54:02.390,20250808 12:54:31.287,20250808 12:54:31.287,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20250918 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,15753765,Closed,systemuser,02 Sep 2025 08:12:20:477,systemuser,18 Sep 2025 06:10:09:667,systemuser,18 Sep 2025 06:10:09:787,,16,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 08:12:20.477,20250918 06:10:09.667,20250918 06:10:09.787,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933180,Closed,systemuser,20 May 2026 12:01:06:533,,,systemuser,20 May 2026 12:01:26:257,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:01:06.533,,20260520 12:01:26.257,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,What was the subject's primary reason for screen failure?,Auto,15753766,Closed,systemuser,02 Sep 2025 08:12:20:513,r.gregar1,02 Sep 2025 08:13:58:217,shyamaprasad972,04 Sep 2025 07:38:40:087,,0,2,"Subject's primary reason for screen failure is 'Failure to Meet Eligibility Criteria', however, ‘Did the subject meet all eligibility criteria?’ is not selected as ‘No’ on the Inclusion/Exclusion Criteria form. Please resolve.",subject met eligibility criteria at the time of screening,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 08:12:20.513,20250902 08:13:58.217,20250904 07:38:40.087,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Site from Medical Reviewer,15334325,Closed,inayath1,14 Aug 2025 03:24:15:253,v.smidkova1,14 Aug 2025 11:20:43:833,inayath1,14 Aug 2025 14:09:48:903,,0,0,Eligibility: As per lab results the subject had abnormal urinalysis with presence of bacteria and elevated Ur Leukocyte Esterase. Please comment on clinical significance and compliance with exclusion criteria #19.,Assessed by the investigator as NCS.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250814 03:24:15.253,20250814 11:20:43.833,20250814 14:09:48.903,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,15921656,Closed,systemuser,11 Sep 2025 11:19:16:717,v.smidkova1,18 Sep 2025 09:22:55:210,Ashwini201,19 Sep 2025 10:10:46:870,,7,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250911 11:19:16.717,20250918 09:22:55.210,20250919 10:10:46.870,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,15334275,Closed,inayath1,14 Aug 2025 03:21:02:510,v.smidkova1,14 Aug 2025 07:19:44:637,inayath1,14 Aug 2025 14:09:44:597,,0,0,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250814 03:21:02.510,20250814 07:19:44.637,20250814 14:09:44.597,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,15254067,Closed,systemuser,08 Aug 2025 12:43:18:320,systemuser,14 Aug 2025 11:15:07:547,systemuser,14 Aug 2025 11:15:07:547,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.320,20250814 11:15:07.547,20250814 11:15:07.547,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,15254068,Closed,systemuser,08 Aug 2025 12:43:18:333,systemuser,14 Aug 2025 11:15:07:547,systemuser,14 Aug 2025 11:15:07:547,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.333,20250814 11:15:07.547,20250814 11:15:07.547,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,15254069,Closed,systemuser,08 Aug 2025 12:43:18:347,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.347,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,15254070,Closed,systemuser,08 Aug 2025 12:43:18:357,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.357,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,15254071,Closed,systemuser,08 Aug 2025 12:43:18:367,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.367,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Was the sample collected?,Site from Medical Reviewer,15334261,Closed,inayath1,14 Aug 2025 03:13:01:417,v.smidkova1,14 Aug 2025 11:15:30:340,inayath1,14 Aug 2025 14:08:38:730,,0,0,Eligibility: Please update the UDS results as per completion guidelines.,Updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250814 03:13:01.417,20250814 11:15:30.340,20250814 14:08:38.730,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,15254072,Closed,systemuser,08 Aug 2025 12:43:18:377,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.377,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,15254074,Closed,systemuser,08 Aug 2025 12:43:18:400,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.400,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,15254073,Closed,systemuser,08 Aug 2025 12:43:18:390,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.390,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,15254075,Closed,systemuser,08 Aug 2025 12:43:18:413,systemuser,14 Aug 2025 11:15:07:550,systemuser,14 Aug 2025 11:15:07:550,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:43:18.413,20250814 11:15:07.550,20250814 11:15:07.550,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,,Were all eligibility criteria met?,DM,15808421,Closed,shyamaprasad972,04 Sep 2025 07:38:33:933,v.smidkova1,11 Sep 2025 11:22:45:480,shyamaprasad972,12 Sep 2025 07:16:06:383,,7,1,"DM: As the subject is screen failure, kindly verify and update the data as appropriate in the form Inclusion/Exclusion Criteria.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 07:38:33.933,20250911 11:22:45.480,20250912 07:16:06.383,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,,Were all eligibility criteria met?,DM,15938923 (15808421),Closed,shyamaprasad972,12 Sep 2025 07:16:06:517,v.smidkova1,18 Sep 2025 09:22:40:183,Ashwini201,19 Sep 2025 10:10:31:447,,6,1,RQ-DM1: Thank you for the response. Please verify and update the data on 'What was the category of the criterion?' and 'Criterion ID' fields.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250912 07:16:06.517,20250918 09:22:40.183,20250919 10:10:31.447,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,"If No, enter below information about criteria not satisfied/met (click Add New Log Line to enter more than one criterion)What was the category of the criterion?",Auto,15921654,Closed,systemuser,11 Sep 2025 11:19:16:680,systemuser,18 Sep 2025 09:22:21:053,systemuser,18 Sep 2025 09:22:21:057,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250911 11:19:16.680,20250918 09:22:21.053,20250918 09:22:21.057,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,Criterion ID,Auto,15921655,Closed,systemuser,11 Sep 2025 11:19:16:700,systemuser,18 Sep 2025 09:22:21:057,systemuser,18 Sep 2025 09:22:21:057,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250911 11:19:16.700,20250918 09:22:21.057,20250918 09:22:21.057,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15254054,Closed,systemuser,08 Aug 2025 12:42:25:467,systemuser,08 Aug 2025 12:42:34:910,systemuser,08 Aug 2025 12:42:34:913,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 12:42:25.467,20250808 12:42:34.910,20250808 12:42:34.913,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080003,Screen Failed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15526219,Closed,systemuser,22 Aug 2025 10:44:46:940,m.deif2,22 Aug 2025 10:44:58:960,shyamaprasad972,08 Sep 2025 13:02:05:540,,0,17,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",NA,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 10:44:46.940,20250822 10:44:58.960,20250908 13:02:05.540,94,335,335,9,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15661636,Closed,systemuser,28 Aug 2025 08:54:17:747,systemuser,28 Aug 2025 08:54:46:123,systemuser,28 Aug 2025 08:54:46:127,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 08:54:17.747,20250828 08:54:46.123,20250828 08:54:46.127,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,1. Loss of appetite,Auto,16432143,Closed,systemuser,16 Oct 2025 06:42:47:973,systemuser,16 Oct 2025 06:44:14:697,systemuser,16 Oct 2025 06:44:14:697,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:47.973,20251016 06:44:14.697,20251016 06:44:14.697,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,2. Nausea - Vomiting,Auto,16432144,Closed,systemuser,16 Oct 2025 06:42:47:990,systemuser,16 Oct 2025 06:44:14:697,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:47.990,20251016 06:44:14.697,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,3. Diarrhea,Auto,16432145,Closed,systemuser,16 Oct 2025 06:42:48:000,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.000,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"4. Anxiety, Nervousness",Auto,16432146,Closed,systemuser,16 Oct 2025 06:42:48:010,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.010,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,16432147,Closed,systemuser,16 Oct 2025 06:42:48:020,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.020,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"6. Dysphoric Mood, Depression",Auto,16432148,Closed,systemuser,16 Oct 2025 06:42:48:037,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.037,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,7. Insomnia,Auto,16432149,Closed,systemuser,16 Oct 2025 06:42:48:053,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.053,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,16432150,Closed,systemuser,16 Oct 2025 06:42:48:063,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.063,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,9. Poor Coordination,Auto,16432151,Closed,systemuser,16 Oct 2025 06:42:48:073,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.073,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"10. Restlessness, Agitation",Auto,16432152,Closed,systemuser,16 Oct 2025 06:42:48:083,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.083,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,11. Diaphoresis,Auto,16432153,Closed,systemuser,16 Oct 2025 06:42:48:097,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.097,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,12. Tremor - Tremulousness,Auto,16432154,Closed,systemuser,16 Oct 2025 06:42:48:107,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.107,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,13. Dizziness - Lightheadedness,Auto,16432155,Closed,systemuser,16 Oct 2025 06:42:48:113,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.113,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,14. Headaches,Auto,16432156,Closed,systemuser,16 Oct 2025 06:42:48:127,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.127,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,15. Muscle Aches or Stiffness,Auto,16432157,Closed,systemuser,16 Oct 2025 06:42:48:133,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.133,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,16. Weakness,Auto,16432158,Closed,systemuser,16 Oct 2025 06:42:48:143,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.143,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"17. Increased acuity for sound, smell, touch or pain",Auto,16432159,Closed,systemuser,16 Oct 2025 06:42:48:153,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.153,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,18. Paresthesias,Auto,16432160,Closed,systemuser,16 Oct 2025 06:42:48:163,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.163,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"19. Difficulty concentrating, remembering",Auto,16432161,Closed,systemuser,16 Oct 2025 06:42:48:173,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.173,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,"20. Depersonalization, Derealization",Auto,16432162,Closed,systemuser,16 Oct 2025 06:42:48:183,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:48.183,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,16432142,Closed,systemuser,16 Oct 2025 06:42:47:940,systemuser,16 Oct 2025 06:44:14:700,systemuser,16 Oct 2025 06:44:14:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:42:47.940,20251016 06:44:14.700,20251016 06:44:14.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 7-14 Days After (1),Alcohol Test,0/0/N,,Collection Date,Auto,16956333,Closed,systemuser,12 Nov 2025 13:13:18:153,v.smidkova1,12 Nov 2025 13:30:33:263,Ashwini201,24 Feb 2026 10:11:27:340,,0,104,"The 'Collection Date' is after the Disposition Date (""<core:link text='datapoint.uservalue' formoid='DS_GL_900' folderoid='SCRDS' fieldoid='DSSTDAT' />"") on the ""<core:link text='Trial Disposition' formoid='DS_GL_900' folderoid='SCRDS' />"" form. Please resolve.",The data is correct. The patient completed his studies early and attended the FU visit.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 13:13:18.153,20251112 13:30:33.263,20260224 10:11:27.340,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 7-14 Days After (1),Drug Testing,0/0/N,,Collection Time,Auto,16956534,Closed,systemuser,12 Nov 2025 13:17:12:390,systemuser,12 Nov 2025 13:29:00:007,systemuser,12 Nov 2025 13:29:00:007,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 13:17:12.390,20251112 13:29:00.007,20251112 13:29:00.007,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 7-14 Days After (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,16847288,Closed,systemuser,07 Nov 2025 07:24:18:810,systemuser,07 Nov 2025 11:03:03:823,systemuser,07 Nov 2025 11:03:03:827,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 07:24:18.810,20251107 11:03:03.823,20251107 11:03:03.827,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 7-14 Days After (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,16847289,Closed,systemuser,07 Nov 2025 07:24:18:857,systemuser,07 Nov 2025 11:03:04:093,systemuser,07 Nov 2025 11:03:04:093,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 07:24:18.857,20251107 11:03:04.093,20251107 11:03:04.093,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Follow-up 7-14 Days After (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16847209,Closed,systemuser,07 Nov 2025 07:14:39:353,systemuser,07 Nov 2025 07:14:43:433,systemuser,07 Nov 2025 07:14:43:433,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 07:14:39.353,20251107 07:14:43.433,20251107 07:14:43.433,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251112 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,16956332,Closed,systemuser,12 Nov 2025 13:13:18:083,systemuser,12 Nov 2025 14:16:07:983,systemuser,12 Nov 2025 14:16:08:113,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 13:13:18.083,20251112 14:16:07.983,20251112 14:16:08.113,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933183,Closed,systemuser,20 May 2026 12:01:51:370,,,systemuser,20 May 2026 12:02:16:653,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:01:51.370,,20260520 12:02:16.653,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16421512,Closed,systemuser,15 Oct 2025 12:53:17:233,,,systemuser,16 Oct 2025 08:07:03:973,,,1,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 12:53:17.233,,20251016 08:07:03.973,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/N,,What was the subject's primary reason for treatment discontinuation/completion?,Auto,16540461,Closed,systemuser,23 Oct 2025 09:13:11:747,systemuser,23 Oct 2025 09:15:20:790,systemuser,23 Oct 2025 09:15:20:790,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 09:13:11.747,20251023 09:15:20.790,20251023 09:15:20.790,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/N,,What was the subject's primary reason for treatment discontinuation/completion?,Site from Medical Reviewer,16610716,Closed,joetrombello1,27 Oct 2025 19:51:27:367,v.smidkova1,29 Oct 2025 10:46:09:230,joetrombello1,29 Oct 2025 12:44:01:413,,2,0,"medical reviewer: Please review all available options to choose the most specific reason that will generalize across other similar trial scenarios, avoiding &quot;other&quot; per study conventions whenever possible. Please revise as necessary. Please also clarify if known why the pt. decided to end the study early.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 19:51:27.367,20251029 10:46:09.230,20251029 12:44:01.413,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/N,,What was the subject's primary reason for treatment discontinuation/completion?,DM,19632441,Closed,Juhita@ksha4,23 Mar 2026 05:39:38:250,v.smidkova1,25 Mar 2026 12:19:07:557,Juhita@ksha4,25 Mar 2026 15:08:00:360,,2,0,Medical Review I-3093903: Patient completed all of Part 1 and by study conventions may be considered a completer. Please review and revise.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 05:39:38.250,20260325 12:19:07.557,20260325 15:08:00.360,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/N,,Treatment Disposition Date,DM,16517127,Closed,Juhita@ksha4,22 Oct 2025 07:16:30:700,v.smidkova1,23 Oct 2025 09:15:28:713,Juhita@ksha4,24 Oct 2025 11:17:44:700,,1,1,Medical Review I-273540: Please complete treatment disposition page and once available also complete trial disposition as well.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 07:16:30.700,20251023 09:15:28.713,20251024 11:17:44.700,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/N,,Treatment Disposition Date,Site from Medical Reviewer,16855136,Closed,ewajs1,07 Nov 2025 12:02:09:037,v.smidkova1,12 Nov 2025 13:12:31:357,ewajs1,01 Jan 2026 17:20:38:063,,5,50,The date of treatment disposition should be aligned with the visit when the participant decided to withdrew consent (visit 8). Please verify,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 12:02:09.037,20251112 13:12:31.357,20260101 17:20:38.063,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,What was the subject's status? (Derived field),Site from Medical Reviewer,16855019,Closed,ewajs1,07 Nov 2025 11:59:14:453,v.smidkova1,12 Nov 2025 13:13:29:423,ewajs1,01 Jan 2026 17:22:43:300,,5,50,Please complete the trial disposition page.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 11:59:14.453,20251112 13:13:29.423,20260101 17:22:43.300,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,What was the subject's status? (Derived field),Site from Medical Reviewer,18273206 (16855019),Cancelled,ewajs1,01 Jan 2026 17:22:43:413,,,ewajs1,01 Jan 2026 17:22:54:563,,,,Note that trial disposition is different from treatment disposition. Trial disposition date is consistent with the last Follow up visit.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260101 17:22:43.413,,20260101 17:22:54.563,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,What was the subject's primary reason for trial discontinuation/completion?,DM,19633487,Closed,JThoma858,23 Mar 2026 06:34:59:090,v.smidkova1,25 Mar 2026 12:18:32:233,JThoma858,26 Mar 2026 05:38:55:673,,2,1,Medical Review  I-3093899:  Response does not align with study expectations when patient completes the second f/u visit and is therefore a completer. Please revise.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 06:34:59.090,20260325 12:18:32.233,20260326 05:38:55.673,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,17287566,Closed,Ashwini201,25 Nov 2025 14:17:37:240,m.deif2,27 Nov 2025 09:53:36:367,Ashwini201,28 Nov 2025 09:47:56:390,,2,1,"DM: Please verify and update the data on all blank forms of Screening to end of study, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:17:37.240,20251127 09:53:36.367,20251128 09:47:56.390,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,17317651,Closed,SanchariDutta@025,26 Nov 2025 10:56:44:080,m.deif2,27 Nov 2025 09:53:45:560,SanchariDutta@025,09 Dec 2025 10:57:29:367,,1,12,"DM: 'Follow-up 7-14 Days After' visit is completed on 05-Nov-2025, however trial disposition date is reported as 14-Oct-2025. Please verify and update the disposition date as appropriate, else clarify.",patient outside the window due to AE,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251126 10:56:44.080,20251127 09:53:45.560,20251209 10:57:29.367,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,17782882 (17317651),Closed,SanchariDutta@025,09 Dec 2025 10:57:29:523,v.smidkova1,11 Dec 2025 07:34:08:910,SanchariDutta@025,24 Feb 2026 10:20:56:067,,2,75,"RQ-DM1: Thank you for your response. However, 'Follow-up 7-14 Days After' visit date given as 05-Nov-2025 which is after the trial disposition date 14-Oct-2025. Kindly review and update the disposition date as appropriate, else clarify.",data is according to source documentation,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 10:57:29.523,20251211 07:34:08.910,20260224 10:20:56.067,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,18232656,Closed,Ashwini201,29 Dec 2025 07:09:33:400,v.smidkova1,02 Jan 2026 07:49:16:423,Ashwini201,02 Jan 2026 12:02:32:750,,4,0,"DM: Please reactivate and update the data on Change in Background Antidepressant form, else clarify. ",done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 07:09:33.400,20260102 07:49:16.423,20260102 12:02:32.750,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,Site from Medical Reviewer,18273212,Closed,ewajs1,01 Jan 2026 17:23:54:403,v.smidkova1,02 Jan 2026 07:50:18:153,ewajs1,12 Feb 2026 15:14:11:987,,1,41,Note that trial disposition is different than treatment disposition. Trial disposition date should be consistent with the last Follow up visit.,"cannot be changed, data is frozen",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260101 17:23:54.403,20260102 07:50:18.153,20260212 15:14:11.987,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,Site from Medical Reviewer,18914103 (18273212),Closed,ewajs1,12 Feb 2026 15:14:11:760,v.smidkova1,17 Feb 2026 07:45:28:590,ewajs1,22 Apr 2026 09:51:17:917,,5,64,The request to unfreeze this page was sent,"date changed November 5, 2025",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 15:14:11.760,20260217 07:45:28.590,20260422 09:51:17.917,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Site from Medical Reviewer,15749090,Cancelled,inayath1,02 Sep 2025 05:10:50:850,,,inayath1,10 Sep 2025 07:11:48:963,,,,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 05:10:50.850,,20250910 07:11:48.963,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,15749085,Cancelled,inayath1,02 Sep 2025 05:09:59:937,,,inayath1,11 Sep 2025 08:29:59:733,,,,Eligibility: Please confirm whether UDS was done at screening. If done please update the result in 'Drug Testing' form in EDC. ,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 05:09:59.937,,20250911 08:29:59.733,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17287584,Closed,Ashwini201,25 Nov 2025 14:18:31:690,m.deif2,27 Nov 2025 09:50:45:817,Ashwini201,28 Nov 2025 09:48:23:770,,2,1,DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:18:31.690,20251127 09:50:45.817,20251128 09:48:23.770,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening Visit 1,General Medical History,0/0/N,11,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,15748904,Closed,inayath1,02 Sep 2025 05:02:48:723,r.gregar1,03 Sep 2025 06:24:44:207,inayath1,08 Sep 2025 05:36:27:690,,1,5,Eligibility: Subject is having an ongoing medical history of Anxiety since 2024. Please confirm that Anxiety is not the patient's current primary psychiatric diagnosis per exclusion #12.,it is secondary to MDD,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 05:02:48.723,20250903 06:24:44.207,20250908 05:36:27.690,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Screening Visit 1,General Medical History,0/0/N,11,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,15748935,Closed,inayath1,02 Sep 2025 05:03:11:973,r.gregar1,03 Sep 2025 06:24:50:273,meghal.choksi@iqvia.com1,18 Sep 2025 11:12:37:123,,1,15,"Eligibility: Kindly clarify if the reported MH is a primary psychiatric condition or secondary to MDD, update as appropriate. ",it is secondary to MDD,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 05:03:11.973,20250903 06:24:50.273,20250918 11:12:37.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,15981047,Closed,systemuser,16 Sep 2025 10:53:54:147,,,systemuser,17 Sep 2025 12:51:27:090,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250916 10:53:54.147,,20250917 12:51:27.090,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,16004861,Closed,systemuser,17 Sep 2025 12:01:30:647,systemuser,18 Sep 2025 05:52:24:513,systemuser,18 Sep 2025 05:52:24:513,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250917 12:01:30.647,20250918 05:52:24.513,20250918 05:52:24.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 3 Part 1 Baseline,Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,16006175,Closed,systemuser,17 Sep 2025 12:50:06:670,systemuser,25 Sep 2025 07:33:19:723,systemuser,25 Sep 2025 07:33:19:727,,8,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250917 12:50:06.670,20250925 07:33:19.723,20250925 07:33:19.727,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16004771,Closed,systemuser,17 Sep 2025 11:58:02:870,systemuser,17 Sep 2025 11:58:20:420,systemuser,17 Sep 2025 11:58:20:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250917 11:58:02.870,20250917 11:58:20.420,20250917 11:58:20.423,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,1. Reported Sadness,Auto,16208703,Closed,systemuser,30 Sep 2025 09:19:04:057,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.057,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,2. Apparent Sadness,Auto,16208704,Closed,systemuser,30 Sep 2025 09:19:04:067,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.067,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,3. Inner Tension,Auto,16208705,Closed,systemuser,30 Sep 2025 09:19:04:073,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.073,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,4. Reduced Sleep,Auto,16208706,Closed,systemuser,30 Sep 2025 09:19:04:083,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.083,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,5. Reduced Appetite,Auto,16208707,Closed,systemuser,30 Sep 2025 09:19:04:093,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.093,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,6. Concentration Difficulties,Auto,16208708,Closed,systemuser,30 Sep 2025 09:19:04:103,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.103,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,7. Lassitude,Auto,16208709,Closed,systemuser,30 Sep 2025 09:19:04:113,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.113,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,8. Inability to Feel,Auto,16208710,Closed,systemuser,30 Sep 2025 09:19:04:120,systemuser,30 Sep 2025 09:20:07:520,systemuser,30 Sep 2025 09:20:07:520,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.120,20250930 09:20:07.520,20250930 09:20:07.520,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,9. Pessimistic Thoughts,Auto,16208711,Closed,systemuser,30 Sep 2025 09:19:04:130,systemuser,30 Sep 2025 09:20:07:523,systemuser,30 Sep 2025 09:20:07:523,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.130,20250930 09:20:07.523,20250930 09:20:07.523,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,16208712,Closed,systemuser,30 Sep 2025 09:19:04:143,systemuser,30 Sep 2025 09:20:07:523,systemuser,30 Sep 2025 09:20:07:523,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.143,20250930 09:20:07.523,20250930 09:20:07.523,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,16208713,Closed,systemuser,30 Sep 2025 09:19:04:167,systemuser,30 Sep 2025 09:20:07:760,systemuser,30 Sep 2025 09:20:07:760,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.167,20250930 09:20:07.760,20250930 09:20:07.760,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Rater's Initials,Auto,16208702,Closed,systemuser,30 Sep 2025 09:19:04:043,systemuser,30 Sep 2025 09:20:07:537,systemuser,30 Sep 2025 09:20:07:537,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.043,20250930 09:20:07.537,20250930 09:20:07.537,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Was the collection date the same as the visit date?,Auto,16208701,Closed,systemuser,30 Sep 2025 09:19:04:020,systemuser,30 Sep 2025 09:20:07:540,systemuser,30 Sep 2025 09:20:07:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 09:19:04.020,20250930 09:20:07.540,20250930 09:20:07.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16224171,Closed,systemuser,01 Oct 2025 08:49:24:057,systemuser,01 Oct 2025 08:49:39:077,systemuser,01 Oct 2025 08:49:39:077,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 08:49:24.057,20251001 08:49:39.077,20251001 08:49:39.077,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 7 Part 1 (1),Date of Visit,0/0/N,,Subject's Status,Auto,16421495,Closed,systemuser,15 Oct 2025 12:51:42:193,systemuser,15 Oct 2025 12:52:56:333,systemuser,15 Oct 2025 12:52:56:333,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 12:51:42.193,20251015 12:52:56.333,20251015 12:52:56.333,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Alcohol Test,0/0/N,,Alcohol Test Result,Auto,16421726,Closed,systemuser,15 Oct 2025 13:00:52:203,systemuser,15 Oct 2025 13:01:23:270,systemuser,15 Oct 2025 13:01:23:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:52.203,20251015 13:01:23.270,20251015 13:01:23.270,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Alcohol Test,0/0/N,,Collection Date,Auto,16421725,Closed,systemuser,15 Oct 2025 13:00:52:180,systemuser,15 Oct 2025 13:01:23:273,systemuser,15 Oct 2025 13:01:23:273,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:52.180,20251015 13:01:23.273,20251015 13:01:23.273,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Date of Visit,0/0/N,,Subject's Status,Auto,19696234,Closed,systemuser,25 Mar 2026 12:18:27:550,v.smidkova1,25 Mar 2026 12:19:51:997,Ashwini201,26 Mar 2026 15:35:49:597,,0,1,"Trial Disposition is ""Completed"" on the Trial Disposition (Completion/ Discontinuation) form, however, the Subject Status on the Last Date of Visit is not ""Completed Study"". Please resolve.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 12:18:27.550,20260325 12:19:51.997,20260326 15:35:49.597,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,16421680,Closed,systemuser,15 Oct 2025 13:00:12:817,systemuser,15 Oct 2025 13:00:45:507,systemuser,15 Oct 2025 13:00:45:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.817,20251015 13:00:45.507,20251015 13:00:45.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,16421681,Closed,systemuser,15 Oct 2025 13:00:12:827,systemuser,15 Oct 2025 13:00:45:513,systemuser,15 Oct 2025 13:00:45:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.827,20251015 13:00:45.513,20251015 13:00:45.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,16421682,Closed,systemuser,15 Oct 2025 13:00:12:840,systemuser,15 Oct 2025 13:00:45:513,systemuser,15 Oct 2025 13:00:45:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.840,20251015 13:00:45.513,20251015 13:00:45.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,16421683,Closed,systemuser,15 Oct 2025 13:00:12:850,systemuser,15 Oct 2025 13:00:45:513,systemuser,15 Oct 2025 13:00:45:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.850,20251015 13:00:45.513,20251015 13:00:45.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,16421684,Closed,systemuser,15 Oct 2025 13:00:12:857,systemuser,15 Oct 2025 13:00:45:513,systemuser,15 Oct 2025 13:00:45:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.857,20251015 13:00:45.513,20251015 13:00:45.513,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,16421679,Closed,systemuser,15 Oct 2025 13:00:12:803,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.803,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,16421685,Closed,systemuser,15 Oct 2025 13:00:12:867,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.867,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,16421687,Closed,systemuser,15 Oct 2025 13:00:12:883,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.883,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,16421686,Closed,systemuser,15 Oct 2025 13:00:12:873,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.873,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,16421688,Closed,systemuser,15 Oct 2025 13:00:12:897,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.897,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,16421678,Closed,systemuser,15 Oct 2025 13:00:12:763,systemuser,15 Oct 2025 13:00:45:540,systemuser,15 Oct 2025 13:00:45:540,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:00:12.763,20251015 13:00:45.540,20251015 13:00:45.540,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Mobility,Auto,16421768,Closed,systemuser,15 Oct 2025 13:04:02:600,systemuser,15 Oct 2025 13:04:26:120,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.600,20251015 13:04:26.120,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Self-Care,Auto,16421769,Closed,systemuser,15 Oct 2025 13:04:02:610,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.610,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Usual Activities,Auto,16421770,Closed,systemuser,15 Oct 2025 13:04:02:620,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.620,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Pain/Discomfort,Auto,16421771,Closed,systemuser,15 Oct 2025 13:04:02:630,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.630,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Anxiety/Depression,Auto,16421772,Closed,systemuser,15 Oct 2025 13:04:02:640,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.640,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Your health today,Auto,16421773,Closed,systemuser,15 Oct 2025 13:04:02:650,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.650,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Your health today,Auto,16421778,Closed,systemuser,15 Oct 2025 13:04:26:193,,,systemuser,15 Oct 2025 13:04:35:737,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:26.193,,20251015 13:04:35.737,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Was the collection date the same as the visit date?,Auto,16421767,Closed,systemuser,15 Oct 2025 13:04:02:580,systemuser,15 Oct 2025 13:04:26:123,systemuser,15 Oct 2025 13:04:26:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 13:04:02.580,20251015 13:04:26.123,20251015 13:04:26.123,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080004,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16421523,Closed,systemuser,15 Oct 2025 12:55:02:147,systemuser,15 Oct 2025 12:56:17:300,systemuser,15 Oct 2025 12:56:17:303,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 12:55:02.147,20251015 12:56:17.300,20251015 12:56:17.303,94,335,335,25,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Is the adverse event still ongoing?,DM,17675349,Closed,Juhita@ksha4,05 Dec 2025 13:28:20:067,v.smidkova1,18 Dec 2025 09:42:03:070,Juhita@ksha4,26 Dec 2025 19:17:00:053,,13,8,Medical Review I-941083: Kindly clarify if AE is ongoing else consider updating end date.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:28:20.067,20251218 09:42:03.070,20251226 19:17:00.053,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Action Taken with Study Treatment,DM,17675379,Closed,Juhita@ksha4,05 Dec 2025 13:29:52:883,v.smidkova1,18 Dec 2025 09:42:01:263,Juhita@ksha4,26 Dec 2025 19:15:31:983,,13,8,Medical Review I-941085: Start date for the AE was before the first dose of IP. Kindly update the Correct action taken.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:29:52.883,20251218 09:42:01.263,20251226 19:15:31.983,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,End Date,Auto,18085744,Closed,systemuser,18 Dec 2025 09:40:49:793,,,systemuser,18 Dec 2025 09:41:09:777,,,0,The 'End Date' is before the 'Start Date'. Please resolve.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 09:40:49.793,,20251218 09:41:09.777,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,End Date,Auto,18085745,Closed,systemuser,18 Dec 2025 09:40:49:803,systemuser,18 Dec 2025 09:41:29:943,systemuser,18 Dec 2025 09:41:29:963,,0,0,"If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 09:40:49.803,20251218 09:41:29.943,20251218 09:41:29.963,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,"If yes, date of stabilization",Auto,16333580,Closed,systemuser,09 Oct 2025 09:02:28:810,systemuser,15 Oct 2025 12:58:14:253,systemuser,15 Oct 2025 12:58:14:257,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 09:02:28.810,20251015 12:58:14.253,20251015 12:58:14.257,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,"If Not recovered or Not resolved, has the event stabilized?",Auto,16333579,Closed,systemuser,09 Oct 2025 09:02:28:803,systemuser,15 Oct 2025 12:58:14:347,systemuser,15 Oct 2025 12:58:14:347,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 09:02:28.803,20251015 12:58:14.347,20251015 12:58:14.347,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,What is the adverse event term?,Site from Medical Reviewer,16507660,Closed,ewajs1,21 Oct 2025 15:33:54:550,v.smidkova1,29 Oct 2025 14:10:30:540,ewajs1,05 Nov 2025 11:41:06:857,,8,7,"Overactive bladder is reported as a medical history, Please verify if this is a worsening of overactive bladder symptoms and report as such",is it finished,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251021 15:33:54.550,20251029 14:10:30.540,20251105 11:41:06.857,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,What is the adverse event term?,Site from Medical Reviewer,16801609 (16507660),Closed,ewajs1,05 Nov 2025 11:41:06:980,v.smidkova1,12 Nov 2025 13:24:15:443,ewajs1,01 Jan 2026 17:26:08:643,,7,50,"Medical history of overactive bladder is marked as ongoing. If so the condition was present prior to the study and may not be an adverse event, unless it is a worsening. Please verify",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 11:41:06.980,20251112 13:24:15.443,20260101 17:26:08.643,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Outcome,DM,19081450,Closed,SanchariDutta@025,19 Feb 2026 13:45:11:343,v.smidkova1,26 Feb 2026 07:45:03:873,JThoma858,04 Mar 2026 09:48:22:837,,7,6,Medical Review I-1942371: End date was provided for the AE but outcome was not recovered. Kindly update the outcome correctly.,updated - AE ongoing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260219 13:45:11.343,20260226 07:45:03.873,20260304 09:48:22.837,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,Outcome,DM,19297871 (19081450),Closed,JThoma858,04 Mar 2026 09:48:23:143,v.smidkova1,04 Mar 2026 12:13:33:643,JThoma858,09 Mar 2026 10:14:18:517,,0,5,RQ-MR1: Please refer the completion guideline and update the end date or Is the adverse event still ongoing? field .Thank you,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260304 09:48:23.143,20260304 12:13:33.643,20260309 10:14:18.517,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,3,Outcome,DM,19751869,Closed,JThoma858,30 Mar 2026 05:52:45:520,v.smidkova1,09 Apr 2026 06:33:26:093,JThoma858,10 Apr 2026 06:09:42:547,,10,1,Medical Review I-3113164 : The end date is updated however the outcome is still &quot;not recovered or not resolved&quot; . Kindly recheck and update.,outcome added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 05:52:45.520,20260409 06:33:26.093,20260410 06:09:42.547,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,3,End Date,Auto,19697413,Closed,systemuser,25 Mar 2026 13:01:49:897,systemuser,25 Mar 2026 13:01:57:937,systemuser,25 Mar 2026 13:01:57:953,,0,0,"If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 13:01:49.897,20260325 13:01:57.937,20260325 13:01:57.953,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,3,Is the adverse event still ongoing?,DM,19692286,Closed,JThoma858,25 Mar 2026 09:56:40:763,v.smidkova1,25 Mar 2026 13:02:10:437,JThoma858,26 Mar 2026 05:40:05:567,,0,1,Medical Review  I-3113164 : Kindly clarify if AE is ongoing else consider updating end date,end day added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 09:56:40.763,20260325 13:02:10.437,20260326 05:40:05.567,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15965349,Closed,systemuser,15 Sep 2025 12:48:49:557,systemuser,15 Sep 2025 12:49:15:967,systemuser,15 Sep 2025 12:49:15:970,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250915 12:48:49.557,20250915 12:49:15.967,20250915 12:49:15.970,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Route,DM,16079800,Closed,Juhita@ksha4,23 Sep 2025 08:35:24:740,v.smidkova1,25 Sep 2025 07:40:48:130,Juhita@ksha4,26 Sep 2025 06:28:39:007,,2,1,Medical Review I-120228: Please review and revise if necessary the route of administration.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250923 08:35:24.740,20250925 07:40:48.130,20250926 06:28:39.007,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,4,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15965535,Closed,systemuser,15 Sep 2025 12:52:55:733,systemuser,15 Sep 2025 12:53:44:010,systemuser,15 Sep 2025 12:53:44:010,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250915 12:52:55.733,20250915 12:53:44.010,20250915 12:53:44.010,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Route,Site from Medical Reviewer,16801961,Closed,ewajs1,05 Nov 2025 11:57:42:463,m.deif2,07 Nov 2025 11:04:10:437,ewajs1,01 Jan 2026 17:19:53:137,,2,55,Please verify the route of administration.,data corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 11:57:42.463,20251107 11:04:10.437,20260101 17:19:53.137,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,6,Route,Site from Medical Reviewer,16041655,Closed,inayath1,19 Sep 2025 06:22:56:347,v.smidkova1,25 Sep 2025 07:44:09:457,inayath1,27 Sep 2025 14:39:23:180,,6,2,Eligibility: Please recheck and update the correct route.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 06:22:56.347,20250925 07:44:09.457,20250927 14:39:23.180,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,8,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15965731,Closed,systemuser,15 Sep 2025 12:59:18:317,systemuser,15 Sep 2025 12:59:33:213,systemuser,15 Sep 2025 12:59:33:217,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250915 12:59:18.317,20250915 12:59:33.213,20250915 12:59:33.217,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,9,"If indication is 'Adverse Event,' choose the primary corresponding AE log line(s), start date(s), and term(s)AE log line, start date, and term",Auto,16333702,Closed,systemuser,09 Oct 2025 09:07:23:800,,,systemuser,09 Oct 2025 09:07:45:267,,,0,"The same 'AE log line, start date, and term' is selected more than once. Please resolve.",QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 09:07:23.800,,20251009 09:07:45.267,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,9,"If indication is 'Adverse Event,' choose the primary corresponding AE log line(s), start date(s), and term(s)AE log line, start date, and term",Auto,16956790,Closed,systemuser,12 Nov 2025 13:24:10:457,v.smidkova1,13 Nov 2025 09:24:13:943,shyamaprasad972,14 Nov 2025 14:59:18:083,,1,1,The selected logline has been modified from  '#001 > 19SEP2025 > OVERACTIVE BLADDER' to '#001 > 19SEP2025 > WORSENING OVERACTIVE BLADDER' on 'Adverse Events/Serious Aes' form. Please either confirm by responding in the query answer box or re-select the correct Adverse Events/Serious Aes from the drop-down.#DSL#,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 13:24:10.457,20251113 09:24:13.943,20251114 14:59:18.083,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,9,"If No, or if selected medication/therapy is Other - Medication or Therapy",Auto,16333706,Closed,systemuser,09 Oct 2025 09:07:45:577,systemuser,09 Oct 2025 09:08:55:417,systemuser,09 Oct 2025 09:08:55:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 09:07:45.577,20251009 09:08:55.417,20251009 09:08:55.427,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 1 Day After (1),Date of Visit,0/0/N,,Subject's Status,Auto,18560972,Closed,systemuser,21 Jan 2026 13:55:19:577,systemuser,21 Jan 2026 13:56:58:047,systemuser,21 Jan 2026 13:56:58:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260121 13:55:19.577,20260121 13:56:58.047,20260121 13:56:58.053,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 1 Day After (1),Date of Visit,0/0/N,,Did this visit occur?,Auto,18560971,Closed,systemuser,21 Jan 2026 13:55:19:557,systemuser,21 Jan 2026 13:56:58:597,systemuser,21 Jan 2026 13:56:58:597,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260121 13:55:19.557,20260121 13:56:58.597,20260121 13:56:58.597,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 1 Day After (1),Date of Visit,0/0/N,,Visit Start Date,Auto,18560973,Closed,systemuser,21 Jan 2026 13:55:19:587,systemuser,21 Jan 2026 13:56:59:203,systemuser,21 Jan 2026 13:56:59:203,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260121 13:55:19.587,20260121 13:56:59.203,20260121 13:56:59.203,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 1 Day After (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,18477049,Closed,systemuser,16 Jan 2026 09:42:29:470,systemuser,16 Jan 2026 09:42:35:710,systemuser,16 Jan 2026 09:42:35:710,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 09:42:29.470,20260116 09:42:35.710,20260116 09:42:35.710,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 7-14 Days After (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19556451,Closed,Ashwini201,17 Mar 2026 11:23:06:813,v.smidkova1,19 Mar 2026 07:45:57:007,Ashwini201,25 Mar 2026 08:48:08:193,,2,6,DM: Kindly inactivate all the End of study visit forms as the data is duplicating with this visit.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 11:23:06.813,20260319 07:45:57.007,20260325 08:48:08.193,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 7-14 Days After (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19690247 (19556451),Closed,Ashwini201,25 Mar 2026 08:48:08:413,v.smidkova1,25 Mar 2026 12:24:24:557,Ashwini201,26 Mar 2026 15:37:04:670,,0,1,RQ-DM1: Thank you for the response however End of Study data is not inactivated.,done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 08:48:08.413,20260325 12:24:24.557,20260326 15:37:04.670,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 7-14 Days After (1),Patient Health Questionnaire - 9 Item,0/0/V,,Reason Not Done,Auto,19298233,Closed,systemuser,04 Mar 2026 10:00:11:767,systemuser,04 Mar 2026 10:00:30:697,systemuser,04 Mar 2026 10:00:30:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260304 10:00:11.767,20260304 10:00:30.697,20260304 10:00:30.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Follow-up 7-14 Days After (1),Patient Health Questionnaire - 9 Item,0/0/V,,"If Other, specify",Auto,19298234,Closed,systemuser,04 Mar 2026 10:00:30:757,systemuser,04 Mar 2026 10:00:35:910,systemuser,04 Mar 2026 10:00:35:913,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260304 10:00:30.757,20260304 10:00:35.910,20260304 10:00:35.913,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260122 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18571918,Closed,systemuser,22 Jan 2026 06:51:42:817,systemuser,22 Jan 2026 06:58:00:803,systemuser,22 Jan 2026 06:58:00:923,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 06:51:42.817,20260122 06:58:00.803,20260122 06:58:00.923,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933189,Closed,systemuser,20 May 2026 12:02:53:063,,,systemuser,20 May 2026 12:03:14:700,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:02:53.063,,20260520 12:03:14.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,17060223,Closed,systemuser,18 Nov 2025 09:42:33:400,,,systemuser,21 Nov 2025 10:59:40:713,,,3,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 09:42:33.400,,20251121 10:59:40.713,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Treatment Disposition - Induction,0/0/V,,What was the subject's primary reason for treatment discontinuation/completion?,Site from Medical Reviewer,18582971,Closed,joetrombello1,22 Jan 2026 14:42:24:447,v.smidkova1,23 Jan 2026 08:57:55:987,joetrombello1,23 Jan 2026 15:02:46:297,,1,0,medical reviewer: Pls review and revise response in line with study guidance when a pt. does not meet response criteria to move onto the next phase.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 14:42:24.447,20260123 08:57:55.987,20260123 15:02:46.297,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Treatment Disposition - Induction,0/0/V,,Treatment Disposition Date,Site from Medical Reviewer,18535682,Closed,joetrombello1,20 Jan 2026 13:34:26:620,v.smidkova1,22 Jan 2026 06:52:38:077,joetrombello1,22 Jan 2026 14:41:23:003,,2,0,medical reviewer: Pls complete.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 13:34:26.620,20260122 06:52:38.077,20260122 14:41:23.003,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Treatment Disposition - Induction,0/0/V,,Treatment Disposition Date,Site from Medical Reviewer,18582957 (18535682),Closed,joetrombello1,22 Jan 2026 14:41:23:233,v.smidkova1,23 Jan 2026 08:57:07:033,joetrombello1,23 Jan 2026 15:04:40:640,,1,0,"medical reviewer: Pls verify date in line with CCG guidance below. Please review and revise as necessary. Record the date the subject completed treatment or the date the decision was taken to discontinue the subject from the treatment. Please note this is not the last date of study drug, this is the date the participant returns to site and is discontinued from treatment by the PI.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 14:41:23.233,20260123 08:57:07.033,20260123 15:04:40.640,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Treatment Disposition - Induction,0/0/V,,Treatment Disposition Date,Site from Medical Reviewer,18601315 (18582957),Closed,joetrombello1,23 Jan 2026 15:04:40:793,v.smidkova1,27 Jan 2026 07:05:20:150,joetrombello1,27 Jan 2026 15:59:36:747,,4,0,medical reviewer: Pls revise date to the date when the decision was made to discontinue the subject from treatment; typically this is before the final study f/u visit.,updated   to same date like a V1.7,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260123 15:04:40.793,20260127 07:05:20.150,20260127 15:59:36.747,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,What was the subject's status? (Derived field),Site from Medical Reviewer,18535679,Closed,joetrombello1,20 Jan 2026 13:34:19:747,v.smidkova1,22 Jan 2026 06:51:52:463,joetrombello1,22 Jan 2026 14:42:55:393,,2,0,medical reviewer: Pls complete.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 13:34:19.747,20260122 06:51:52.463,20260122 14:42:55.393,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,What was the subject's primary reason for trial discontinuation/completion?,Site from Medical Reviewer,18582972,Closed,joetrombello1,22 Jan 2026 14:42:54:203,v.smidkova1,23 Jan 2026 08:57:22:883,joetrombello1,23 Jan 2026 15:02:54:800,,1,0,"medical reviewer: Please review and revise response, recalling study conventions that pts. who complete the second f/u visit are considered trial completers. ",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 14:42:54.203,20260123 08:57:22.883,20260123 15:02:54.800,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,19556291,Closed,Ashwini201,17 Mar 2026 11:18:48:580,v.smidkova1,19 Mar 2026 07:46:24:830,shyamaprasad972,23 Mar 2026 06:48:19:867,,2,4,"DM: Please verify and update the data on all blank forms of Screening to end of study, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 11:18:48.580,20260319 07:46:24.830,20260323 06:48:19.867,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,19758999,Closed,Ashwini201,30 Mar 2026 12:36:14:063,v.smidkova1,09 Apr 2026 06:25:27:423,shyamaprasad972,09 Apr 2026 10:37:56:923,,10,0,"DM: Please reactivate the Change in Background Antidepressant and Drug Expiry Information forms and update the data as appropriate, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 12:36:14.063,20260409 06:25:27.423,20260409 10:37:56.923,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16041811,Closed,inayath1,19 Sep 2025 06:44:53:390,v.smidkova1,25 Sep 2025 07:34:24:253,inayath1,27 Sep 2025 14:40:29:317,,6,2,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 06:44:53.390,20250925 07:34:24.253,20250927 14:40:29.317,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,16602838,Closed,Ashwini201,27 Oct 2025 13:05:25:737,v.smidkova1,29 Oct 2025 10:50:44:410,Ashwini201,31 Oct 2025 08:47:47:560,,2,2,"DM: Please verify and update the data on Arizona Sexual Experiences Scale Summary and Educational Level forms, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 13:05:25.737,20251029 10:50:44.410,20251031 08:47:47.560,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,19556305,Closed,Ashwini201,17 Mar 2026 11:19:27:897,v.smidkova1,19 Mar 2026 07:43:30:427,shyamaprasad972,23 Mar 2026 06:49:32:830,,2,4,DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.,form Procedures updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 11:19:27.897,20260319 07:43:30.427,20260323 06:49:32.830,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16801854,Closed,ewajs1,05 Nov 2025 11:49:44:997,v.smidkova1,12 Nov 2025 13:27:33:963,ewajs1,01 Jan 2026 17:27:47:337,,7,50,Is the etiology of diabetes insipidus known? Did the subject had any brain imaging done?,we don't have more information,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 11:49:44.997,20251112 13:27:33.963,20260101 17:27:47.337,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,3,Is the medical history disease/condition or event still ongoing?,DM,18269704,Closed,Juhita@ksha4,31 Dec 2025 12:16:39:817,v.smidkova1,02 Jan 2026 07:54:16:190,Juhita@ksha4,06 Jan 2026 10:39:22:797,,2,4,Medical Review I-941341: Please confirm if MH is still ongoing or else update the end date. Kindly mention the cause of MH term.,still ongoing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251231 12:16:39.817,20260102 07:54:16.190,20260106 10:39:22.797,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,5,What is the verbatim term for the medical history condition/event?,DM,16079999,Closed,Juhita@ksha4,23 Sep 2025 08:40:03:280,r.gregar1,01 Oct 2025 12:25:54:503,Juhita@ksha4,03 Oct 2025 14:56:45:497,,8,2,"Medical Review I-120229: Please provide additional specification on the nature of these disorders, including any more specific diagnoses or symptoms, and comment on I/E criteria.",Anxiety is a part of depression,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250923 08:40:03.280,20251001 12:25:54.503,20251003 14:56:45.497,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,5,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16183942,Closed,inayath1,27 Sep 2025 14:43:16:387,r.gregar1,01 Oct 2025 12:41:53:440,inayath1,02 Oct 2025 04:08:05:850,,4,1,"Eligibility: Given that  anxiety is ongoing since 2017, please confirm that indeed anxiety is not the patient's current primary psychiatric diagnosis per exclusion #12.","No. According to SI, the primary diagnosis is depression, and anxiety is only related to it.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250927 14:43:16.387,20251001 12:41:53.440,20251002 04:08:05.850,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,7,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16041730,Closed,inayath1,19 Sep 2025 06:36:59:627,r.gregar1,01 Oct 2025 12:28:44:680,inayath1,02 Oct 2025 04:08:30:757,,12,1,Eligibility: Please confirm whether hysterectomy was partial or complete. ,HYSTERECTOMY complete,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 06:36:59.627,20251001 12:28:44.680,20251002 04:08:30.757,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,8,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16041723,Closed,inayath1,19 Sep 2025 06:35:26:093,r.gregar1,01 Oct 2025 12:42:54:623,inayath1,02 Oct 2025 04:12:17:627,,12,1,"Eligibility: As per MH log, the subject had Menopause and hysterectomy in 2015 with unknown date and month. Please confirm which event occurred earlier.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250919 06:35:26.093,20251001 12:42:54.623,20251002 04:12:17.627,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,DM,16080113,Closed,Juhita@ksha4,23 Sep 2025 08:45:10:737,r.gregar1,01 Oct 2025 12:31:16:037,Juhita@ksha4,03 Oct 2025 14:55:33:787,,8,2,"Medical Review I-120230: Please provide additional specification on the nature of these disorders, including any more specific diagnoses or symptoms, and comment on I/E criteria.",sleep disorder as part of depression,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250923 08:45:10.737,20251001 12:31:16.037,20251003 14:55:33.787,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,DM,16294174,Closed,Juhita@ksha4,07 Oct 2025 06:17:25:367,v.smidkova1,15 Oct 2025 11:12:13:163,Juhita@ksha4,16 Oct 2025 09:54:31:737,,8,1,"RQ-MR1 I-120230: Please provide any more specific terminology on these disorders, if known.","goes to bed at 10:00 PM, falls asleep at 6:00 AM, sleeps until 9:00 AM, but wakes up twice during sleep, this pattern has been repeated for the last 3 years",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 06:17:25.367,20251015 11:12:13.163,20251016 09:54:31.737,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,DM,18269660,Closed,Juhita@ksha4,31 Dec 2025 12:12:45:423,v.smidkova1,07 Jan 2026 11:04:47:437,Juhita@ksha4,09 Jan 2026 09:16:36:557,,7,2,Medical Review I-941342: Kindly update the specific type of sleep disorder.,interrupted sleep,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251231 12:12:45.423,20260107 11:04:47.437,20260109 09:16:36.557,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,DM,18788083,Closed,Juhita@ksha4,05 Feb 2026 13:25:33:737,v.smidkova1,18 Feb 2026 07:50:50:473,Juhita@ksha4,20 Feb 2026 11:32:03:033,,13,2,"RQ MR1 I-941342: Kindly update the specific type of sleep disorder like narcolepsy, insomnia etc.",insomnia connected with depression - part of depression symptoms,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 13:25:33.737,20260218 07:50:50.473,20260220 11:32:03.033,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,DM,19439291,Closed,Juhita@ksha4,10 Mar 2026 09:34:45:517,v.smidkova1,12 Mar 2026 07:45:25:340,Juhita@ksha4,13 Mar 2026 09:45:33:497,,2,1,"RQ MR2 I-941342: Thank you for the response, please update the term accordingly.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 09:34:45.517,20260312 07:45:25.340,20260313 09:45:33.497,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,General Medical History,0/0/N,12,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,20015854,Closed,MAhmad203,16 Apr 2026 18:04:05:837,v.smidkova1,22 Apr 2026 11:58:28:783,MAhmad203,25 Apr 2026 17:12:37:543,,6,3,"Please specify the sleep disorder.  If it is insomnia, please specify insomnia.  &quot;Sleep Disorder&quot; is too broad of a term.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260416 18:04:05.837,20260422 11:58:28.783,20260425 17:12:37.543,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,16333093,Closed,systemuser,09 Oct 2025 08:40:16:033,systemuser,09 Oct 2025 08:40:23:573,systemuser,09 Oct 2025 08:40:23:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:40:16.033,20251009 08:40:23.573,20251009 08:40:23.577,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,16264120,Closed,systemuser,06 Oct 2025 05:04:31:650,systemuser,06 Oct 2025 05:04:47:250,systemuser,06 Oct 2025 05:04:47:253,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 05:04:31.650,20251006 05:04:47.250,20251006 05:04:47.253,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,16264118,Closed,systemuser,06 Oct 2025 05:03:19:330,systemuser,06 Oct 2025 05:04:31:397,systemuser,06 Oct 2025 05:04:31:400,,0,0,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 05:03:19.330,20251006 05:04:31.397,20251006 05:04:31.400,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,16316665,Closed,systemuser,08 Oct 2025 09:41:48:203,,,systemuser,09 Oct 2025 08:59:00:487,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251008 09:41:48.203,,20251009 08:59:00.487,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,18684101,Closed,Juhita@ksha4,29 Jan 2026 14:48:05:590,v.smidkova1,05 Feb 2026 09:11:12:563,Juhita@ksha4,09 Feb 2026 05:23:05:147,,7,4,Medical Review I-1851752: Please provide an end date to study medication.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 14:48:05.590,20260205 09:11:12.563,20260209 05:23:05.147,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,17060222,Closed,systemuser,18 Nov 2025 09:42:33:387,,,systemuser,21 Nov 2025 11:02:29:397,,,3,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 09:42:33.387,,20251121 11:02:29.397,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,17628935,Closed,systemuser,04 Dec 2025 14:01:07:020,systemuser,04 Dec 2025 14:01:37:697,systemuser,04 Dec 2025 14:01:37:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.020,20251204 14:01:37.697,20251204 14:01:37.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,17628936,Closed,systemuser,04 Dec 2025 14:01:07:030,systemuser,04 Dec 2025 14:01:37:700,systemuser,04 Dec 2025 14:01:37:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.030,20251204 14:01:37.700,20251204 14:01:37.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,17628937,Closed,systemuser,04 Dec 2025 14:01:07:070,systemuser,04 Dec 2025 14:01:37:700,systemuser,04 Dec 2025 14:01:37:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.070,20251204 14:01:37.700,20251204 14:01:37.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,17628938,Closed,systemuser,04 Dec 2025 14:01:07:083,systemuser,04 Dec 2025 14:01:37:700,systemuser,04 Dec 2025 14:01:37:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.083,20251204 14:01:37.700,20251204 14:01:37.700,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,17628939,Closed,systemuser,04 Dec 2025 14:01:07:090,systemuser,04 Dec 2025 14:01:37:700,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.090,20251204 14:01:37.700,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,17628940,Closed,systemuser,04 Dec 2025 14:01:07:100,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.100,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,17628941,Closed,systemuser,04 Dec 2025 14:01:07:110,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.110,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,17628942,Closed,systemuser,04 Dec 2025 14:01:07:120,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.120,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,17628943,Closed,systemuser,04 Dec 2025 14:01:07:127,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.127,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,17628934,Closed,systemuser,04 Dec 2025 14:01:07:010,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.010,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,17628933,Closed,systemuser,04 Dec 2025 14:01:07:000,systemuser,04 Dec 2025 14:01:37:703,systemuser,04 Dec 2025 14:01:37:703,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 14:01:07.000,20251204 14:01:37.703,20251204 14:01:37.703,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17628855,Closed,systemuser,04 Dec 2025 13:59:03:600,systemuser,04 Dec 2025 13:59:11:813,systemuser,04 Dec 2025 13:59:11:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:59:03.600,20251204 13:59:11.813,20251204 13:59:11.817,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,18132844,Closed,systemuser,19 Dec 2025 12:31:19:810,systemuser,19 Dec 2025 12:31:51:830,systemuser,19 Dec 2025 12:31:51:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 12:31:19.810,20251219 12:31:51.830,20251219 12:31:51.833,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18132714,Closed,systemuser,19 Dec 2025 12:27:20:713,v.smidkova1,19 Dec 2025 12:27:50:170,shyamaprasad972,23 Dec 2025 08:04:02:070,,0,4,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 12:27:20.713,20251219 12:27:50.170,20251223 08:04:02.070,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18276519,Closed,systemuser,02 Jan 2026 10:26:15:853,m.deif2,02 Jan 2026 10:27:20:073,Ashwini201,02 Jan 2026 12:03:20:733,,0,0,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 10:26:15.853,20260102 10:27:20.073,20260102 12:03:20.733,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18276518,Closed,systemuser,02 Jan 2026 10:26:15:840,systemuser,02 Jan 2026 10:27:31:313,systemuser,02 Jan 2026 10:27:31:317,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 10:26:15.840,20260102 10:27:31.313,20260102 10:27:31.317,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19556342,Closed,Ashwini201,17 Mar 2026 11:20:46:037,v.smidkova1,19 Mar 2026 07:44:57:020,Ashwini201,25 Mar 2026 08:51:38:553,,2,6,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",updated ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 11:20:46.037,20260319 07:44:57.020,20260325 08:51:38.553,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19690356 (19556342),Closed,Ashwini201,25 Mar 2026 08:51:38:687,v.smidkova1,25 Mar 2026 12:21:49:503,Ashwini201,26 Mar 2026 15:36:45:827,,0,1,RQ-DM1: Thank you for the response. Kindly reactivate the Arizona Sexual Experiences Scale-Female forms and update the data as appropriate.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 08:51:38.687,20260325 12:21:49.503,20260326 15:36:45.827,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,5,Are there any findings?,Auto,18465089,Closed,systemuser,15 Jan 2026 15:24:02:140,systemuser,15 Jan 2026 15:24:24:463,systemuser,15 Jan 2026 15:24:24:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 15:24:02.140,20260115 15:24:24.463,20260115 15:24:24.463,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,18465222,Closed,systemuser,15 Jan 2026 15:33:11:560,systemuser,15 Jan 2026 15:33:24:517,systemuser,15 Jan 2026 15:33:24:517,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 15:33:11.560,20260115 15:33:24.517,20260115 15:33:24.517,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,18464884,Closed,systemuser,15 Jan 2026 15:20:21:040,systemuser,22 Jan 2026 06:48:36:610,systemuser,22 Jan 2026 06:48:36:617,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 15:20:21.040,20260122 06:48:36.610,20260122 06:48:36.617,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 1.7 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,18464885,Closed,systemuser,15 Jan 2026 15:20:21:100,systemuser,22 Jan 2026 06:48:37:883,systemuser,22 Jan 2026 06:48:37:883,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 15:20:21.100,20260122 06:48:37.883,20260122 06:48:37.883,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,16333011,Closed,systemuser,09 Oct 2025 08:38:04:560,systemuser,09 Oct 2025 08:38:17:830,systemuser,09 Oct 2025 08:38:17:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:38:04.560,20251009 08:38:17.830,20251009 08:38:17.833,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,16333009,Closed,systemuser,09 Oct 2025 08:38:04:513,systemuser,09 Oct 2025 08:38:17:847,systemuser,09 Oct 2025 08:38:17:850,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:38:04.513,20251009 08:38:17.847,20251009 08:38:17.850,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,16333010,Closed,systemuser,09 Oct 2025 08:38:04:543,systemuser,09 Oct 2025 08:38:17:850,systemuser,09 Oct 2025 08:38:17:850,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:38:04.543,20251009 08:38:17.850,20251009 08:38:17.850,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,17287976,Closed,Ashwini201,25 Nov 2025 14:32:49:130,m.deif2,27 Nov 2025 09:55:57:327,Ashwini201,28 Nov 2025 09:49:47:277,,2,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:32:49.130,20251127 09:55:57.327,20251128 09:49:47.277,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,16332985,Closed,systemuser,09 Oct 2025 08:37:41:327,systemuser,09 Oct 2025 08:37:50:687,systemuser,09 Oct 2025 08:37:50:687,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:37:41.327,20251009 08:37:50.687,20251009 08:37:50.687,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,16332836,Closed,systemuser,09 Oct 2025 08:28:13:730,systemuser,09 Oct 2025 08:28:22:887,systemuser,09 Oct 2025 08:28:22:887,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:28:13.730,20251009 08:28:22.887,20251009 08:28:22.887,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Sheehan Disability Scale,0/0/N,,On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities?,Auto,16332937,Closed,systemuser,09 Oct 2025 08:34:16:020,systemuser,16 Oct 2025 10:48:36:720,systemuser,16 Oct 2025 10:48:36:723,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:34:16.020,20251016 10:48:36.720,20251016 10:48:36.723,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Sheehan Disability Scale,0/0/N,,"On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work or had other daily responsibilities, your productivity was reduced?",Auto,16332938,Closed,systemuser,09 Oct 2025 08:34:16:033,systemuser,16 Oct 2025 10:48:36:723,systemuser,16 Oct 2025 10:48:36:723,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:34:16.033,20251016 10:48:36.723,20251016 10:48:36.723,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16332726,Closed,systemuser,09 Oct 2025 08:21:34:903,systemuser,09 Oct 2025 08:21:46:433,systemuser,09 Oct 2025 08:21:46:437,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 08:21:34.903,20251009 08:21:46.433,20251009 08:21:46.437,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,16432457,Closed,systemuser,16 Oct 2025 06:57:27:530,systemuser,16 Oct 2025 06:57:56:113,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.530,20251016 06:57:56.113,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,16432458,Closed,systemuser,16 Oct 2025 06:57:27:550,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.550,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,16432459,Closed,systemuser,16 Oct 2025 06:57:27:640,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.640,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,16432460,Closed,systemuser,16 Oct 2025 06:57:27:660,systemuser,16 Oct 2025 06:58:03:370,systemuser,16 Oct 2025 06:58:03:370,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.660,20251016 06:58:03.370,20251016 06:58:03.370,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,16432461,Closed,systemuser,16 Oct 2025 06:57:27:670,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.670,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,16432462,Closed,systemuser,16 Oct 2025 06:57:27:690,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.690,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,16432463,Closed,systemuser,16 Oct 2025 06:57:27:710,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.710,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,16432464,Closed,systemuser,16 Oct 2025 06:57:27:723,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.723,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,16432465,Closed,systemuser,16 Oct 2025 06:57:27:740,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.740,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,16432456,Closed,systemuser,16 Oct 2025 06:57:27:520,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.520,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 5 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,16432455,Closed,systemuser,16 Oct 2025 06:57:27:487,systemuser,16 Oct 2025 06:57:56:117,systemuser,16 Oct 2025 06:57:56:117,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251016 06:57:27.487,20251016 06:57:56.117,20251016 06:57:56.117,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,16990647,Closed,systemuser,13 Nov 2025 14:19:54:903,systemuser,13 Nov 2025 14:20:25:220,systemuser,13 Nov 2025 14:20:25:220,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:19:54.903,20251113 14:20:25.220,20251113 14:20:25.220,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,16990645,Closed,systemuser,13 Nov 2025 14:19:54:850,systemuser,13 Nov 2025 14:20:25:237,systemuser,13 Nov 2025 14:20:25:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:19:54.850,20251113 14:20:25.237,20251113 14:20:25.237,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,16990646,Closed,systemuser,13 Nov 2025 14:19:54:883,systemuser,13 Nov 2025 14:20:25:237,systemuser,13 Nov 2025 14:20:25:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:19:54.883,20251113 14:20:25.237,20251113 14:20:25.237,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.",Auto,16990657,Closed,systemuser,13 Nov 2025 14:20:42:963,systemuser,13 Nov 2025 14:20:56:087,systemuser,13 Nov 2025 14:20:56:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:20:42.963,20251113 14:20:56.087,20251113 14:20:56.090,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.",Auto,16990656,Closed,systemuser,13 Nov 2025 14:20:42:950,systemuser,13 Nov 2025 14:20:56:090,systemuser,13 Nov 2025 14:20:56:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:20:42.950,20251113 14:20:56.090,20251113 14:20:56.090,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your sleep problems?",Auto,16990658,Closed,systemuser,13 Nov 2025 14:20:42:977,systemuser,13 Nov 2025 14:20:56:090,systemuser,13 Nov 2025 14:20:56:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:20:42.977,20251113 14:20:56.090,20251113 14:20:56.090,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,16990655,Closed,systemuser,13 Nov 2025 14:20:42:930,systemuser,13 Nov 2025 14:20:56:090,systemuser,13 Nov 2025 14:20:56:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:20:42.930,20251113 14:20:56.090,20251113 14:20:56.090,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,16990572,Closed,systemuser,13 Nov 2025 14:17:42:247,systemuser,13 Nov 2025 14:18:30:947,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.247,20251113 14:18:30.947,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,16990573,Closed,systemuser,13 Nov 2025 14:17:42:257,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.257,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,16990574,Closed,systemuser,13 Nov 2025 14:17:42:267,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.267,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,16990575,Closed,systemuser,13 Nov 2025 14:17:42:277,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.277,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,16990576,Closed,systemuser,13 Nov 2025 14:17:42:287,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.287,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,16990577,Closed,systemuser,13 Nov 2025 14:17:42:300,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.300,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,16990578,Closed,systemuser,13 Nov 2025 14:17:42:310,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.310,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,16990579,Closed,systemuser,13 Nov 2025 14:17:42:320,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.320,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,16990580,Closed,systemuser,13 Nov 2025 14:17:42:330,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.330,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,16990581,Closed,systemuser,13 Nov 2025 14:17:42:340,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.340,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,16990571,Closed,systemuser,13 Nov 2025 14:17:42:220,systemuser,13 Nov 2025 14:18:30:950,systemuser,13 Nov 2025 14:18:30:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:17:42.220,20251113 14:18:30.950,20251113 14:18:30.950,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16990425,Closed,systemuser,13 Nov 2025 14:14:12:860,systemuser,13 Nov 2025 14:14:33:340,systemuser,13 Nov 2025 14:14:33:343,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 14:14:12.860,20251113 14:14:33.340,20251113 14:14:33.343,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,17060320,Closed,systemuser,18 Nov 2025 09:44:42:667,systemuser,18 Nov 2025 09:45:15:717,systemuser,18 Nov 2025 09:45:15:717,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 09:44:42.667,20251118 09:45:15.717,20251118 09:45:15.717,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 8 Part 1 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,18173474,Closed,Ashwini201,23 Dec 2025 07:15:42:467,v.smidkova1,02 Jan 2026 07:52:05:727,Ashwini201,02 Jan 2026 12:01:18:953,,10,0,"DM: Please verify and update the data on Local Labs for Background Antidepressant Compliance form, else clarify.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:15:42.467,20260102 07:52:05.727,20260102 12:01:18.953,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,17100110,Closed,systemuser,19 Nov 2025 14:18:57:360,systemuser,19 Nov 2025 14:19:05:503,systemuser,19 Nov 2025 14:19:05:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 14:18:57.360,20251119 14:19:05.503,20251119 14:19:05.503,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,17099993,Closed,systemuser,19 Nov 2025 14:15:55:473,m.deif2,21 Nov 2025 10:58:42:247,Ashwini201,24 Nov 2025 06:55:13:287,,2,3,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,value is considered not clinically significant,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 14:15:55.473,20251121 10:58:42.247,20251124 06:55:13.287,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080005,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17099992,Closed,systemuser,19 Nov 2025 14:15:55:410,systemuser,19 Nov 2025 14:16:04:407,systemuser,19 Nov 2025 14:16:04:410,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 14:15:55.410,20251119 14:16:04.407,20251119 14:16:04.410,94,335,335,41,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,2,Start Date,DM,18628793,Closed,Lisa232,27 Jan 2026 08:12:53:523,v.smidkova1,29 Jan 2026 07:33:33:297,Lisa232,30 Jan 2026 10:25:08:393,,2,1,DM: The start date 18 Jan 2025 of the logline#2 is overlapping with the end date 17 Jun  2025 of logline #1. Please verify and update the dates accordingly. ,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260127 08:12:53.523,20260129 07:33:33.297,20260130 10:25:08.393,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,"If No, or if selected medication/therapy is Other - Medication or Therapy",Auto,18434554,Closed,systemuser,14 Jan 2026 09:05:42:857,systemuser,14 Jan 2026 09:14:48:240,systemuser,14 Jan 2026 09:14:48:240,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 09:05:42.857,20260114 09:14:48.240,20260114 09:14:48.240,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,19720069,Closed,systemuser,26 Mar 2026 09:47:36:380,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.380,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,19720070,Closed,systemuser,26 Mar 2026 09:47:36:413,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.413,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,19720071,Closed,systemuser,26 Mar 2026 09:47:36:440,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.440,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,19720072,Closed,systemuser,26 Mar 2026 09:47:36:467,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.467,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,19720073,Closed,systemuser,26 Mar 2026 09:47:36:493,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.493,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,19720074,Closed,systemuser,26 Mar 2026 09:47:36:523,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.523,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,19720075,Closed,systemuser,26 Mar 2026 09:47:36:550,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.550,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,19720076,Closed,systemuser,26 Mar 2026 09:47:36:580,systemuser,26 Mar 2026 09:48:13:340,systemuser,26 Mar 2026 09:48:13:340,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.580,20260326 09:48:13.340,20260326 09:48:13.340,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),PROMIS - Sleep Disturbance,0/0/V,,Was the collection date the same as the visit date?,Auto,19720068,Closed,systemuser,26 Mar 2026 09:47:36:330,systemuser,26 Mar 2026 09:48:13:343,systemuser,26 Mar 2026 09:48:13:343,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:47:36.330,20260326 09:48:13.343,20260326 09:48:13.343,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Follow-up 7-14 Days After (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19719837,Closed,systemuser,26 Mar 2026 09:42:55:403,systemuser,26 Mar 2026 09:43:02:023,systemuser,26 Mar 2026 09:43:02:023,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 09:42:55.403,20260326 09:43:02.023,20260326 09:43:02.023,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260224 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19142894,Closed,systemuser,24 Feb 2026 09:44:53:063,systemuser,24 Feb 2026 11:46:55:913,systemuser,24 Feb 2026 11:46:56:027,,0,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 09:44:53.063,20260224 11:46:55.913,20260224 11:46:56.027,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260416 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19892390,Closed,systemuser,09 Apr 2026 12:58:29:787,systemuser,16 Apr 2026 09:16:55:347,systemuser,16 Apr 2026 09:16:55:613,,7,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 12:58:29.787,20260416 09:16:55.347,20260416 09:16:55.613,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933219,Closed,systemuser,20 May 2026 12:03:36:440,,,systemuser,20 May 2026 12:03:58:537,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:03:36.440,,20260520 12:03:58.537,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,17897373,Closed,systemuser,10 Dec 2025 13:52:25:117,,,systemuser,18 Dec 2025 09:42:43:060,,,8,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:25.117,,20251218 09:42:43.060,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,What was the subject's primary reason for treatment discontinuation/completion?,DM,19632415,Closed,Juhita@ksha4,23 Mar 2026 05:38:05:793,v.smidkova1,25 Mar 2026 12:27:39:827,Juhita@ksha4,25 Mar 2026 15:03:34:967,,2,0,Medical Review I-3093906: Response does not align with expectations when stable response criteria is not met. Please review and revise.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 05:38:05.793,20260325 12:27:39.827,20260325 15:03:34.967,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,Treatment Disposition Date,DM,19541529,Closed,JThoma858,17 Mar 2026 05:51:02:290,v.smidkova1,19 Mar 2026 07:41:17:640,Juhita@ksha4,20 Mar 2026 14:22:51:437,,2,1,Medical Review  I-3062241 : Please complete page.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 05:51:02.290,20260319 07:41:17.640,20260320 14:22:51.437,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,Treatment Disposition Date,DM,19709598,Closed,Juhita@ksha4,26 Mar 2026 06:27:29:697,v.smidkova1,26 Mar 2026 06:58:18:770,Juhita@ksha4,26 Mar 2026 11:47:34:460,,0,0,Medical Review I-3093906: Please revise the date to align with study expectations as the in-clinic visit when decision to discontinue drug occurred.,updated to 10 MAR,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 06:27:29.697,20260326 06:58:18.770,20260326 11:47:34.460,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,What was the subject's primary reason for trial discontinuation/completion?,Auto,19892391,Closed,systemuser,09 Apr 2026 12:58:29:827,systemuser,09 Apr 2026 12:58:41:980,systemuser,09 Apr 2026 12:58:41:983,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 12:58:29.827,20260409 12:58:41.980,20260409 12:58:41.983,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,19814337,Closed,Juhita@ksha4,02 Apr 2026 12:19:34:510,w.naddaf1,09 Apr 2026 12:58:48:627,Juhita@ksha4,10 Apr 2026 07:09:38:597,,7,1,Medical Review I-3115749: Please complete disposition page.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260402 12:19:34.510,20260409 12:58:48.627,20260410 07:09:38.597,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,20426118,Closed,Ashwini201,27 Apr 2026 07:04:23:953,v.smidkova1,29 Apr 2026 11:40:35:983,Ashwini201,04 May 2026 11:08:48:303,,2,5,"DM: Please reactivate the Change in Background Antidepressant and Drug Expiry Information forms and update the data as appropriate, else clarify.",data addition added to all forms,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 07:04:23.953,20260429 11:40:35.983,20260504 11:08:48.303,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Intensity of IdeationMost Severe IdeationLifetime,Auto,16022788,Closed,systemuser,18 Sep 2025 08:58:56:207,,,systemuser,18 Sep 2025 09:00:53:573,,,0,The Intesity of Ideation entered does not match the highest endorsed suicidal ideation above.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:58:56.207,,20250918 09:00:53.573,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Suicidal BehaviorLifetime,Auto,16022790,Closed,systemuser,18 Sep 2025 08:58:56:710,systemuser,30 Sep 2025 13:16:21:187,systemuser,30 Sep 2025 13:16:21:190,,12,0,"Lifetime suicidal behavior is marked ""No"" but at least one of the suicidal behavior items above is marked 'Yes'.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:58:56.710,20250930 13:16:21.187,20250930 13:16:21.190,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16162107,Cancelled,inayath1,26 Sep 2025 05:23:56:397,,,inayath1,29 Sep 2025 12:14:25:977,,,,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250926 05:23:56.397,,20250929 12:14:25.977,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,20133561,Closed,Ashwini201,23 Apr 2026 08:20:31:983,v.smidkova1,24 Apr 2026 07:43:47:547,Ashwini201,29 Apr 2026 08:43:10:060,,1,5,DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 08:20:31.983,20260424 07:43:47.547,20260429 08:43:10.060,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,16021227,Closed,systemuser,18 Sep 2025 08:42:45:930,systemuser,18 Sep 2025 08:44:04:377,systemuser,18 Sep 2025 08:44:04:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:45.930,20250918 08:44:04.377,20250918 08:44:04.377,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,16021228,Closed,systemuser,18 Sep 2025 08:42:45:943,systemuser,18 Sep 2025 08:44:04:380,systemuser,18 Sep 2025 08:44:04:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:45.943,20250918 08:44:04.380,20250918 08:44:04.380,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,16021229,Closed,systemuser,18 Sep 2025 08:42:45:980,systemuser,18 Sep 2025 08:44:04:380,systemuser,18 Sep 2025 08:44:04:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:45.980,20250918 08:44:04.380,20250918 08:44:04.380,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,16021230,Closed,systemuser,18 Sep 2025 08:42:46:003,systemuser,18 Sep 2025 08:44:04:380,systemuser,18 Sep 2025 08:44:04:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.003,20250918 08:44:04.380,20250918 08:44:04.380,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,16021231,Closed,systemuser,18 Sep 2025 08:42:46:027,systemuser,18 Sep 2025 08:44:04:380,systemuser,18 Sep 2025 08:44:04:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.027,20250918 08:44:04.380,20250918 08:44:04.380,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Collection Time,Auto,16021226,Closed,systemuser,18 Sep 2025 08:42:45:913,systemuser,18 Sep 2025 08:44:04:403,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:45.913,20250918 08:44:04.403,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,16021232,Closed,systemuser,18 Sep 2025 08:42:46:053,systemuser,18 Sep 2025 08:44:04:407,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.053,20250918 08:44:04.407,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,16021234,Closed,systemuser,18 Sep 2025 08:42:46:080,systemuser,18 Sep 2025 08:44:04:407,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.080,20250918 08:44:04.407,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,16021233,Closed,systemuser,18 Sep 2025 08:42:46:067,systemuser,18 Sep 2025 08:44:04:407,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.067,20250918 08:44:04.407,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,16021235,Closed,systemuser,18 Sep 2025 08:42:46:090,systemuser,18 Sep 2025 08:44:04:407,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:46.090,20250918 08:44:04.407,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,16021225,Closed,systemuser,18 Sep 2025 08:42:45:890,systemuser,18 Sep 2025 08:44:04:407,systemuser,18 Sep 2025 08:44:04:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:45.890,20250918 08:44:04.407,20250918 08:44:04.407,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,General Medical History,0/0/N,1,Start Date,Site from Medical Reviewer,16802261,Closed,ewajs1,05 Nov 2025 12:12:04:103,v.smidkova1,12 Nov 2025 13:36:42:000,ewajs1,01 Jan 2026 17:30:35:133,,7,50,Did the subject ever consulted cardiologist to clarify the etiology of heart murmur?,yes,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 12:12:04.103,20251112 13:36:42.000,20260101 17:30:35.133,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,General Medical History,0/0/N,1,Start Date,Site from Medical Reviewer,18273226 (16802261),Closed,ewajs1,01 Jan 2026 17:30:35:220,v.smidkova1,07 Jan 2026 08:42:05:600,ewajs1,12 Feb 2026 15:12:26:213,,6,36,If any diagnosis was made by cardiologist please update accordingly or comments what was the cause of the murmur,no more details are available,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260101 17:30:35.220,20260107 08:42:05.600,20260212 15:12:26.213,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,General Medical History,0/0/N,1,Start Date,Site from Medical Reviewer,18914075 (18273226),Closed,ewajs1,12 Feb 2026 15:12:25:970,v.smidkova1,17 Feb 2026 13:37:05:337,ewajs1,22 Apr 2026 09:52:09:017,,5,64,"Does this patient have any cardiac complaints eg shortness of breath on exertion, history of fainting, chest pain, arrhythmias etc.",The patient does not have any of the above issues,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 15:12:25.970,20260217 13:37:05.337,20260422 09:52:09.017,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,16022970,Closed,systemuser,18 Sep 2025 09:07:07:073,systemuser,18 Sep 2025 13:07:57:300,systemuser,18 Sep 2025 13:07:57:303,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 09:07:07.073,20250918 13:07:57.300,20250918 13:07:57.303,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,16796282,Closed,systemuser,05 Nov 2025 09:43:48:413,systemuser,05 Nov 2025 09:44:02:397,systemuser,05 Nov 2025 09:44:02:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251105 09:43:48.413,20251105 09:44:02.397,20251105 09:44:02.397,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16021220,Closed,systemuser,18 Sep 2025 08:42:15:720,systemuser,18 Sep 2025 13:08:16:800,systemuser,18 Sep 2025 13:08:16:800,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250918 08:42:15.720,20250918 13:08:16.800,20250918 13:08:16.800,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,16561680,Closed,systemuser,24 Oct 2025 08:56:32:450,systemuser,24 Oct 2025 08:56:44:513,systemuser,24 Oct 2025 08:56:44:517,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251024 08:56:32.450,20251024 08:56:44.513,20251024 08:56:44.517,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,16651534,Closed,systemuser,29 Oct 2025 09:21:34:110,,,systemuser,07 Nov 2025 11:07:14:720,,,9,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:21:34.110,,20251107 11:07:14.720,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,SM,19153260,Closed,Mamaking4,24 Feb 2026 13:48:10:703,v.smidkova1,26 Feb 2026 08:40:25:790,Mamaking4,25 Mar 2026 11:31:24:263,,2,27,"Please correct the end date according the source document (05JAN2026) please check again. PLease, create a new logline with start and stop date of IMP 07-12-Jan-2026",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 13:48:10.703,20260226 08:40:25.790,20260325 11:31:24.263,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,17897372,Closed,systemuser,10 Dec 2025 13:52:25:097,,,systemuser,11 Dec 2025 07:38:08:517,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:25.097,,20251211 07:38:08.517,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,18409649,Closed,systemuser,13 Jan 2026 09:15:31:533,,,systemuser,15 Jan 2026 09:51:48:663,,,2,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 09:15:31.533,,20260115 09:51:48.663,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18238435,Closed,systemuser,29 Dec 2025 13:21:06:857,systemuser,29 Dec 2025 13:21:19:673,systemuser,29 Dec 2025 13:21:19:673,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 13:21:06.857,20251229 13:21:19.673,20251229 13:21:19.673,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,1. How strong is your sex drive?,Auto,18433243,Closed,systemuser,14 Jan 2026 08:00:07:683,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.683,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,2. How easily are you sexually aroused (turned on)?,Auto,18433244,Closed,systemuser,14 Jan 2026 08:00:07:690,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.690,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,3. Can you easily get and keep an erection?,Auto,18433245,Closed,systemuser,14 Jan 2026 08:00:07:700,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.700,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,4. How easily can you reach an orgasm?,Auto,18433246,Closed,systemuser,14 Jan 2026 08:00:07:707,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.707,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,5. Are your orgasms satisfying?,Auto,18433247,Closed,systemuser,14 Jan 2026 08:00:07:713,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.713,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Arizona Sexual Experiences Scale-Male,0/0/N,,Was the collection date the same as the visit date?,Auto,18433242,Closed,systemuser,14 Jan 2026 08:00:07:657,systemuser,14 Jan 2026 08:00:38:287,systemuser,14 Jan 2026 08:00:38:287,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:00:07.657,20260114 08:00:38.287,20260114 08:00:38.287,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,18433224,Closed,systemuser,14 Jan 2026 07:59:10:453,systemuser,14 Jan 2026 07:59:44:553,systemuser,14 Jan 2026 07:59:44:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.453,20260114 07:59:44.553,20260114 07:59:44.557,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,18433225,Closed,systemuser,14 Jan 2026 07:59:10:460,systemuser,14 Jan 2026 07:59:44:557,systemuser,14 Jan 2026 07:59:44:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.460,20260114 07:59:44.557,20260114 07:59:44.557,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,18433226,Closed,systemuser,14 Jan 2026 07:59:10:707,systemuser,14 Jan 2026 07:59:44:557,systemuser,14 Jan 2026 07:59:44:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.707,20260114 07:59:44.557,20260114 07:59:44.557,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,18433227,Closed,systemuser,14 Jan 2026 07:59:10:717,systemuser,14 Jan 2026 07:59:44:557,systemuser,14 Jan 2026 07:59:44:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.717,20260114 07:59:44.557,20260114 07:59:44.557,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,18433228,Closed,systemuser,14 Jan 2026 07:59:10:723,systemuser,14 Jan 2026 07:59:44:557,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.723,20260114 07:59:44.557,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,18433229,Closed,systemuser,14 Jan 2026 07:59:10:730,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.730,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,18433230,Closed,systemuser,14 Jan 2026 07:59:10:747,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.747,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,18433231,Closed,systemuser,14 Jan 2026 07:59:10:760,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.760,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,18433232,Closed,systemuser,14 Jan 2026 07:59:10:763,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.763,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,18433223,Closed,systemuser,14 Jan 2026 07:59:10:447,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.447,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,18433222,Closed,systemuser,14 Jan 2026 07:59:10:430,systemuser,14 Jan 2026 07:59:44:560,systemuser,14 Jan 2026 07:59:44:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:59:10.430,20260114 07:59:44.560,20260114 07:59:44.560,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Mobility,Auto,18433250,Closed,systemuser,14 Jan 2026 08:01:01:913,systemuser,14 Jan 2026 08:02:06:357,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.913,20260114 08:02:06.357,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Self-Care,Auto,18433251,Closed,systemuser,14 Jan 2026 08:01:01:920,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.920,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Usual Activities,Auto,18433252,Closed,systemuser,14 Jan 2026 08:01:01:930,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.930,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Pain/Discomfort,Auto,18433253,Closed,systemuser,14 Jan 2026 08:01:01:940,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.940,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Anxiety/Depression,Auto,18433254,Closed,systemuser,14 Jan 2026 08:01:01:950,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.950,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Your health today,Auto,18433255,Closed,systemuser,14 Jan 2026 08:01:01:957,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.957,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),EQ-5D-5L,0/0/N,,Was the collection date the same as the visit date?,Auto,18433249,Closed,systemuser,14 Jan 2026 08:01:01:900,systemuser,14 Jan 2026 08:02:06:367,systemuser,14 Jan 2026 08:02:06:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:01:01.900,20260114 08:02:06.367,20260114 08:02:06.367,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,18434125,Closed,systemuser,14 Jan 2026 08:52:01:030,systemuser,14 Jan 2026 08:52:10:260,systemuser,14 Jan 2026 08:52:10:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:52:01.030,20260114 08:52:10.260,20260114 08:52:10.270,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18433144,Closed,systemuser,14 Jan 2026 07:53:37:267,systemuser,14 Jan 2026 07:53:44:597,systemuser,14 Jan 2026 07:53:44:597,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:53:37.267,20260114 07:53:44.597,20260114 07:53:44.597,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the questionnaire completed?,Auto,18433361,Closed,systemuser,14 Jan 2026 08:07:24:980,systemuser,27 Jan 2026 06:59:27:747,systemuser,27 Jan 2026 06:59:27:747,,13,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 08:07:24.980,20260127 06:59:27.747,20260127 06:59:27.747,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18433125,Closed,systemuser,14 Jan 2026 07:52:36:123,systemuser,14 Jan 2026 07:53:20:807,systemuser,14 Jan 2026 07:53:20:813,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.123,20260114 07:53:20.807,20260114 07:53:20.813,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Pulse,Auto,18433123,Closed,systemuser,14 Jan 2026 07:52:36:110,systemuser,14 Jan 2026 07:53:20:833,systemuser,14 Jan 2026 07:53:20:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.110,20260114 07:53:20.833,20260114 07:53:20.833,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18433124,Closed,systemuser,14 Jan 2026 07:52:36:117,systemuser,14 Jan 2026 07:53:20:840,systemuser,14 Jan 2026 07:53:20:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.117,20260114 07:53:20.840,20260114 07:53:20.840,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,18433120,Closed,systemuser,14 Jan 2026 07:52:36:050,systemuser,14 Jan 2026 07:53:20:840,systemuser,14 Jan 2026 07:53:20:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.050,20260114 07:53:20.840,20260114 07:53:20.840,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature,Auto,18433122,Closed,systemuser,14 Jan 2026 07:52:36:100,systemuser,14 Jan 2026 07:53:20:840,systemuser,14 Jan 2026 07:53:20:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.100,20260114 07:53:20.840,20260114 07:53:20.843,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Weight,Auto,18433121,Closed,systemuser,14 Jan 2026 07:52:36:080,systemuser,14 Jan 2026 07:53:20:843,systemuser,14 Jan 2026 07:53:20:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 07:52:36.080,20260114 07:53:20.843,20260114 07:53:20.843,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.2 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,18904796,Closed,systemuser,12 Feb 2026 10:05:54:520,systemuser,12 Feb 2026 10:06:07:190,systemuser,12 Feb 2026 10:06:07:197,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 10:05:54.520,20260212 10:06:07.190,20260212 10:06:07.197,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.2 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,18904794,Closed,systemuser,12 Feb 2026 10:05:54:500,systemuser,12 Feb 2026 10:06:07:227,systemuser,12 Feb 2026 10:06:07:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 10:05:54.500,20260212 10:06:07.227,20260212 10:06:07.227,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.2 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,18904795,Closed,systemuser,12 Feb 2026 10:05:54:510,systemuser,12 Feb 2026 10:06:07:227,systemuser,12 Feb 2026 10:06:07:227,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 10:05:54.510,20260212 10:06:07.227,20260212 10:06:07.227,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18904893,Closed,systemuser,12 Feb 2026 10:11:36:067,systemuser,12 Feb 2026 10:11:45:923,systemuser,12 Feb 2026 10:11:45:923,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 10:11:36.067,20260212 10:11:45.923,20260212 10:11:45.923,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,19142898,Closed,systemuser,24 Feb 2026 09:45:07:050,systemuser,24 Feb 2026 09:45:33:020,systemuser,24 Feb 2026 09:45:33:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 09:45:07.050,20260224 09:45:33.020,20260224 09:45:33.020,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,19142896,Closed,systemuser,24 Feb 2026 09:45:07:030,systemuser,24 Feb 2026 09:45:33:037,systemuser,24 Feb 2026 09:45:33:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 09:45:07.030,20260224 09:45:33.037,20260224 09:45:33.037,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.3 Stabilization (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,19142897,Closed,systemuser,24 Feb 2026 09:45:07:043,systemuser,24 Feb 2026 09:45:33:037,systemuser,24 Feb 2026 09:45:33:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 09:45:07.043,20260224 09:45:33.037,20260224 09:45:33.037,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.3 Stabilization (1),Date of Visit,0/0/N,,Type of Contact,Auto,19142893,Closed,systemuser,24 Feb 2026 09:44:53:040,systemuser,24 Feb 2026 09:44:58:887,systemuser,24 Feb 2026 09:44:58:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 09:44:53.040,20260224 09:44:58.887,20260224 09:44:58.890,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19175018,Closed,systemuser,25 Feb 2026 13:04:39:447,systemuser,25 Feb 2026 13:07:14:487,systemuser,25 Feb 2026 13:07:14:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260225 13:04:39.447,20260225 13:07:14.487,20260225 13:07:14.490,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Date of Visit,0/0/N,,Type of Contact,Auto,19438280,Closed,systemuser,10 Mar 2026 08:51:15:327,systemuser,10 Mar 2026 08:51:20:867,systemuser,10 Mar 2026 08:51:20:870,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:15.327,20260310 08:51:20.867,20260310 08:51:20.870,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Local Labs for Background Antidepressant Compliance,0/0/N,,Were local labs collected at this visit to assess compliance with background antidepressant medication?,Auto,19440677,Closed,systemuser,10 Mar 2026 10:41:33:037,systemuser,10 Mar 2026 10:41:37:010,systemuser,10 Mar 2026 10:41:37:010,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 10:41:33.037,20260310 10:41:37.010,20260310 10:41:37.010,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Neurologic Examination,0/0/N,5,Are there any findings?,Auto,19483385,Closed,systemuser,12 Mar 2026 10:23:16:240,systemuser,12 Mar 2026 10:23:29:770,systemuser,12 Mar 2026 10:23:29:770,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260312 10:23:16.240,20260312 10:23:29.770,20260312 10:23:29.770,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/P,,Total score,SM,19698441,Closed,Mamaking4,25 Mar 2026 13:37:13:207,v.smidkova1,26 Mar 2026 06:56:55:993,kminarov1,22 Apr 2026 09:09:11:610,,1,27,correct the total score according to source.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 13:37:13.207,20260326 06:56:55.993,20260422 09:09:11.610,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19483317,Closed,systemuser,12 Mar 2026 10:20:42:380,systemuser,12 Mar 2026 10:20:55:567,systemuser,12 Mar 2026 10:20:55:567,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260312 10:20:42.380,20260312 10:20:55.567,20260312 10:20:55.567,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,19438297,Closed,systemuser,10 Mar 2026 08:51:32:600,systemuser,10 Mar 2026 08:53:44:483,systemuser,10 Mar 2026 08:53:44:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.600,20260310 08:53:44.483,20260310 08:53:44.483,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Rater's Initials,Auto,19438286,Closed,systemuser,10 Mar 2026 08:51:32:517,systemuser,10 Mar 2026 08:53:44:107,systemuser,10 Mar 2026 08:53:44:107,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.517,20260310 08:53:44.107,20260310 08:53:44.107,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,19438285,Closed,systemuser,10 Mar 2026 08:51:32:500,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.500,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,19438287,Closed,systemuser,10 Mar 2026 08:51:32:530,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.530,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,19438288,Closed,systemuser,10 Mar 2026 08:51:32:537,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.537,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,19438289,Closed,systemuser,10 Mar 2026 08:51:32:547,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.547,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,19438290,Closed,systemuser,10 Mar 2026 08:51:32:553,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.553,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,19438291,Closed,systemuser,10 Mar 2026 08:51:32:560,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.560,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,19438292,Closed,systemuser,10 Mar 2026 08:51:32:567,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.567,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,19438293,Closed,systemuser,10 Mar 2026 08:51:32:573,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.573,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,19438294,Closed,systemuser,10 Mar 2026 08:51:32:580,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.580,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,19438295,Closed,systemuser,10 Mar 2026 08:51:32:587,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.587,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 2.4 Stabilization,Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,19438296,Closed,systemuser,10 Mar 2026 08:51:32:593,systemuser,10 Mar 2026 08:53:44:090,systemuser,10 Mar 2026 08:53:44:090,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 08:51:32.593,20260310 08:53:44.090,20260310 08:53:44.090,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,16651329,Closed,systemuser,29 Oct 2025 09:17:26:257,systemuser,29 Oct 2025 09:18:07:133,systemuser,29 Oct 2025 09:18:07:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.257,20251029 09:18:07.133,20251029 09:18:07.137,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,16651330,Closed,systemuser,29 Oct 2025 09:17:26:270,systemuser,29 Oct 2025 09:18:07:137,systemuser,29 Oct 2025 09:18:07:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.270,20251029 09:18:07.137,20251029 09:18:07.137,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,16651331,Closed,systemuser,29 Oct 2025 09:17:26:280,systemuser,29 Oct 2025 09:18:07:137,systemuser,29 Oct 2025 09:18:07:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.280,20251029 09:18:07.137,20251029 09:18:07.137,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,16651332,Closed,systemuser,29 Oct 2025 09:17:26:290,systemuser,29 Oct 2025 09:18:07:137,systemuser,29 Oct 2025 09:18:07:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.290,20251029 09:18:07.137,20251029 09:18:07.137,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,16651333,Closed,systemuser,29 Oct 2025 09:17:26:300,systemuser,29 Oct 2025 09:18:07:137,systemuser,29 Oct 2025 09:18:07:137,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.300,20251029 09:18:07.137,20251029 09:18:07.137,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,16651334,Closed,systemuser,29 Oct 2025 09:17:26:310,systemuser,29 Oct 2025 09:18:07:137,systemuser,29 Oct 2025 09:18:07:140,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.310,20251029 09:18:07.137,20251029 09:18:07.140,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,16651335,Closed,systemuser,29 Oct 2025 09:17:26:320,systemuser,29 Oct 2025 09:18:07:140,systemuser,29 Oct 2025 09:18:07:140,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.320,20251029 09:18:07.140,20251029 09:18:07.140,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,16651328,Closed,systemuser,29 Oct 2025 09:17:26:230,systemuser,29 Oct 2025 09:18:07:140,systemuser,29 Oct 2025 09:18:07:140,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251029 09:17:26.230,20251029 09:18:07.140,20251029 09:18:07.140,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16988879,Closed,systemuser,13 Nov 2025 13:06:25:720,systemuser,13 Nov 2025 13:06:59:443,systemuser,13 Nov 2025 13:06:59:447,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251113 13:06:25.720,20251113 13:06:59.443,20251113 13:06:59.447,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17414378,Closed,systemuser,28 Nov 2025 09:50:13:427,systemuser,28 Nov 2025 09:50:37:240,systemuser,28 Nov 2025 09:50:37:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251128 09:50:13.427,20251128 09:50:37.240,20251128 09:50:37.243,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,17897745,Closed,systemuser,10 Dec 2025 14:00:12:707,systemuser,10 Dec 2025 14:01:12:043,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:12.707,20251210 14:01:12.043,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,17897746,Closed,systemuser,10 Dec 2025 14:00:12:713,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:12.713,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,17897747,Closed,systemuser,10 Dec 2025 14:00:12:757,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:12.757,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,17897748,Closed,systemuser,10 Dec 2025 14:00:13:167,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.167,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,17897749,Closed,systemuser,10 Dec 2025 14:00:13:190,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.190,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,17897750,Closed,systemuser,10 Dec 2025 14:00:13:197,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.197,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,17897751,Closed,systemuser,10 Dec 2025 14:00:13:207,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.207,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,17897752,Closed,systemuser,10 Dec 2025 14:00:13:217,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.217,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,17897753,Closed,systemuser,10 Dec 2025 14:00:13:220,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:13.220,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,17897744,Closed,systemuser,10 Dec 2025 14:00:12:697,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:12.697,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,17897743,Closed,systemuser,10 Dec 2025 14:00:12:677,systemuser,10 Dec 2025 14:01:12:050,systemuser,10 Dec 2025 14:01:12:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 14:00:12.677,20251210 14:01:12.050,20251210 14:01:12.050,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,17897604,Closed,systemuser,10 Dec 2025 13:57:50:063,systemuser,10 Dec 2025 13:58:46:027,systemuser,10 Dec 2025 13:58:46:030,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.063,20251210 13:58:46.027,20251210 13:58:46.030,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,17897605,Closed,systemuser,10 Dec 2025 13:57:50:070,systemuser,10 Dec 2025 13:58:46:030,systemuser,10 Dec 2025 13:58:46:030,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.070,20251210 13:58:46.030,20251210 13:58:46.030,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,17897606,Closed,systemuser,10 Dec 2025 13:57:50:073,systemuser,10 Dec 2025 13:58:46:030,systemuser,10 Dec 2025 13:58:46:030,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.073,20251210 13:58:46.030,20251210 13:58:46.030,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,17897607,Closed,systemuser,10 Dec 2025 13:57:50:080,systemuser,10 Dec 2025 13:58:46:030,systemuser,10 Dec 2025 13:58:46:030,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.080,20251210 13:58:46.030,20251210 13:58:46.030,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,17897608,Closed,systemuser,10 Dec 2025 13:57:50:090,systemuser,10 Dec 2025 13:58:46:030,systemuser,10 Dec 2025 13:58:46:030,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.090,20251210 13:58:46.030,20251210 13:58:46.030,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,17897603,Closed,systemuser,10 Dec 2025 13:57:50:053,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.053,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,17897609,Closed,systemuser,10 Dec 2025 13:57:50:093,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.093,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,17897611,Closed,systemuser,10 Dec 2025 13:57:50:107,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.107,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,17897610,Closed,systemuser,10 Dec 2025 13:57:50:100,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.100,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,17897612,Closed,systemuser,10 Dec 2025 13:57:50:113,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.113,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,17897602,Closed,systemuser,10 Dec 2025 13:57:50:040,systemuser,10 Dec 2025 13:58:46:070,systemuser,10 Dec 2025 13:58:46:070,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:50.040,20251210 13:58:46.070,20251210 13:58:46.070,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17897601,Closed,systemuser,10 Dec 2025 13:57:35:640,systemuser,10 Dec 2025 13:57:43:083,systemuser,10 Dec 2025 13:57:43:087,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:57:35.640,20251210 13:57:43.083,20251210 13:57:43.087,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,17897381,Closed,systemuser,10 Dec 2025 13:52:32:497,systemuser,10 Dec 2025 13:53:05:163,systemuser,10 Dec 2025 13:53:05:163,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.497,20251210 13:53:05.163,20251210 13:53:05.163,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,17897379,Closed,systemuser,10 Dec 2025 13:52:32:480,systemuser,10 Dec 2025 13:53:05:170,systemuser,10 Dec 2025 13:53:05:170,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.480,20251210 13:53:05.170,20251210 13:53:05.170,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,17897380,Closed,systemuser,10 Dec 2025 13:52:32:490,systemuser,10 Dec 2025 13:53:05:177,systemuser,10 Dec 2025 13:53:05:177,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.490,20251210 13:53:05.177,20251210 13:53:05.177,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,17897376,Closed,systemuser,10 Dec 2025 13:52:32:450,systemuser,10 Dec 2025 13:53:05:177,systemuser,10 Dec 2025 13:53:05:177,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.450,20251210 13:53:05.177,20251210 13:53:05.177,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,17897378,Closed,systemuser,10 Dec 2025 13:52:32:470,systemuser,10 Dec 2025 13:53:05:177,systemuser,10 Dec 2025 13:53:05:177,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.470,20251210 13:53:05.177,20251210 13:53:05.177,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080006,Completed,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Weight,Auto,17897377,Closed,systemuser,10 Dec 2025 13:52:32:460,systemuser,10 Dec 2025 13:53:05:177,systemuser,10 Dec 2025 13:53:05:177,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251210 13:52:32.460,20251210 13:53:05.177,20251210 13:53:05.177,94,335,335,46,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,End Date,Auto,17992370,Closed,systemuser,15 Dec 2025 12:46:17:933,systemuser,15 Dec 2025 12:50:11:297,systemuser,15 Dec 2025 12:50:11:310,,0,0,"'Ongoing' is Yes, yet an 'End Date' is provided. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 12:46:17.933,20251215 12:50:11.297,20251215 12:50:11.310,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,7,"If No, or if selected medication/therapy is Other - Medication or Therapy",Auto,18024761,Closed,systemuser,16 Dec 2025 13:59:53:927,systemuser,16 Dec 2025 14:01:02:047,systemuser,16 Dec 2025 14:01:02:050,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251216 13:59:53.927,20251216 14:01:02.047,20251216 14:01:02.050,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,7,Derived Medication or Therapy for coding purposes(derived field),DM,18328016,Closed,CoderImport,07 Jan 2026 09:40:47:507,v.smidkova1,08 Jan 2026 06:48:25:290,systemuser,08 Jan 2026 06:48:25:440,,1,0,"CODING: This trade name ""Atarax"" can be referred with additional active ingredients in the standard coding dictionary. Please add a complete list of active ingredient(s) in parentheses  and make the change to the reported medication field. Examples, ""ATARAX [ALPRAZOLAM]"", ""ATARAX [HYDROXYZINE]"" or others.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 09:40:47.507,20260108 06:48:25.290,20260108 06:48:25.440,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,10,End Date,Site from Medical Reviewer,18240677,Closed,kavya@1510,29 Dec 2025 15:18:57:617,r.gregar1,05 Jan 2026 12:22:17:440,kavya@1510,06 Jan 2026 02:57:57:573,,7,1,"Eligibility: Please note, subject is on Non SSRI/SNRI antidepressant- Trazadone which is not allowed at least 7 days prior to Day 1 until the Follow-up visit. Kindly comment if the drug can be safely tapered off as per exclusion #29 and mention the proposed end date.",data updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 15:18:57.617,20260105 12:22:17.440,20260106 02:57:57.573,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,10,End Date,Auto,18294295,Closed,systemuser,05 Jan 2026 12:21:44:933,systemuser,05 Jan 2026 12:22:01:187,systemuser,05 Jan 2026 12:22:01:200,,0,0,"'Ongoing' is Yes, yet an 'End Date' is provided. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260105 12:21:44.933,20260105 12:22:01.187,20260105 12:22:01.200,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20933227,Closed,systemuser,20 May 2026 12:04:28:487,,,systemuser,20 May 2026 12:04:46:567,,,0,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 12:04:28.487,,20260520 12:04:46.567,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19317587,Closed,systemuser,05 Mar 2026 10:45:58:043,,,systemuser,05 Mar 2026 11:05:07:297,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:45:58.043,,20260305 11:05:07.297,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Arizona Sexual Experiences Scale Summary,0/0/N,,Which version of the Arizona Sexual Experiences Scale will be used?,DM,20671579,Closed,shyamaprasad972,07 May 2026 15:05:45:843,v.smidkova1,12 May 2026 06:16:23:947,SanchariDutta@025,12 May 2026 15:10:08:823,,5,0,"DM: Please clarify use of “not done”, recalling the guidance to select ‘not done’ only if patient declined the scale (Please document in comment if applicable). Additionally, please clarify if the scale was completed by the patient at DB Day 1 or later visits and if so, revise response so that the correct version of the scale will populate and its data can be entered. ",the data is corrected and all questionnaires are completed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260507 15:05:45.843,20260512 06:16:23.947,20260512 15:10:08.823,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Site from Medical Reviewer,18240420,Closed,kavya@1510,29 Dec 2025 15:07:08:023,v.smidkova1,02 Jan 2026 08:01:09:970,Rajani_S_N1,02 Jan 2026 09:39:59:150,,4,0,Eligibility: Kindly update the AE page with appropriate details.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 15:07:08.023,20260102 08:01:09.970,20260102 09:39:59.150,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,17990889,Closed,systemuser,15 Dec 2025 11:55:20:443,systemuser,22 Dec 2025 09:38:17:787,systemuser,22 Dec 2025 09:38:17:787,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.443,20251222 09:38:17.787,20251222 09:38:17.787,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,17990892,Closed,systemuser,15 Dec 2025 11:55:20:453,systemuser,22 Dec 2025 09:38:17:787,systemuser,22 Dec 2025 09:38:17:787,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.453,20251222 09:38:17.787,20251222 09:38:17.787,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,17990894,Closed,systemuser,15 Dec 2025 11:55:20:460,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.460,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,17990896,Closed,systemuser,15 Dec 2025 11:55:20:467,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.467,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,17990898,Closed,systemuser,15 Dec 2025 11:55:20:473,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.473,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Was the sample collected?,Auto,18085897,Closed,systemuser,18 Dec 2025 09:43:30:417,systemuser,18 Dec 2025 09:43:46:723,systemuser,18 Dec 2025 09:43:46:737,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251218 09:43:30.417,20251218 09:43:46.723,20251218 09:43:46.737,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,17990900,Closed,systemuser,15 Dec 2025 11:55:20:480,systemuser,22 Dec 2025 09:38:25:310,systemuser,22 Dec 2025 09:38:25:313,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.480,20251222 09:38:25.310,20251222 09:38:25.313,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,17990904,Closed,systemuser,15 Dec 2025 11:55:20:493,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.493,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,17990902,Closed,systemuser,15 Dec 2025 11:55:20:487,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.487,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,17990906,Closed,systemuser,15 Dec 2025 11:55:20:500,systemuser,22 Dec 2025 09:38:17:790,systemuser,22 Dec 2025 09:38:17:790,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251215 11:55:20.500,20251222 09:38:17.790,20251222 09:38:17.790,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,"MGH ATRQ, Non-Geriatric, Section I and II",0/0/N,2,Taken during THIS current episode of depression,Site from Medical Reviewer,18239517,Closed,joetrombello1,29 Dec 2025 14:18:32:233,r.gregar1,05 Jan 2026 12:23:49:783,joetrombello1,05 Jan 2026 14:03:17:627,,7,0,"medical reviewer: Kindly recall that per study conventions, only medications taken in the current MDE should be listed on the ATRQ in source and EDC. Please review and revise as necessary and integrate with feedback from MGH-CTNI. ",data updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251229 14:18:32.233,20260105 12:23:49.783,20260105 14:03:17.627,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 1,Neurologic Examination,0/0/N,1,Were the findings/diagnosis considered a Medical History Term?,Auto,18594183,Closed,systemuser,23 Jan 2026 10:03:16:650,systemuser,23 Jan 2026 10:03:50:653,systemuser,23 Jan 2026 10:03:50:657,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260123 10:03:16.650,20260123 10:03:50.653,20260123 10:03:50.657,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,18293849,Closed,systemuser,05 Jan 2026 11:48:17:417,systemuser,05 Jan 2026 11:48:30:840,systemuser,05 Jan 2026 11:48:30:843,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260105 11:48:17.417,20260105 11:48:30.840,20260105 11:48:30.843,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,18553969,Closed,systemuser,21 Jan 2026 10:40:17:463,,,systemuser,22 Jan 2026 06:55:54:683,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260121 10:40:17.463,,20260122 06:55:54.683,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,19317586,Closed,systemuser,05 Mar 2026 10:45:57:997,,,systemuser,05 Mar 2026 11:04:29:603,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:45:57.997,,20260305 11:04:29.603,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,Start Date,Auto,20475197,Closed,systemuser,29 Apr 2026 09:52:48:823,,,systemuser,30 Apr 2026 06:54:18:200,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260429 09:52:48.823,,20260430 06:54:18.200,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.4 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,Severity of illness,Auto,19577538,Closed,systemuser,18 Mar 2026 09:38:07:800,systemuser,18 Mar 2026 09:38:18:383,systemuser,18 Mar 2026 09:38:18:387,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260318 09:38:07.800,20260318 09:38:18.383,20260318 09:38:18.387,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.4 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,19577536,Closed,systemuser,18 Mar 2026 09:38:07:777,systemuser,18 Mar 2026 09:38:18:403,systemuser,18 Mar 2026 09:38:18:403,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260318 09:38:07.777,20260318 09:38:18.403,20260318 09:38:18.403,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.4 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,19577537,Closed,systemuser,18 Mar 2026 09:38:07:790,systemuser,18 Mar 2026 09:38:18:403,systemuser,18 Mar 2026 09:38:18:403,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260318 09:38:07.790,20260318 09:38:18.403,20260318 09:38:18.403,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Behavior,Auto,19577615,Closed,systemuser,18 Mar 2026 09:39:13:510,systemuser,18 Mar 2026 09:39:19:303,systemuser,18 Mar 2026 09:39:19:310,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260318 09:39:13.510,20260318 09:39:19.303,20260318 09:39:19.310,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19600157,Closed,systemuser,19 Mar 2026 11:32:20:623,systemuser,19 Mar 2026 11:32:29:817,systemuser,19 Mar 2026 11:32:29:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260319 11:32:20.623,20260319 11:32:29.817,20260319 11:32:29.817,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,19892489,Closed,systemuser,09 Apr 2026 13:01:53:407,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.407,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"2. Feeling down, depressed, or hopeless.",Auto,19892490,Closed,systemuser,09 Apr 2026 13:01:53:417,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.417,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,19892491,Closed,systemuser,09 Apr 2026 13:01:53:430,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.430,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,4. Feeling tired or having little energy.,Auto,19892492,Closed,systemuser,09 Apr 2026 13:01:53:437,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.437,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,5. Poor appetite or overeating.,Auto,19892493,Closed,systemuser,09 Apr 2026 13:01:53:443,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.443,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,19892494,Closed,systemuser,09 Apr 2026 13:01:53:457,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.457,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,19892495,Closed,systemuser,09 Apr 2026 13:01:53:460,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.460,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,19892496,Closed,systemuser,09 Apr 2026 13:01:53:470,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.470,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,19892497,Closed,systemuser,09 Apr 2026 13:01:53:477,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.477,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,19892498,Closed,systemuser,09 Apr 2026 13:01:53:487,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.487,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.5 Induction (1),Patient Health Questionnaire - 9 Item,0/0/N,,Was the collection date the same as the visit date?,Auto,19892488,Closed,systemuser,09 Apr 2026 13:01:53:380,systemuser,09 Apr 2026 13:02:38:357,systemuser,09 Apr 2026 13:02:38:357,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 13:01:53.380,20260409 13:02:38.357,20260409 13:02:38.357,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.6 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20004484,Closed,systemuser,16 Apr 2026 12:30:39:050,systemuser,16 Apr 2026 12:30:49:827,systemuser,16 Apr 2026 12:30:49:830,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260416 12:30:39.050,20260416 12:30:49.827,20260416 12:30:49.830,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,Severity of illness,Auto,20475205,Closed,systemuser,29 Apr 2026 09:53:40:170,systemuser,29 Apr 2026 09:53:54:467,systemuser,29 Apr 2026 09:53:54:473,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260429 09:53:40.170,20260429 09:53:54.467,20260429 09:53:54.473,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,20475203,Closed,systemuser,29 Apr 2026 09:53:40:073,systemuser,29 Apr 2026 09:53:54:507,systemuser,29 Apr 2026 09:53:54:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260429 09:53:40.073,20260429 09:53:54.507,20260429 09:53:54.507,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Clinical Global Impression - S (Depression),0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,20475204,Closed,systemuser,29 Apr 2026 09:53:40:147,systemuser,29 Apr 2026 09:53:54:507,systemuser,29 Apr 2026 09:53:54:507,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260429 09:53:40.147,20260429 09:53:54.507,20260429 09:53:54.507,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,,Was the neurological examination performed?,Auto,20510963,Closed,systemuser,30 Apr 2026 08:56:49:310,systemuser,30 Apr 2026 08:57:21:650,systemuser,30 Apr 2026 08:57:21:653,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:56:49.310,20260430 08:57:21.650,20260430 08:57:21.653,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,1,Are there any findings?,Auto,20510968,Closed,systemuser,30 Apr 2026 08:57:21:723,systemuser,30 Apr 2026 08:57:36:547,systemuser,30 Apr 2026 08:57:36:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:57:21.723,20260430 08:57:36.547,20260430 08:57:36.550,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,2,Are there any findings?,Auto,20510969,Closed,systemuser,30 Apr 2026 08:57:21:750,systemuser,30 Apr 2026 08:57:36:550,systemuser,30 Apr 2026 08:57:36:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:57:21.750,20260430 08:57:36.550,20260430 08:57:36.550,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,3,Are there any findings?,Auto,20510970,Closed,systemuser,30 Apr 2026 08:57:21:780,systemuser,30 Apr 2026 08:57:36:550,systemuser,30 Apr 2026 08:57:36:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:57:21.780,20260430 08:57:36.550,20260430 08:57:36.550,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,4,Are there any findings?,Auto,20510971,Closed,systemuser,30 Apr 2026 08:57:21:810,systemuser,30 Apr 2026 08:57:36:550,systemuser,30 Apr 2026 08:57:36:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:57:21.810,20260430 08:57:36.550,20260430 08:57:36.550,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Neurologic Examination,0/0/N,5,Are there any findings?,Auto,20510972,Closed,systemuser,30 Apr 2026 08:57:21:837,systemuser,30 Apr 2026 08:57:36:550,systemuser,30 Apr 2026 08:57:36:550,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:57:21.837,20260430 08:57:36.550,20260430 08:57:36.550,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 1.7 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20510769,Closed,systemuser,30 Apr 2026 08:43:38:517,systemuser,30 Apr 2026 08:43:48:103,systemuser,30 Apr 2026 08:43:48:107,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 08:43:38.517,20260430 08:43:48.103,20260430 08:43:48.107,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19072377,Closed,systemuser,19 Feb 2026 11:18:10:530,systemuser,19 Feb 2026 11:18:53:627,systemuser,19 Feb 2026 11:18:53:627,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260219 11:18:10.530,20260219 11:18:53.627,20260219 11:18:53.627,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Alcohol Test,0/0/N,,Alcohol Test Result,Auto,19317646,Closed,systemuser,05 Mar 2026 10:50:09:093,systemuser,05 Mar 2026 10:50:24:290,systemuser,05 Mar 2026 10:50:24:290,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:09.093,20260305 10:50:24.290,20260305 10:50:24.290,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Alcohol Test,0/0/N,,Collection Date,Auto,19317645,Closed,systemuser,05 Mar 2026 10:50:09:053,systemuser,05 Mar 2026 10:50:24:290,systemuser,05 Mar 2026 10:50:24:290,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:09.053,20260305 10:50:24.290,20260305 10:50:24.290,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Severity of illness,Auto,19317829,Closed,systemuser,05 Mar 2026 10:59:50:497,systemuser,05 Mar 2026 11:00:03:790,systemuser,05 Mar 2026 11:00:03:793,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:59:50.497,20260305 11:00:03.790,20260305 11:00:03.793,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Severity of illness,DM,19633579,Closed,JThoma858,23 Mar 2026 06:38:37:193,v.smidkova1,25 Mar 2026 12:28:07:200,JThoma858,26 Mar 2026 05:40:55:143,,2,1,Medical Review  I-3093914 ::Please  confirm accuracy of transposition from source to EDC.,data correct,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 06:38:37.193,20260325 12:28:07.200,20260326 05:40:55.143,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,19317827,Closed,systemuser,05 Mar 2026 10:59:50:480,systemuser,05 Mar 2026 11:00:03:817,systemuser,05 Mar 2026 11:00:03:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:59:50.480,20260305 11:00:03.817,20260305 11:00:03.817,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,19317828,Closed,systemuser,05 Mar 2026 10:59:50:490,systemuser,05 Mar 2026 11:00:03:817,systemuser,05 Mar 2026 11:00:03:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:59:50.490,20260305 11:00:03.817,20260305 11:00:03.817,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Ideation1. Wish to be Dead,Auto,19317653,Closed,systemuser,05 Mar 2026 10:50:41:100,systemuser,05 Mar 2026 10:51:10:453,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.100,20260305 10:51:10.453,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,2. Non-Specific Active Suicidal Thoughts,Auto,19317654,Closed,systemuser,05 Mar 2026 10:50:41:160,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.160,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal BehaviorActual Attempt,Auto,19317655,Closed,systemuser,05 Mar 2026 10:50:41:310,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.310,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,19317656,Closed,systemuser,05 Mar 2026 10:50:41:403,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.403,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Interrupted Attempt,Auto,19317657,Closed,systemuser,05 Mar 2026 10:50:41:460,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.460,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Aborted Attempt,Auto,19317658,Closed,systemuser,05 Mar 2026 10:50:41:537,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.537,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Preparatory Acts or Behavior,Auto,19317659,Closed,systemuser,05 Mar 2026 10:50:41:610,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:463,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.610,20260305 10:51:10.463,20260305 10:51:10.463,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Behavior,Auto,19317660,Closed,systemuser,05 Mar 2026 10:50:41:660,systemuser,05 Mar 2026 10:51:10:463,systemuser,05 Mar 2026 10:51:10:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.660,20260305 10:51:10.463,20260305 10:51:10.467,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicide,Auto,19317661,Closed,systemuser,05 Mar 2026 10:50:41:717,systemuser,05 Mar 2026 10:51:10:467,systemuser,05 Mar 2026 10:51:10:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.717,20260305 10:51:10.467,20260305 10:51:10.467,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Rater's Initials,Auto,19317652,Closed,systemuser,05 Mar 2026 10:50:41:073,systemuser,05 Mar 2026 10:51:10:467,systemuser,05 Mar 2026 10:51:10:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:41.073,20260305 10:51:10.467,20260305 10:51:10.467,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Was the collection date the same as the visit date?,Auto,19317651,Closed,systemuser,05 Mar 2026 10:50:40:910,systemuser,05 Mar 2026 10:51:10:467,systemuser,05 Mar 2026 10:51:10:467,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:50:40.910,20260305 10:51:10.467,20260305 10:51:10.467,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,19317636,Closed,systemuser,05 Mar 2026 10:49:21:193,systemuser,05 Mar 2026 10:49:58:557,systemuser,05 Mar 2026 10:49:58:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.193,20260305 10:49:58.557,20260305 10:49:58.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,19317637,Closed,systemuser,05 Mar 2026 10:49:21:203,systemuser,05 Mar 2026 10:49:58:560,systemuser,05 Mar 2026 10:49:58:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.203,20260305 10:49:58.560,20260305 10:49:58.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,19317638,Closed,systemuser,05 Mar 2026 10:49:21:210,systemuser,05 Mar 2026 10:49:58:560,systemuser,05 Mar 2026 10:49:58:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.210,20260305 10:49:58.560,20260305 10:49:58.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,19317639,Closed,systemuser,05 Mar 2026 10:49:21:220,systemuser,05 Mar 2026 10:49:58:560,systemuser,05 Mar 2026 10:49:58:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.220,20260305 10:49:58.560,20260305 10:49:58.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,19317640,Closed,systemuser,05 Mar 2026 10:49:21:227,systemuser,05 Mar 2026 10:49:58:560,systemuser,05 Mar 2026 10:49:58:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.227,20260305 10:49:58.560,20260305 10:49:58.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,19317635,Closed,systemuser,05 Mar 2026 10:49:21:180,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.180,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,19317641,Closed,systemuser,05 Mar 2026 10:49:21:233,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.233,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,19317643,Closed,systemuser,05 Mar 2026 10:49:21:250,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.250,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,19317642,Closed,systemuser,05 Mar 2026 10:49:21:243,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.243,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,19317644,Closed,systemuser,05 Mar 2026 10:49:21:260,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.260,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,19317634,Closed,systemuser,05 Mar 2026 10:49:21:160,systemuser,05 Mar 2026 10:49:58:587,systemuser,05 Mar 2026 10:49:58:587,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:49:21.160,20260305 10:49:58.587,20260305 10:49:58.587,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,19317679,Closed,systemuser,05 Mar 2026 10:52:33:937,systemuser,05 Mar 2026 10:53:24:177,systemuser,05 Mar 2026 10:53:24:180,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.937,20260305 10:53:24.177,20260305 10:53:24.180,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,19317680,Closed,systemuser,05 Mar 2026 10:52:33:950,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.950,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,19317681,Closed,systemuser,05 Mar 2026 10:52:33:960,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.960,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,19317682,Closed,systemuser,05 Mar 2026 10:52:33:967,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.967,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,19317683,Closed,systemuser,05 Mar 2026 10:52:33:973,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.973,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,19317684,Closed,systemuser,05 Mar 2026 10:52:33:980,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.980,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,19317685,Closed,systemuser,05 Mar 2026 10:52:33:990,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.990,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,19317678,Closed,systemuser,05 Mar 2026 10:52:33:923,systemuser,05 Mar 2026 10:53:24:183,systemuser,05 Mar 2026 10:53:24:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:52:33.923,20260305 10:53:24.183,20260305 10:53:24.183,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,19317825,Closed,systemuser,05 Mar 2026 10:59:14:790,systemuser,05 Mar 2026 10:59:30:303,systemuser,05 Mar 2026 10:59:30:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:59:14.790,20260305 10:59:30.303,20260305 10:59:30.307,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started the study medication, how are your depression symptoms?",Auto,19317844,Closed,systemuser,05 Mar 2026 11:00:20:817,systemuser,05 Mar 2026 11:00:41:803,systemuser,05 Mar 2026 11:00:41:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 11:00:20.817,20260305 11:00:41.803,20260305 11:00:41.807,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your difficulty falling asleep or staying asleep?",Auto,19317845,Closed,systemuser,05 Mar 2026 11:00:20:840,systemuser,05 Mar 2026 11:00:41:807,systemuser,05 Mar 2026 11:00:41:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 11:00:20.840,20260305 11:00:41.807,20260305 11:00:41.807,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your experience of not feeling rested the next day?",Auto,19317846,Closed,systemuser,05 Mar 2026 11:00:20:860,systemuser,05 Mar 2026 11:00:41:807,systemuser,05 Mar 2026 11:00:41:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 11:00:20.860,20260305 11:00:41.807,20260305 11:00:41.807,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your sleep problems?",Auto,19317847,Closed,systemuser,05 Mar 2026 11:00:20:890,systemuser,05 Mar 2026 11:00:41:807,systemuser,05 Mar 2026 11:00:41:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 11:00:20.890,20260305 11:00:41.807,20260305 11:00:41.807,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"If Yes, was the collection date the same as the visit date?",Auto,19317843,Closed,systemuser,05 Mar 2026 11:00:20:783,systemuser,05 Mar 2026 11:00:41:807,systemuser,05 Mar 2026 11:00:41:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 11:00:20.783,20260305 11:00:41.807,20260305 11:00:41.807,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,19317701,Closed,systemuser,05 Mar 2026 10:53:30:897,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.897,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,"2. Feeling down, depressed, or hopeless.",Auto,19317702,Closed,systemuser,05 Mar 2026 10:53:30:903,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.903,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,19317703,Closed,systemuser,05 Mar 2026 10:53:30:910,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.910,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,4. Feeling tired or having little energy.,Auto,19317704,Closed,systemuser,05 Mar 2026 10:53:30:920,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.920,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,5. Poor appetite or overeating.,Auto,19317705,Closed,systemuser,05 Mar 2026 10:53:30:927,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.927,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,19317706,Closed,systemuser,05 Mar 2026 10:53:30:933,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.933,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,19317707,Closed,systemuser,05 Mar 2026 10:53:30:940,systemuser,05 Mar 2026 10:54:21:373,systemuser,05 Mar 2026 10:54:21:373,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.940,20260305 10:54:21.373,20260305 10:54:21.373,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,19317708,Closed,systemuser,05 Mar 2026 10:53:30:947,systemuser,05 Mar 2026 10:54:21:377,systemuser,05 Mar 2026 10:54:21:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.947,20260305 10:54:21.377,20260305 10:54:21.377,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,19317709,Closed,systemuser,05 Mar 2026 10:53:30:953,systemuser,05 Mar 2026 10:54:21:377,systemuser,05 Mar 2026 10:54:21:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.953,20260305 10:54:21.377,20260305 10:54:21.377,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,19317710,Closed,systemuser,05 Mar 2026 10:53:30:960,systemuser,05 Mar 2026 10:54:21:377,systemuser,05 Mar 2026 10:54:21:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.960,20260305 10:54:21.377,20260305 10:54:21.377,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,Was the collection date the same as the visit date?,Auto,19317700,Closed,systemuser,05 Mar 2026 10:53:30:883,systemuser,05 Mar 2026 10:54:21:377,systemuser,05 Mar 2026 10:54:21:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:53:30.883,20260305 10:54:21.377,20260305 10:54:21.377,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,1. Loss of appetite,Auto,19317723,Closed,systemuser,05 Mar 2026 10:54:37:820,systemuser,05 Mar 2026 10:55:56:157,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.820,20260305 10:55:56.157,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,2. Nausea - Vomiting,Auto,19317724,Closed,systemuser,05 Mar 2026 10:54:37:827,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.827,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,3. Diarrhea,Auto,19317725,Closed,systemuser,05 Mar 2026 10:54:37:833,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.833,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"4. Anxiety, Nervousness",Auto,19317726,Closed,systemuser,05 Mar 2026 10:54:37:840,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.840,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,19317727,Closed,systemuser,05 Mar 2026 10:54:37:847,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.847,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"6. Dysphoric Mood, Depression",Auto,19317728,Closed,systemuser,05 Mar 2026 10:54:37:853,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.853,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,7. Insomnia,Auto,19317729,Closed,systemuser,05 Mar 2026 10:54:37:860,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.860,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,19317730,Closed,systemuser,05 Mar 2026 10:54:37:867,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.867,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,9. Poor Coordination,Auto,19317731,Closed,systemuser,05 Mar 2026 10:54:37:873,systemuser,05 Mar 2026 10:56:08:187,systemuser,05 Mar 2026 10:56:08:187,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.873,20260305 10:56:08.187,20260305 10:56:08.187,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"10. Restlessness, Agitation",Auto,19317732,Closed,systemuser,05 Mar 2026 10:54:37:880,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.880,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,11. Diaphoresis,Auto,19317733,Closed,systemuser,05 Mar 2026 10:54:37:890,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.890,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,12. Tremor - Tremulousness,Auto,19317734,Closed,systemuser,05 Mar 2026 10:54:37:943,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.943,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,13. Dizziness - Lightheadedness,Auto,19317735,Closed,systemuser,05 Mar 2026 10:54:37:950,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.950,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,14. Headaches,Auto,19317736,Closed,systemuser,05 Mar 2026 10:54:37:960,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.960,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,15. Muscle Aches or Stiffness,Auto,19317737,Closed,systemuser,05 Mar 2026 10:54:37:967,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.967,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,16. Weakness,Auto,19317738,Closed,systemuser,05 Mar 2026 10:54:37:973,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.973,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"17. Increased acuity for sound, smell, touch or pain",Auto,19317739,Closed,systemuser,05 Mar 2026 10:54:37:983,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.983,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,18. Paresthesias,Auto,19317740,Closed,systemuser,05 Mar 2026 10:54:37:990,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.990,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"19. Difficulty concentrating, remembering",Auto,19317741,Closed,systemuser,05 Mar 2026 10:54:38:000,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:38.000,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,"20. Depersonalization, Derealization",Auto,19317742,Closed,systemuser,05 Mar 2026 10:54:38:010,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:38.010,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,19317722,Closed,systemuser,05 Mar 2026 10:54:37:803,systemuser,05 Mar 2026 10:55:56:160,systemuser,05 Mar 2026 10:55:56:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:54:37.803,20260305 10:55:56.160,20260305 10:55:56.160,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,1. Reported Sadness,Auto,19317781,Closed,systemuser,05 Mar 2026 10:57:52:627,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.627,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,2. Apparent Sadness,Auto,19317782,Closed,systemuser,05 Mar 2026 10:57:52:633,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.633,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,3. Inner Tension,Auto,19317783,Closed,systemuser,05 Mar 2026 10:57:52:640,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.640,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,4. Reduced Sleep,Auto,19317784,Closed,systemuser,05 Mar 2026 10:57:52:650,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.650,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,5. Reduced Appetite,Auto,19317785,Closed,systemuser,05 Mar 2026 10:57:52:657,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.657,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,6. Concentration Difficulties,Auto,19317786,Closed,systemuser,05 Mar 2026 10:57:52:663,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.663,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,7. Lassitude,Auto,19317787,Closed,systemuser,05 Mar 2026 10:57:52:670,systemuser,05 Mar 2026 10:58:49:243,systemuser,05 Mar 2026 10:58:49:243,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.670,20260305 10:58:49.243,20260305 10:58:49.243,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,8. Inability to Feel,Auto,19317788,Closed,systemuser,05 Mar 2026 10:57:52:680,systemuser,05 Mar 2026 10:58:49:247,systemuser,05 Mar 2026 10:58:49:247,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.680,20260305 10:58:49.247,20260305 10:58:49.247,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,9. Pessimistic Thoughts,Auto,19317789,Closed,systemuser,05 Mar 2026 10:57:52:687,systemuser,05 Mar 2026 10:58:49:247,systemuser,05 Mar 2026 10:58:49:247,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.687,20260305 10:58:49.247,20260305 10:58:49.247,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,19317790,Closed,systemuser,05 Mar 2026 10:57:52:693,systemuser,05 Mar 2026 10:58:49:247,systemuser,05 Mar 2026 10:58:49:247,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.693,20260305 10:58:49.247,20260305 10:58:49.247,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,19317791,Closed,systemuser,05 Mar 2026 10:57:52:700,systemuser,05 Mar 2026 10:58:49:560,systemuser,05 Mar 2026 10:58:49:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.700,20260305 10:58:49.560,20260305 10:58:49.560,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Rater's Initials,Auto,19317780,Closed,systemuser,05 Mar 2026 10:57:52:617,systemuser,05 Mar 2026 10:58:49:267,systemuser,05 Mar 2026 10:58:49:267,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.617,20260305 10:58:49.267,20260305 10:58:49.267,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Was the collection date the same as the visit date?,Auto,19317779,Closed,systemuser,05 Mar 2026 10:57:52:607,systemuser,05 Mar 2026 10:58:49:267,systemuser,05 Mar 2026 10:58:49:267,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:57:52.607,20260305 10:58:49.267,20260305 10:58:49.267,94,335,335,32,231,713,713
CZE,S10-CZ10008,Clintrial s r o,CZ100080007,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19317618,Closed,systemuser,05 Mar 2026 10:46:59:773,systemuser,05 Mar 2026 10:48:32:553,systemuser,05 Mar 2026 10:48:32:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260305 10:46:59.773,20260305 10:48:32.553,20260305 10:48:32.553,94,335,335,32,231,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,What was the individual dose of the medication/therapy?,Auto,15236818,Closed,systemuser,08 Aug 2025 05:58:07:217,systemuser,08 Aug 2025 06:00:43:797,systemuser,08 Aug 2025 06:00:43:803,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 05:58:07.217,20250808 06:00:43.797,20250808 06:00:43.803,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,What was the individual dose of the medication/therapy?,Auto,15236876,Closed,systemuser,08 Aug 2025 06:00:44:210,MartaLendlova1,08 Aug 2025 06:03:49:983,shyamaprasad972,08 Aug 2025 07:22:31:427,,0,0,Dose contains a space or a comma or a non-numeric character; Please correct.,"This is an intrauterine device, so there is no dosing.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 06:00:44.210,20250808 06:03:49.983,20250808 07:22:31.427,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,What was the individual dose of the medication/therapy?,DM,15239278,Closed,shyamaprasad972,08 Aug 2025 07:23:07:653,MartaLendlova1,08 Aug 2025 09:00:41:547,shyamaprasad972,11 Aug 2025 07:21:06:937,,0,3,RQ-DM1: Thank you for the response. Please update the response as 1 in the field 'What was the individual dose of the medication/therapy?' and update the response as 'Implant' in the field 'Dose Unit' and Dose Form.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 07:23:07.653,20250808 09:00:41.547,20250811 07:21:06.937,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,What was the individual dose of the medication/therapy?,Auto,15247692,Closed,systemuser,08 Aug 2025 09:00:28:560,,,systemuser,08 Aug 2025 09:01:51:180,,,0,Dose contains a space or a comma or a non-numeric character; Please correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:00:28.560,,20250808 09:01:51.180,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,What was the individual dose of the medication/therapy?,DM,15273811 (15239278),Closed,shyamaprasad972,11 Aug 2025 07:21:07:050,MartaLendlova1,15 Aug 2025 08:39:11:510,shyamaprasad972,19 Aug 2025 06:44:46:623,,4,4,"RQ-DM2: Thank you for the response. However, kindly update the response as  'Implant' in the field 'Dose Unit'. ",corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250811 07:21:07.050,20250815 08:39:11.510,20250819 06:44:46.623,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,Indication,Auto,15236817,Closed,systemuser,08 Aug 2025 05:58:07:207,systemuser,08 Aug 2025 06:00:12:437,systemuser,08 Aug 2025 06:00:12:453,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 05:58:07.207,20250808 06:00:12.437,20250808 06:00:12.453,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,4,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,15421630,Closed,systemuser,20 Aug 2025 16:51:58:490,MartaLendlova1,20 Aug 2025 16:53:57:603,Ashwini201,21 Aug 2025 08:14:41:870,,0,1,The selected logline has been modified from  '#001 > APPENDECTOMY' to '#001 > ACUTE APPENDICITIS' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250820 16:51:58.490,20250820 16:53:57.603,20250821 08:14:41.870,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Indication,Auto,15356053,Closed,systemuser,15 Aug 2025 08:56:25:450,systemuser,15 Aug 2025 08:57:23:377,systemuser,15 Aug 2025 08:57:23:377,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250815 08:56:25.450,20250815 08:57:23.377,20250815 08:57:23.377,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Indication,Auto,15356083,Closed,systemuser,15 Aug 2025 08:57:43:430,systemuser,15 Aug 2025 08:58:05:550,systemuser,15 Aug 2025 08:58:05:553,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250815 08:57:43.430,20250815 08:58:05.550,20250815 08:58:05.553,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,End of Study (1),Date of Visit,0/0/N,,Did this visit occur?,Auto,17453011,Closed,systemuser,01 Dec 2025 17:43:11:063,systemuser,05 Dec 2025 11:48:57:343,systemuser,05 Dec 2025 11:48:57:363,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251201 17:43:11.063,20251205 11:48:57.343,20251205 11:48:57.363,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251120 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,17118259,Closed,systemuser,20 Nov 2025 08:14:42:940,systemuser,20 Nov 2025 09:59:58:090,systemuser,20 Nov 2025 09:59:58:210,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251120 08:14:42.940,20251120 09:59:58.090,20251120 09:59:58.210,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20935912,Cancelled,systemuser,20 May 2026 13:55:51:393,,,ipanis1,21 May 2026 12:41:09:763,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 13:55:51.393,,20260521 12:41:09.763,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Drug Expiry Information,0/0/N,,Did the subject take all investigational medication within the expiry timeframe?,Auto,17118276,Closed,systemuser,20 Nov 2025 08:15:36:137,MartaLendlova1,20 Nov 2025 08:15:47:580,Ashwini201,21 Nov 2025 10:16:42:073,,0,1,Required field.  Please complete or provide a response.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251120 08:15:36.137,20251120 08:15:47.580,20251121 10:16:42.073,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Drug Expiry Information,0/0/N,,Did the subject take all investigational medication within the expiry timeframe?,DM,17186897,Closed,Ashwini201,21 Nov 2025 10:18:20:533,NadaTruhlarova1,22 Nov 2025 11:56:53:123,Ashwini201,24 Nov 2025 07:02:08:863,,1,2,RQ-DM1: Please verify and update the data in this field.,The data verified and updated. ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251121 10:18:20.533,20251122 11:56:53.123,20251124 07:02:08.863,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,2,Start date of menstrual period,DM,20567114,Closed,JThoma858,30 Apr 2026 12:46:25:327,NadaTruhlarova1,04 May 2026 09:09:26:717,JThoma858,05 May 2026 05:15:12:547,,4,1,DM: Kindly update the menstrual cycle data for the month of Aug and Oct 2025. ,Updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260430 12:46:25.327,20260504 09:09:26.717,20260505 05:15:12.547,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16327407,Closed,systemuser,08 Oct 2025 19:56:55:133,,,systemuser,12 Oct 2025 15:38:10:670,,,4,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251008 19:56:55.133,,20251012 15:38:10.670,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/V,,What was the subject's primary reason for treatment discontinuation/completion?,DM,19657441,Closed,JThoma858,24 Mar 2026 06:54:37:903,NadaTruhlarova1,24 Mar 2026 11:44:30:710,JThoma858,26 Mar 2026 05:41:44:720,,0,2,Medical Review I-3093909: Patient  completed DB Part 1 and withdrew at exactly the decision point between Part 1 and Part 2. Please revise response in line with study conventions to be a completer.,Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260324 06:54:37.903,20260324 11:44:30.710,20260326 05:41:44.720,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Treatment Disposition - Part 1,0/0/V,,Treatment Disposition Date,DM,16517078,Closed,Juhita@ksha4,22 Oct 2025 07:12:09:770,MartaLendlova1,23 Oct 2025 09:02:51:250,Juhita@ksha4,24 Oct 2025 11:52:23:007,,1,1,Medical Review I-273551: Please complete Treatment disposition page.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 07:12:09.770,20251023 09:02:51.250,20251024 11:52:23.007,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,What was the subject's primary reason for trial discontinuation/completion?,Site from Medical Reviewer,17333579,Closed,joetrombello1,26 Nov 2025 17:52:37:963,MartaLendlova1,01 Dec 2025 17:35:04:007,joetrombello1,02 Dec 2025 14:58:05:663,,5,1,"medical reviewer: By convention, pts. who complete both f/u visits are considered trial &quot;completers&quot;. Please review the form completion guidelines and also review and revise the response.",corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251126 17:52:37.963,20251201 17:35:04.007,20251202 14:58:05.663,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,18173512,Closed,Ashwini201,23 Dec 2025 07:17:55:430,NadaTruhlarova1,23 Dec 2025 14:35:43:650,shyamaprasad972,24 Dec 2025 07:38:59:883,,0,1,"DM: Please complete or inactivate Comments and Unsuccessful Contact Attempts forms, Else clarify.",Comments and Unsuccessful Contact Attempts forms inactivated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:17:55.430,20251223 14:35:43.650,20251224 07:38:59.883,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,15765141,Closed,Ashwini201,02 Sep 2025 15:42:42:853,MartaLendlova1,07 Sep 2025 07:54:03:647,Ashwini201,11 Sep 2025 11:37:55:803,,5,4,DM: Please complete the 'Menstrual Cycle Tracking Log' form in 'Screening to end of study' folder.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250902 15:42:42.853,20250907 07:54:03.647,20250911 11:37:55.803,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,16124928,Closed,Ashwini201,24 Sep 2025 13:37:04:047,MartaLendlova1,30 Sep 2025 05:38:48:727,Ashwini201,30 Sep 2025 08:07:27:643,,6,0,DM: Kindly update the 'Arizona Sexual Experiences Scale Summary' form.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 13:37:04.047,20250930 05:38:48.727,20250930 08:07:27.643,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18173531,Closed,Ashwini201,23 Dec 2025 07:19:24:327,NadaTruhlarova1,23 Dec 2025 14:32:58:843,shyamaprasad972,24 Dec 2025 07:44:13:303,,0,1,DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.,Updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:19:24.327,20251223 14:32:58.843,20251224 07:44:13.303,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Demographics,0/0/V,,What is the protocol date the subject consented to at study start?,SM,16298605,Closed,Mamaking4,07 Oct 2025 10:42:32:343,NadaTruhlarova1,08 Oct 2025 17:32:59:987,Mamaking4,15 Oct 2025 10:53:42:833,,1,7,"Please, correct the date to 17 Mar 2025",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:42:32.343,20251008 17:32:59.987,20251015 10:53:42.833,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Demographics,0/0/V,,What is the ethnicity of the subject?,Auto,15218970,Closed,systemuser,07 Aug 2025 08:52:55:273,systemuser,07 Aug 2025 08:53:42:960,systemuser,07 Aug 2025 08:53:42:963,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 08:52:55.273,20250807 08:53:42.960,20250807 08:53:42.963,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Demographics,0/0/V,,American Indian or Alaska Native,Auto,15218971,Closed,systemuser,07 Aug 2025 08:52:55:283,systemuser,07 Aug 2025 08:53:50:533,systemuser,07 Aug 2025 08:53:50:533,,0,0,A race category is not reported. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 08:52:55.283,20250807 08:53:50.533,20250807 08:53:50.533,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,15219966,Closed,systemuser,07 Aug 2025 09:37:00:193,systemuser,07 Aug 2025 09:38:27:560,systemuser,07 Aug 2025 09:38:27:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.193,20250807 09:38:27.560,20250807 09:38:27.560,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,15219967,Closed,systemuser,07 Aug 2025 09:37:00:200,systemuser,07 Aug 2025 09:38:27:560,systemuser,07 Aug 2025 09:38:27:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.200,20250807 09:38:27.560,20250807 09:38:27.560,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,15219968,Closed,systemuser,07 Aug 2025 09:37:00:210,systemuser,07 Aug 2025 09:38:27:560,systemuser,07 Aug 2025 09:38:27:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.210,20250807 09:38:27.560,20250807 09:38:27.560,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,15219969,Closed,systemuser,07 Aug 2025 09:37:00:217,systemuser,07 Aug 2025 09:38:27:560,systemuser,07 Aug 2025 09:38:27:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.217,20250807 09:38:27.560,20250807 09:38:27.560,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,15219970,Closed,systemuser,07 Aug 2025 09:37:00:227,systemuser,07 Aug 2025 09:38:27:560,systemuser,07 Aug 2025 09:38:27:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.227,20250807 09:38:27.560,20250807 09:38:27.560,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Collection Time,Auto,15219965,Closed,systemuser,07 Aug 2025 09:37:00:183,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.183,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,15219971,Closed,systemuser,07 Aug 2025 09:37:00:233,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.233,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,15219973,Closed,systemuser,07 Aug 2025 09:37:00:253,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.253,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,15219972,Closed,systemuser,07 Aug 2025 09:37:00:243,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.243,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,15219974,Closed,systemuser,07 Aug 2025 09:37:00:267,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.267,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,15219964,Closed,systemuser,07 Aug 2025 09:37:00:163,systemuser,07 Aug 2025 09:38:27:573,systemuser,07 Aug 2025 09:38:27:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 09:37:00.163,20250807 09:38:27.573,20250807 09:38:27.573,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,General Medical History,0/0/N,1,Is the medical history disease/condition or event still ongoing?,Auto,15225818,Closed,systemuser,07 Aug 2025 13:11:07:087,systemuser,08 Aug 2025 05:50:31:440,systemuser,08 Aug 2025 05:50:31:440,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 13:11:07.087,20250808 05:50:31.440,20250808 05:50:31.440,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Auto,15225817,Closed,systemuser,07 Aug 2025 13:11:07:060,,08 Aug 2025 05:50:31:500,systemuser,08 Aug 2025 05:50:31:500,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250807 13:11:07.060,20250808 05:50:31.500,20250808 05:50:31.500,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,15382939,Closed,inayath1,19 Aug 2025 06:20:23:273,MartaLendlova1,20 Aug 2025 16:52:05:820,inayath1,21 Aug 2025 09:07:35:593,,1,1,Eligibility: Please provide the indication for the surgery and update the same in separate logline of MH log.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250819 06:20:23.273,20250820 16:52:05.820,20250821 09:07:35.593,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,15463489 (15382939),Closed,inayath1,21 Aug 2025 09:07:35:727,MartaLendlova1,07 Sep 2025 08:01:14:873,meghal.choksi@iqvia.com1,18 Sep 2025 11:12:48:190,,17,11,Eligibility: Please update diagnosis and surgery in separate loglines.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250821 09:07:35.727,20250907 08:01:14.873,20250918 11:12:48.190,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,General Medical History,0/0/N,2,Start Date,Auto,15356018,Closed,systemuser,15 Aug 2025 08:50:52:893,,,systemuser,15 Aug 2025 08:51:01:230,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250815 08:50:52.893,,20250815 08:51:01.230,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",Auto,15236732,Closed,systemuser,08 Aug 2025 05:54:09:257,systemuser,08 Aug 2025 06:01:54:780,systemuser,08 Aug 2025 06:01:54:783,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 05:54:09.257,20250808 06:01:54.780,20250808 06:01:54.783,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Neurologic Examination,0/0/N,,Date of Assessment,Auto,15845561,Closed,systemuser,07 Sep 2025 07:31:21:420,systemuser,07 Sep 2025 07:31:57:530,systemuser,07 Sep 2025 07:31:57:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250907 07:31:21.420,20250907 07:31:57.530,20250907 07:31:57.530,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,15845555,Closed,systemuser,07 Sep 2025 07:21:37:317,systemuser,07 Sep 2025 07:21:44:817,systemuser,07 Sep 2025 07:21:44:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250907 07:21:37.317,20250907 07:21:44.817,20250907 07:21:44.817,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Subject's Status,Auto,15257983,Closed,systemuser,08 Aug 2025 16:27:52:630,MartaLendlova1,08 Aug 2025 16:28:38:130,shyamaprasad972,11 Aug 2025 07:24:46:243,,0,3,Required field.  Please complete or provide a response.,entered by accident,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 16:27:52.630,20250808 16:28:38.130,20250811 07:24:46.243,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,Auto,15257982,Closed,systemuser,08 Aug 2025 16:27:52:620,MartaLendlova1,08 Aug 2025 16:28:35:193,Ashwini201,13 Aug 2025 11:11:19:590,,0,5,Required field.  Please complete or provide a response.,entered by accident,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 16:27:52.620,20250808 16:28:35.193,20250813 11:11:19.590,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Did this visit occur?,DM,15273963,Cancelled,shyamaprasad972,11 Aug 2025 07:27:21:003,,,kminarov1,26 Aug 2025 08:07:40:087,,,,RQ-DM1: Thank you for the response. Please verify and update the response once available.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250811 07:27:21.003,,20250826 08:07:40.087,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15257981,Closed,systemuser,08 Aug 2025 16:27:21:570,MartaLendlova1,08 Aug 2025 16:28:40:350,shyamaprasad972,11 Aug 2025 07:24:48:060,,0,3,Date of visit should be greater than the last date of visit. Please reconcile.,entered by accident,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 16:27:21.570,20250808 16:28:40.350,20250811 07:24:48.060,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,15257984,Closed,systemuser,08 Aug 2025 16:27:52:637,MartaLendlova1,08 Aug 2025 16:28:43:867,shyamaprasad972,11 Aug 2025 07:24:55:693,,0,3,Required field.  Please complete or provide a response.,entered by accident,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 16:27:52.637,20250808 16:28:43.867,20250811 07:24:55.693,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Number of tablets taken,Auto,15845577,Closed,systemuser,07 Sep 2025 08:02:53:943,MartaLendlova1,09 Sep 2025 07:23:44:487,shyamaprasad972,12 Sep 2025 08:23:55:757,,2,3,Required field.  Please complete or provide a response.,na,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250907 08:02:53.943,20250909 07:23:44.487,20250912 08:23:55.757,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,15650172,Closed,systemuser,28 Aug 2025 07:34:31:897,,,systemuser,07 Sep 2025 08:02:53:727,,,10,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 07:34:31.897,,20250907 08:02:53.727,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,15870354,Closed,systemuser,09 Sep 2025 07:23:36:187,MartaLendlova1,09 Sep 2025 07:24:06:283,shyamaprasad972,12 Sep 2025 08:24:08:187,,0,3,Please enter study drug administration start date as soon as it's available,Will be completed after next on site visit,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 07:23:36.187,20250909 07:24:06.283,20250912 08:24:08.187,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,DM,15940159,Closed,shyamaprasad972,12 Sep 2025 08:25:08:863,MartaLendlova1,12 Sep 2025 09:23:29:170,Ashwini201,19 Sep 2025 09:17:20:387,,0,7,"RQ-DM1: Thank you for the response. However, please verify and update the data once available.",Completed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250912 08:25:08.863,20250912 09:23:29.170,20250919 09:17:20.387,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,DM,16398914,Closed,Ashwini201,14 Oct 2025 13:41:56:390,NadaTruhlarova1,15 Oct 2025 16:50:32:153,Ashwini201,16 Oct 2025 08:35:40:160,,1,1,"DM: Please inactivate Log line 2 and 3. If one tablet is consistently taken daily, then only 1 logline should be used with corresponding start and end dates.  Other log lines only needed for missed doses or overdose with start and end dates. Please review completion guideline Study Drug Administration Double Blind Part 1 and update the data as appropriate.",Log line 2 and 3 inactivated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251014 13:41:56.390,20251015 16:50:32.153,20251016 08:35:40.160,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,16602971,Closed,Ashwini201,27 Oct 2025 13:08:35:077,NadaTruhlarova1,03 Nov 2025 07:59:03:883,Ashwini201,04 Nov 2025 09:06:38:443,,7,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 13:08:35.077,20251103 07:59:03.883,20251104 09:06:38.443,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,15870351,Closed,systemuser,09 Sep 2025 07:23:36:167,MartaLendlova1,12 Sep 2025 09:11:38:497,shyamaprasad972,15 Sep 2025 07:50:09:567,,3,3,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Completed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250909 07:23:36.167,20250912 09:11:38.497,20250915 07:50:09.567,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,16425077,Closed,systemuser,15 Oct 2025 16:48:19:623,systemuser,15 Oct 2025 16:49:23:440,systemuser,15 Oct 2025 16:49:23:457,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 16:48:19.623,20251015 16:49:23.440,20251015 16:49:23.457,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,16425087,Closed,systemuser,15 Oct 2025 16:48:52:987,systemuser,15 Oct 2025 16:49:23:457,systemuser,15 Oct 2025 16:49:23:457,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 16:48:52.987,20251015 16:49:23.457,20251015 16:49:23.457,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,16425116,Closed,systemuser,15 Oct 2025 16:49:40:390,systemuser,15 Oct 2025 16:49:50:893,systemuser,15 Oct 2025 16:49:50:910,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 16:49:40.390,20251015 16:49:50.893,20251015 16:49:50.910,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,16425117,Closed,systemuser,15 Oct 2025 16:49:40:397,systemuser,15 Oct 2025 16:49:58:643,systemuser,15 Oct 2025 16:49:58:653,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 16:49:40.397,20251015 16:49:58.643,20251015 16:49:58.653,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,15715736,Closed,systemuser,29 Aug 2025 10:58:06:793,systemuser,29 Aug 2025 10:58:20:097,systemuser,29 Aug 2025 10:58:20:097,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:58:06.793,20250829 10:58:20.097,20250829 10:58:20.097,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,5,Are there any findings?,Auto,15715738,Closed,systemuser,29 Aug 2025 10:58:08:250,systemuser,29 Aug 2025 10:58:26:963,systemuser,29 Aug 2025 10:58:26:963,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:58:08.250,20250829 10:58:26.963,20250829 10:58:26.963,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,15715491,Closed,systemuser,29 Aug 2025 10:39:40:040,systemuser,29 Aug 2025 10:39:50:697,systemuser,29 Aug 2025 10:39:50:700,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:39:40.040,20250829 10:39:50.697,20250829 10:39:50.700,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Body Mass Index,Auto,15715429,Closed,systemuser,29 Aug 2025 10:36:49:327,systemuser,29 Aug 2025 10:38:12:403,systemuser,29 Aug 2025 10:38:12:403,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.327,20250829 10:38:12.403,20250829 10:38:12.403,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,15715433,Closed,systemuser,29 Aug 2025 10:36:49:390,systemuser,29 Aug 2025 10:38:12:413,systemuser,29 Aug 2025 10:38:12:413,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.390,20250829 10:38:12.413,20250829 10:38:12.413,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Pulse,Auto,15715431,Closed,systemuser,29 Aug 2025 10:36:49:357,systemuser,29 Aug 2025 10:38:12:423,systemuser,29 Aug 2025 10:38:12:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.357,20250829 10:38:12.423,20250829 10:38:12.423,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Pulse,Auto,15715467,Closed,systemuser,29 Aug 2025 10:38:12:510,systemuser,29 Aug 2025 10:38:54:207,systemuser,29 Aug 2025 10:38:54:207,,0,0,The 'Pulse' is not within the range of '50' to '100'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:38:12.510,20250829 10:38:54.207,20250829 10:38:54.207,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,15715432,Closed,systemuser,29 Aug 2025 10:36:49:373,systemuser,29 Aug 2025 10:38:12:430,systemuser,29 Aug 2025 10:38:12:430,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.373,20250829 10:38:12.430,20250829 10:38:12.430,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,15715468,Closed,systemuser,29 Aug 2025 10:38:12:527,systemuser,29 Aug 2025 10:38:54:207,systemuser,29 Aug 2025 10:38:54:207,,0,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:38:12.527,20250829 10:38:54.207,20250829 10:38:54.207,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,15715427,Closed,systemuser,29 Aug 2025 10:36:49:283,systemuser,29 Aug 2025 10:38:12:430,systemuser,29 Aug 2025 10:38:12:430,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.283,20250829 10:38:12.430,20250829 10:38:12.430,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature,Auto,15715430,Closed,systemuser,29 Aug 2025 10:36:49:343,systemuser,29 Aug 2025 10:38:12:430,systemuser,29 Aug 2025 10:38:12:430,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.343,20250829 10:38:12.430,20250829 10:38:12.430,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15715466,Closed,systemuser,29 Aug 2025 10:38:12:497,systemuser,29 Aug 2025 10:38:21:307,systemuser,29 Aug 2025 10:38:21:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:38:12.497,20250829 10:38:21.307,20250829 10:38:21.307,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Weight,Auto,15715428,Closed,systemuser,29 Aug 2025 10:36:49:313,systemuser,29 Aug 2025 10:38:12:430,systemuser,29 Aug 2025 10:38:12:430,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250829 10:36:49.313,20250829 10:38:12.430,20250829 10:38:12.430,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 6 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,15941399,Closed,systemuser,12 Sep 2025 09:18:43:987,systemuser,12 Sep 2025 09:18:51:803,systemuser,12 Sep 2025 09:18:51:807,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250912 09:18:43.987,20250912 09:18:51.803,20250912 09:18:51.807,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature,Auto,16174519,Closed,systemuser,26 Sep 2025 10:02:03:113,systemuser,26 Sep 2025 10:02:23:277,systemuser,26 Sep 2025 10:02:23:280,,0,0,The 'Temperature' is not within the range of '35.5' to '37.7' degrees of Celsius. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250926 10:02:03.113,20250926 10:02:23.277,20250926 10:02:23.280,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,DM,19633635,Closed,JThoma858,23 Mar 2026 06:41:07:700,NadaTruhlarova1,24 Mar 2026 11:42:44:083,JThoma858,25 Mar 2026 05:50:25:590,,1,1,Medical Review vI-3093913; Please  confirm accuracy of transposition from source to EDC.,Confirmed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 06:41:07.700,20260324 11:42:44.083,20260325 05:50:25.590,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110001,Completed,Visit 8 Part 1 (1),Date of Visit,0/0/N,,Subject's Status,Auto,17452948,Closed,systemuser,01 Dec 2025 17:34:53:810,NadaTruhlarova1,05 Dec 2025 12:08:41:520,Ashwini201,09 Dec 2025 10:13:40:717,,4,4,"Trial Disposition is ""Completed"" on the Trial Disposition (Completion/ Discontinuation) form, however, the Subject Status on the Last Date of Visit is not ""Completed Study"". Please resolve.",Resolved.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251201 17:34:53.810,20251205 12:08:41.520,20251209 10:13:40.717,89,335,335,26,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,1,What is the adverse event term?,DM,17586940,Closed,Juhita@ksha4,04 Dec 2025 10:56:19:173,NadaTruhlarova1,05 Dec 2025 11:46:09:810,Juhita@ksha4,08 Dec 2025 07:22:48:167,,1,3,"Medical Review I-941086: Kindly clarify time of the day when AE occurs, if it is continuous or intermittent and if it affect daily routine activity.","The subject reported a single occurrence, in the morning, which resolved spontaneously within 1 hour. The subject was unable to perform normal activities during vertigo.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 10:56:19.173,20251205 11:46:09.810,20251208 07:22:48.167,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Is this an AE of special interest as per protocol?,Auto,16866319,Closed,systemuser,07 Nov 2025 21:00:47:330,systemuser,11 Nov 2025 11:21:41:757,systemuser,11 Nov 2025 11:21:41:757,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 21:00:47.330,20251111 11:21:41.757,20251111 11:21:41.757,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,2,Relationship to Study Treatment,DM,18328023,Closed,Juhita@ksha4,07 Jan 2026 09:41:14:020,NadaTruhlarova1,17 Jan 2026 07:52:47:780,Juhita@ksha4,19 Jan 2026 07:42:59:577,,10,2,Medical Review I-1712928: Kindly clarify rationality to consider AE to be related to study drug.,The subject described akathisia in the morning after administration of the study drug; he had never experienced similar problems before.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 09:41:14.020,20260117 07:52:47.780,20260119 07:42:59.577,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,"If Yes, Medication or Therapy",Auto,15244784,Closed,systemuser,08 Aug 2025 08:39:13:280,systemuser,08 Aug 2025 08:39:46:150,systemuser,08 Aug 2025 08:39:46:153,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 08:39:13.280,20250808 08:39:46.150,20250808 08:39:46.153,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,4,Is the medication/therapy still ongoing?,DM,19724027,Closed,JThoma858,26 Mar 2026 11:57:55:950,MartaLendlova1,01 Apr 2026 14:41:20:587,JThoma858,02 Apr 2026 05:50:22:450,,6,1,"DM: Please note the drug is given for current episode of depression and recorded in MGH ATRQ-Non Geriatric Section I and II , however the drug is not ongoing in CM form. As per guidance &quot; End Date should be blank (if there are multiple records, then previous record may have end date/dose change, but current record should match MGH-ATRQ&quot;'. Kindly recheck and verify. Else clarify",This is a record related to a change in dosage.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 11:57:55.950,20260401 14:41:20.587,20260402 05:50:22.450,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Follow-up 7-14 Days After (1),Date of Visit,0/0/N,,Did this visit occur?,DM,19562585,Closed,Ashwini201,17 Mar 2026 15:01:25:353,NadaTruhlarova1,17 Mar 2026 17:11:18:357,Ashwini201,18 Mar 2026 12:51:46:537,,0,1,"DM: Please verify and update the data on all blank forms of Follow-up 7-14 Days After, else clarify.",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 15:01:25.353,20260317 17:11:18.357,20260318 12:51:46.537,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Follow-up 7-14 Days After (1),Patient Health Questionnaire - 9 Item,0/0/V,,Reason Not Done,Auto,19566136,Closed,systemuser,17 Mar 2026 17:07:40:233,systemuser,17 Mar 2026 17:09:08:680,systemuser,17 Mar 2026 17:09:08:680,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 17:07:40.233,20260317 17:09:08.680,20260317 17:09:08.680,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260117 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18487363,Closed,systemuser,16 Jan 2026 15:06:36:150,systemuser,17 Jan 2026 07:54:21:970,systemuser,17 Jan 2026 07:54:22:087,,1,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 15:06:36.150,20260117 07:54:21.970,20260117 07:54:22.087,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260127 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18641871,Closed,systemuser,27 Jan 2026 17:03:59:410,systemuser,27 Jan 2026 17:10:47:743,systemuser,27 Jan 2026 17:10:47:863,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260127 17:03:59.410,20260127 17:10:47.743,20260127 17:10:47.863,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20935921,Cancelled,systemuser,20 May 2026 13:56:23:217,,,ipanis1,21 May 2026 12:41:44:810,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 13:56:23.217,,20260521 12:41:44.810,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,16363285,Closed,systemuser,10 Oct 2025 20:49:36:910,,,systemuser,10 Oct 2025 20:57:35:693,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 20:49:36.910,,20251010 20:57:35.693,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,Treatment Disposition Date,DM,18764252,Closed,Juhita@ksha4,04 Feb 2026 11:28:45:340,NadaTruhlarova1,04 Feb 2026 16:53:19:577,Juhita@ksha4,05 Feb 2026 09:22:14:570,,0,1,"Medical Review I-1902309: Please review and revise date response, as per guidelines this should be the date tied to a study visit when the patient discontinued study treatment.",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260204 11:28:45.340,20260204 16:53:19.577,20260205 09:22:14.570,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,Treatment Disposition Date,DM,18907286,Closed,Juhita@ksha4,12 Feb 2026 11:49:50:067,NadaTruhlarova1,16 Feb 2026 10:39:15:577,Juhita@ksha4,20 Feb 2026 10:36:17:983,,4,4,"RQ MR1 I-1902309: This date is in fact incorrect as a response to this form, which is intended as the study visit date where medication was discontinued. Please review and revise, consulting SM as necessary.",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 11:49:50.067,20260216 10:39:15.577,20260220 10:36:17.983,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,18598914,Closed,Juhita@ksha4,23 Jan 2026 13:58:47:533,NadaTruhlarova1,27 Jan 2026 17:04:58:097,Juhita@ksha4,30 Jan 2026 09:29:19:183,,4,3,Medical Review I-1828045: Please complete disposition page.,Completed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260123 13:58:47.533,20260127 17:04:58.097,20260130 09:29:19.183,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,Disposition Date,DM,19562572,Closed,Ashwini201,17 Mar 2026 15:00:45:483,NadaTruhlarova1,22 Mar 2026 19:56:19:763,shyamaprasad972,23 Mar 2026 08:28:29:350,,5,1,"DM: Please verify and update the data on all blank forms of Screening to end of study, else clarify.",Updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 15:00:45.483,20260322 19:56:19.763,20260323 08:28:29.350,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Suicidal Ideation1. Wish to be DeadLifetime,Auto,15248711,Closed,systemuser,08 Aug 2025 09:24:20:183,systemuser,08 Aug 2025 09:26:20:513,systemuser,08 Aug 2025 09:26:20:513,,0,0,"The 'Past_Months' is reported as 'Yes' for '1. Suicidal Ideation Wish to be dead', however, the 'Lifetime' is marked as 'No'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:24:20.183,20250808 09:26:20.513,20250808 09:26:20.513,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248712,Closed,systemuser,08 Aug 2025 09:24:20:197,systemuser,08 Aug 2025 09:26:20:510,systemuser,08 Aug 2025 09:26:20:513,,0,0,This behavior occurred within the last 6 months/1 year but is reported as 'No' within the patient's lifetime.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:24:20.197,20250808 09:26:20.510,20250808 09:26:20.513,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Intensity of IdeationMost Severe IdeationLifetime,Auto,15248773,Closed,systemuser,08 Aug 2025 09:26:20:557,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.557,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Intensity of IdeationMost Severe IdeationLifetime,Auto,15263406,Closed,systemuser,10 Aug 2025 16:57:39:377,systemuser,10 Aug 2025 16:59:03:683,systemuser,10 Aug 2025 16:59:03:687,,0,0,The most severe ideation selected does not match with the suicidal ideations above.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 16:57:39.377,20250810 16:59:03.683,20250810 16:59:03.687,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Intensity of IdeationMost Severe IdeationLifetime,Auto,15263407,Closed,systemuser,10 Aug 2025 16:57:39:380,,,systemuser,10 Aug 2025 16:59:03:703,,,0,The Intesity of Ideation entered does not match the highest endorsed suicidal ideation above.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250810 16:57:39.380,,20250810 16:59:03.703,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248774,Closed,systemuser,08 Aug 2025 09:26:20:563,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.563,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,FrequencyLifetime,Auto,15248775,Closed,systemuser,08 Aug 2025 09:26:20:573,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.573,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248776,Closed,systemuser,08 Aug 2025 09:26:20:577,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.577,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,DurationLifetime,Auto,15248777,Closed,systemuser,08 Aug 2025 09:26:20:587,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.587,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248778,Closed,systemuser,08 Aug 2025 09:26:20:590,systemuser,10 Aug 2025 16:57:39:333,systemuser,10 Aug 2025 16:57:39:333,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.590,20250810 16:57:39.333,20250810 16:57:39.333,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,ControllabilityLifetime,Auto,15248779,Closed,systemuser,08 Aug 2025 09:26:20:597,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.597,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248780,Closed,systemuser,08 Aug 2025 09:26:20:603,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.603,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,DeterrentsLifetime,Auto,15248781,Closed,systemuser,08 Aug 2025 09:26:20:613,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.613,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248782,Closed,systemuser,08 Aug 2025 09:26:20:620,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.620,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Reasons for IdeationLifetime,Auto,15248783,Closed,systemuser,08 Aug 2025 09:26:20:627,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.627,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,15248784,Closed,systemuser,08 Aug 2025 09:26:20:633,systemuser,10 Aug 2025 16:57:39:337,systemuser,10 Aug 2025 16:57:39:337,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:26:20.633,20250810 16:57:39.337,20250810 16:57:39.337,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,16124971,Closed,Ashwini201,24 Sep 2025 13:38:54:843,MartaLendlova1,30 Sep 2025 05:39:01:083,Ashwini201,30 Sep 2025 08:08:26:463,,6,0,DM: Kindly update the 'Arizona Sexual Experiences Scale Summary' form.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250924 13:38:54.843,20250930 05:39:01.083,20250930 08:08:26.463,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Demographics,0/0/V,,What was the date of the signature on informed consent?,Auto,15247851,Closed,systemuser,08 Aug 2025 09:04:14:663,systemuser,08 Aug 2025 09:08:38:483,systemuser,08 Aug 2025 09:08:38:483,,0,0,Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:04:14.663,20250808 09:08:38.483,20250808 09:08:38.483,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Demographics,0/0/V,,Sex reported at birth,Auto,15247853,Closed,systemuser,08 Aug 2025 09:04:14:763,systemuser,08 Aug 2025 09:05:41:677,systemuser,08 Aug 2025 09:05:41:713,,0,0,"Sex reported at birth is 'Male. However, What is the subject's childbearing potential? is selected other than 'Not Applicable'. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:04:14.763,20250808 09:05:41.677,20250808 09:05:41.713,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Demographics,0/0/V,,What is the protocol date the subject consented to at study start?,Auto,15247852,Closed,systemuser,08 Aug 2025 09:04:14:717,systemuser,08 Aug 2025 09:08:38:483,systemuser,08 Aug 2025 09:08:38:483,,0,0,The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:04:14.717,20250808 09:08:38.483,20250808 09:08:38.483,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Demographics,0/0/V,,What is the protocol date the subject consented to at study start?,SM,16298615,Closed,Mamaking4,07 Oct 2025 10:43:05:017,NadaTruhlarova1,08 Oct 2025 17:34:12:580,Mamaking4,15 Oct 2025 10:54:06:037,,1,7,"Please, correct the date: 17 Mar 2025",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:43:05.017,20251008 17:34:12.580,20251015 10:54:06.037,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15248329,Closed,systemuser,08 Aug 2025 09:18:40:490,systemuser,08 Aug 2025 09:18:50:487,systemuser,08 Aug 2025 09:18:50:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250808 09:18:40.490,20250808 09:18:50.487,20250808 09:18:50.490,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,15526804,Closed,systemuser,22 Aug 2025 11:06:59:657,systemuser,22 Aug 2025 11:15:09:593,systemuser,22 Aug 2025 11:15:09:597,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 11:06:59.657,20250822 11:15:09.593,20250822 11:15:09.597,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15526794,Closed,systemuser,22 Aug 2025 11:06:35:497,systemuser,22 Aug 2025 11:06:59:613,systemuser,22 Aug 2025 11:06:59:617,,0,0,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 11:06:35.497,20250822 11:06:59.613,20250822 11:06:59.617,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15526829,Closed,systemuser,22 Aug 2025 11:07:17:217,systemuser,22 Aug 2025 11:08:11:280,systemuser,22 Aug 2025 11:08:11:280,,0,0,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 11:07:17.217,20250822 11:08:11.280,20250822 11:08:11.280,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15526868,Closed,systemuser,22 Aug 2025 11:08:11:313,systemuser,22 Aug 2025 11:09:02:257,systemuser,22 Aug 2025 11:09:02:260,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 11:08:11.313,20250822 11:09:02.257,20250822 11:09:02.260,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,15526883,Closed,systemuser,22 Aug 2025 11:09:02:293,systemuser,22 Aug 2025 11:12:07:033,systemuser,22 Aug 2025 11:12:07:037,,0,0,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250822 11:09:02.293,20250822 11:12:07.033,20250822 11:12:07.037,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,15691785,Closed,systemuser,28 Aug 2025 09:24:33:793,MartaLendlova1,09 Sep 2025 07:24:18:683,systemuser,12 Sep 2025 07:57:40:113,,12,3,Please enter study drug administration start date as soon as it's available,Will be completed after next on site visit,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 09:24:33.793,20250909 07:24:18.683,20250912 07:57:40.113,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,DM,17016142,Closed,Juhita@ksha4,14 Nov 2025 18:35:31:073,NadaTruhlarova1,16 Nov 2025 16:52:33:520,Juhita@ksha4,18 Nov 2025 07:37:45:250,,2,2,"DM: Please inactivate Log line 2 and 3. If one tablet is consistently taken daily, then only 1 logline should be used with corresponding start and end dates. Other log lines are only needed for missed doses or overdose with start and end dates. Please review completion guideline update the data as appropriate.",Log line 2 and 3 inactivated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 18:35:31.073,20251116 16:52:33.520,20251118 07:37:45.250,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Number of tablets taken,Auto,16363354,Closed,systemuser,10 Oct 2025 21:20:49:240,systemuser,10 Oct 2025 21:21:01:637,systemuser,10 Oct 2025 21:21:01:637,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 21:20:49.240,20251010 21:21:01.637,20251010 21:21:01.637,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,End Date,DM,17789208,Closed,Juhita@ksha4,09 Dec 2025 11:57:00:850,NadaTruhlarova1,12 Dec 2025 21:11:46:270,Juhita@ksha4,15 Dec 2025 07:48:14:287,,3,3,"DM: Please inactivate Log line 2. If one tablet is consistently taken daily, then only 1 logline should be used with corresponding start and end dates. Other log lines are only needed for missed doses or overdose with start and end dates. Please review completion guideline update the data as appropriate.",Log line 2 inactivated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 11:57:00.850,20251212 21:11:46.270,20251215 07:48:14.287,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,16363284,Closed,systemuser,10 Oct 2025 20:49:36:893,,,systemuser,10 Oct 2025 21:20:48:923,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 20:49:36.893,,20251010 21:20:48.923,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Number of tablets taken,Auto,16866179,Closed,systemuser,07 Nov 2025 20:32:03:660,systemuser,07 Nov 2025 20:32:16:133,systemuser,07 Nov 2025 20:32:16:133,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 20:32:03.660,20251107 20:32:16.133,20251107 20:32:16.133,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,End Date,DM,18824427,Closed,Juhita@ksha4,09 Feb 2026 09:03:49:350,NadaTruhlarova1,10 Feb 2026 09:02:10:200,Juhita@ksha4,20 Feb 2026 11:59:44:103,,1,10,DM: Kindly refer the completion guideline and update the end date as appropriate.,Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 09:03:49.350,20260210 09:02:10.200,20260220 11:59:44.103,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,16865941,Closed,systemuser,07 Nov 2025 20:04:10:750,,,systemuser,07 Nov 2025 20:32:03:350,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 20:04:10.750,,20251107 20:32:03.350,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16540875,Closed,systemuser,23 Oct 2025 09:30:37:623,systemuser,23 Oct 2025 09:30:48:730,systemuser,23 Oct 2025 09:30:48:730,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 09:30:37.623,20251023 09:30:48.730,20251023 09:30:48.730,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,17627205,Closed,systemuser,04 Dec 2025 13:23:27:127,systemuser,04 Dec 2025 13:24:04:343,systemuser,04 Dec 2025 13:24:04:343,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:23:27.127,20251204 13:24:04.343,20251204 13:24:04.343,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Pulse,Auto,17627203,Closed,systemuser,04 Dec 2025 13:23:27:103,systemuser,04 Dec 2025 13:24:04:350,systemuser,04 Dec 2025 13:24:04:350,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:23:27.103,20251204 13:24:04.350,20251204 13:24:04.350,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,17627204,Closed,systemuser,04 Dec 2025 13:23:27:113,systemuser,04 Dec 2025 13:24:04:353,systemuser,04 Dec 2025 13:24:04:353,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:23:27.113,20251204 13:24:04.353,20251204 13:24:04.353,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,17627201,Closed,systemuser,04 Dec 2025 13:23:27:077,systemuser,04 Dec 2025 13:24:04:350,systemuser,04 Dec 2025 13:24:04:350,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:23:27.077,20251204 13:24:04.350,20251204 13:24:04.350,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature,Auto,17627202,Closed,systemuser,04 Dec 2025 13:23:27:093,systemuser,04 Dec 2025 13:24:04:350,systemuser,04 Dec 2025 13:24:04:350,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 13:23:27.093,20251204 13:24:04.350,20251204 13:24:04.350,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,16603036,Closed,Ashwini201,27 Oct 2025 13:11:13:783,NadaTruhlarova1,03 Nov 2025 10:00:50:003,Ashwini201,04 Nov 2025 09:13:33:530,,7,1,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Male form, else clarify. ",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 13:11:13.783,20251103 10:00:50.003,20251104 09:13:33.530,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,17020787,Closed,systemuser,16 Nov 2025 16:50:26:727,systemuser,16 Nov 2025 16:51:24:700,systemuser,16 Nov 2025 16:51:24:713,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251116 16:50:26.727,20251116 16:51:24.700,20251116 16:51:24.713,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,17020791,Closed,systemuser,16 Nov 2025 16:50:55:510,systemuser,16 Nov 2025 16:51:24:713,systemuser,16 Nov 2025 16:51:24:713,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251116 16:50:55.510,20251116 16:51:24.713,20251116 16:51:24.713,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,17020793,Closed,systemuser,16 Nov 2025 16:51:41:830,systemuser,16 Nov 2025 16:51:56:710,systemuser,16 Nov 2025 16:51:56:723,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251116 16:51:41.830,20251116 16:51:56.710,20251116 16:51:56.723,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Visit Start Date,Auto,17020794,Closed,systemuser,16 Nov 2025 16:51:41:837,systemuser,16 Nov 2025 16:52:04:510,systemuser,16 Nov 2025 16:52:04:527,,0,0,The date of first study drug administration on the Study Drug Administration is missing. Please update.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251116 16:51:41.837,20251116 16:52:04.510,20251116 16:52:04.527,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15731330,Closed,systemuser,31 Aug 2025 14:17:12:803,systemuser,31 Aug 2025 14:17:19:827,systemuser,31 Aug 2025 14:17:19:837,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250831 14:17:12.803,20250831 14:17:19.827,20250831 14:17:19.837,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,15939175,Closed,systemuser,12 Sep 2025 07:25:12:190,systemuser,12 Sep 2025 07:25:20:603,systemuser,12 Sep 2025 07:25:20:603,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250912 07:25:12.190,20250912 07:25:20.603,20250912 07:25:20.603,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110002,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16154587,Closed,systemuser,25 Sep 2025 14:45:19:750,systemuser,25 Sep 2025 14:45:27:183,systemuser,25 Sep 2025 14:45:27:183,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250925 14:45:19.750,20250925 14:45:27.183,20250925 14:45:27.183,89,335,335,24,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260303 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19234852,Closed,systemuser,02 Mar 2026 13:01:25:563,systemuser,03 Mar 2026 10:02:32:743,systemuser,03 Mar 2026 10:02:32:873,,1,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 13:01:25.563,20260303 10:02:32.743,20260303 10:02:32.873,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936012,Cancelled,systemuser,20 May 2026 13:59:56:820,,,ipanis1,21 May 2026 12:42:14:233,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 13:59:56.820,,20260521 12:42:14.233,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,17646034,Closed,systemuser,05 Dec 2025 08:16:29:850,,,systemuser,05 Dec 2025 10:46:42:007,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:16:29.850,,20251205 10:46:42.007,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17288250,Closed,Ashwini201,25 Nov 2025 14:43:43:427,NadaTruhlarova1,05 Dec 2025 09:10:53:720,shyamaprasad972,08 Dec 2025 12:14:45:387,,10,3," DM: Please verify and update the data on Arizona Sexual Experiences Scale Summary form, else clarify.",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:43:43.427,20251205 09:10:53.720,20251208 12:14:45.387,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,SM,16298618,Closed,Mamaking4,07 Oct 2025 10:43:26:560,NadaTruhlarova1,08 Oct 2025 17:28:45:167,Mamaking4,15 Oct 2025 10:54:15:977,,1,7,"Please, correct the date: 17 Mar 2025",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:43:26.560,20251008 17:28:45.167,20251015 10:54:15.977,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16353597,Closed,Rajani_S_N1,10 Oct 2025 09:36:27:500,NadaTruhlarova1,10 Oct 2025 21:34:10:463,Rajani_S_N1,14 Oct 2025 09:47:12:977,,0,4,"Eligibility: Please elaborate on the clinical findings, and presence of any other  clinical conditions due to FACTOR V LEIDEN (FVL) MUTATION  and on clinical stability ","The subject is stable, no other clinical conditions are known. The subject has been monitored for factor V Leiden mutation for a long time due to a positive family history. ",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 09:36:27.500,20251010 21:34:10.463,20251014 09:47:12.977,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16353620,Closed,Rajani_S_N1,10 Oct 2025 09:38:06:453,NadaTruhlarova1,10 Oct 2025 18:06:49:367,Rajani_S_N1,14 Oct 2025 09:47:12:970,,0,4,Eligibility: Please mention if  subject is on any medications for this condition.,The subject is not taking any medication for this condition.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 09:38:06.453,20251010 18:06:49.367,20251014 09:47:12.970,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,16353671,Closed,Rajani_S_N1,10 Oct 2025 09:41:21:237,NadaTruhlarova1,10 Oct 2025 21:35:14:693,Rajani_S_N1,14 Oct 2025 09:47:12:833,,0,4,Eligibility: Please mention if subject is on any medications for this condition. ,The subject is not receiving any treatment for this condition.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 09:41:21.237,20251010 21:35:14.693,20251014 09:47:12.833,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Current Method(s) of Contraception,Site from Medical Reviewer,16354329,Cancelled,Rajani_S_N1,10 Oct 2025 09:56:13:780,,,Rajani_S_N1,10 Oct 2025 10:03:51:190,,,,Eligibility: Please confirm if the medication is progesterone only,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 09:56:13.780,,20251010 10:03:51.190,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Current Method(s) of Contraception,Site from Medical Reviewer,16354516,Closed,Rajani_S_N1,10 Oct 2025 10:05:23:220,NadaTruhlarova1,10 Oct 2025 18:05:11:247,Rajani_S_N1,14 Oct 2025 09:46:17:657,,0,4,Eligibility: Please confirm if subject is on Progesterone only OCP,The subject uses progesterone OCP and barrier protection.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 10:05:23.220,20251010 18:05:11.247,20251014 09:46:17.657,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",Auto,16186028,Closed,systemuser,28 Sep 2025 14:44:41:370,systemuser,28 Sep 2025 15:22:14:960,systemuser,28 Sep 2025 15:22:14:960,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 14:44:41.370,20250928 15:22:14.960,20250928 15:22:14.960,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,Psychiatric History for Major Depressive Disorder,0/0/N,1,Psychiatric Disorder,Auto,16183965,Closed,systemuser,27 Sep 2025 16:12:01:980,systemuser,27 Sep 2025 16:14:13:940,systemuser,27 Sep 2025 16:14:13:940,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250927 16:12:01.980,20250927 16:14:13.940,20250927 16:14:13.940,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Lifetime Manic Episode,Auto,16185934,Closed,systemuser,28 Sep 2025 13:10:46:257,systemuser,28 Sep 2025 13:12:40:813,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.257,20250928 13:12:40.813,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Lifetime Hypomanic Episode ,Auto,16185935,Closed,systemuser,28 Sep 2025 13:10:46:263,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.263,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,History of Primary psychotic or psychotic depression symptoms (except during past mood episodes),Auto,16185936,Closed,systemuser,28 Sep 2025 13:10:46:270,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.270,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Moderate to severe Alcohol Use Disorder in past 6 months,Auto,16185937,Closed,systemuser,28 Sep 2025 13:10:46:277,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.277,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Moderate to severe Substance Use Disorder (other than nicotine) in past 6 months,Auto,16185938,Closed,systemuser,28 Sep 2025 13:10:46:283,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.283,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Obsessive-Compulsive Disorder in past year,Auto,16185939,Closed,systemuser,28 Sep 2025 13:10:46:290,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.290,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,PTSD in past year,Auto,16185940,Closed,systemuser,28 Sep 2025 13:10:46:297,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.297,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Anorexia Nervosa in past year,Auto,16185941,Closed,systemuser,28 Sep 2025 13:10:46:303,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.303,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Bulimia Nervosa in past year,Auto,16185942,Closed,systemuser,28 Sep 2025 13:10:46:310,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.310,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Panic Disorder past 2 years that was focus of tx,Auto,16185943,Closed,systemuser,28 Sep 2025 13:10:46:317,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.317,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Generalized Anxiety Disorder past 2 years that was focus of tx,Auto,16185944,Closed,systemuser,28 Sep 2025 13:10:46:323,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.323,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Social Anxiety Disorder past 2 years that was focus of tx,Auto,16185945,Closed,systemuser,28 Sep 2025 13:10:46:330,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.330,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Specific Phobia past 2 years that was focus of tx,Auto,16185946,Closed,systemuser,28 Sep 2025 13:10:46:340,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.340,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Symptoms of insomnia in the MDD criteria,Auto,16185933,Closed,systemuser,28 Sep 2025 13:10:46:250,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.250,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Screening Visit 1,SCID-CT,0/0/N,,Current MDE,Auto,16185932,Closed,systemuser,28 Sep 2025 13:10:46:243,systemuser,28 Sep 2025 13:12:40:817,systemuser,28 Sep 2025 13:12:40:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250928 13:10:46.243,20250928 13:12:40.817,20250928 13:12:40.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/N,1,Start Date,Auto,19754635,Closed,systemuser,30 Mar 2026 08:46:46:643,,,systemuser,30 Mar 2026 09:52:42:713,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 08:46:46.643,,20260330 09:52:42.713,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Number of tablets taken,Auto,16540306,Closed,systemuser,23 Oct 2025 09:03:48:293,MartaLendlova1,23 Oct 2025 09:04:21:623,shyamaprasad972,27 Oct 2025 10:51:30:137,,0,4,Required field.  Please complete or provide a response.,Not known at this time,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251023 09:03:48.293,20251023 09:04:21.623,20251027 10:51:30.137,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Number of tablets taken,DM,16597639,Closed,shyamaprasad972,27 Oct 2025 10:54:50:080,MartaLendlova1,27 Oct 2025 15:05:19:720,Ashwini201,17 Nov 2025 13:19:20:333,,0,21,RQ-DM1: Thank you for the response. Please verify and update the data in this field once available.,yes,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 10:54:50.080,20251027 15:05:19.720,20251117 13:19:20.333,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,16519864,Closed,systemuser,22 Oct 2025 08:58:55:180,,,systemuser,23 Oct 2025 09:03:47:910,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:58:55.180,,20251023 09:03:47.910,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,17646033,Closed,systemuser,05 Dec 2025 08:16:29:840,,,systemuser,05 Dec 2025 09:08:08:923,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 08:16:29.840,,20251205 09:08:08.923,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,Start Date,Auto,18694083,Closed,systemuser,30 Jan 2026 08:36:50:343,,,systemuser,01 Feb 2026 07:56:33:710,,,2,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260130 08:36:50.343,,20260201 07:56:33.710,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,18173568,Closed,Ashwini201,23 Dec 2025 07:21:30:090,NadaTruhlarova1,02 Jan 2026 11:25:10:943,Ashwini201,02 Jan 2026 12:04:06:457,,10,0,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify. ",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:21:30.090,20260102 11:25:10.943,20260102 12:04:06.457,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,Drug Testing,0/0/N,,Methamphetamine,DM,18305819,Closed,Juhita@ksha4,06 Jan 2026 06:47:37:563,NadaTruhlarova1,10 Jan 2026 16:38:13:050,Juhita@ksha4,12 Jan 2026 08:54:49:817,,4,2,Medical Review I-1701637: Methamphetamine is positive on Double blind Day 1 visit on site’s urine dipstick result . Kindly note as per CM listing subject is not on amphetamine derivative currently. Kindly clarify if data is accurate. Also clarify if subject is on medication that can account for this result and update CM page accordingly. Please perform a retest and update the results. ,The data was probably entered by mistake as a positive result for methamphetamine.The subject does not use methamphetamine or any drugs that could cause a false positive test result.All other UDS tests performed according to protocol were negative for methamphetamine.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260106 06:47:37.563,20260110 16:38:13.050,20260112 08:54:49.817,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,16530041,Closed,systemuser,22 Oct 2025 17:45:58:310,systemuser,22 Oct 2025 17:46:07:427,systemuser,22 Oct 2025 17:46:07:427,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 17:45:58.310,20251022 17:46:07.427,20251022 17:46:07.427,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/N,,Was the collection date the same as the visit date?,Auto,16519665,Closed,systemuser,22 Oct 2025 08:52:52:537,systemuser,22 Oct 2025 08:53:05:913,systemuser,22 Oct 2025 08:53:05:917,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:52:52.537,20251022 08:53:05.913,20251022 08:53:05.917,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Pulse,Auto,16529724,Closed,systemuser,22 Oct 2025 17:23:31:937,systemuser,23 Oct 2025 09:06:08:067,systemuser,23 Oct 2025 09:06:08:070,,1,0,The 'Pulse' is not within the range of '50' to '100'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 17:23:31.937,20251023 09:06:08.067,20251023 09:06:08.070,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110003,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,16529725,Closed,systemuser,22 Oct 2025 17:23:31:953,systemuser,23 Oct 2025 09:06:08:070,systemuser,23 Oct 2025 09:06:08:070,,1,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 17:23:31.953,20251023 09:06:08.070,20251023 09:06:08.070,89,335,335,18,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,2,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,16353517,Cancelled,systemuser,10 Oct 2025 09:31:21:330,,,systemuser,10 Oct 2025 09:34:05:773,,,,The selected logline has been modified from  '#004 > CONDITION AFTER MENISCUS RUPTURE WITH ARTHROSCOPY' to '#004 > MENISCUS RUPTURE' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251010 09:31:21.330,,20251010 09:34:05.773,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,7,Indication,Auto,16291369,Closed,systemuser,06 Oct 2025 19:30:17:410,NadaTruhlarova1,06 Oct 2025 19:40:04:647,Ashwini201,07 Oct 2025 09:17:37:267,,0,1,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",medication in the previous episode of MDD,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 19:30:17.410,20251006 19:40:04.647,20251007 09:17:37.267,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,8,Indication,Auto,16291558,Closed,systemuser,06 Oct 2025 19:42:14:910,NadaTruhlarova1,06 Oct 2025 19:42:36:023,Ashwini201,07 Oct 2025 09:17:48:450,,0,1,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",medication in the previous episode of MDD,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 19:42:14.910,20251006 19:42:36.023,20251007 09:17:48.450,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,9,Indication,Auto,16291591,Closed,systemuser,06 Oct 2025 19:44:06:760,NadaTruhlarova1,06 Oct 2025 19:44:35:443,Ashwini201,07 Oct 2025 09:17:59:057,,0,1,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",medication in the previous episode of MDD,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 19:44:06.760,20251006 19:44:35.443,20251007 09:17:59.057,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,10,Indication,Auto,16455889,Closed,systemuser,17 Oct 2025 09:37:47:907,systemuser,17 Oct 2025 09:38:23:393,systemuser,17 Oct 2025 09:38:23:397,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:37:47.907,20251017 09:38:23.393,20251017 09:38:23.397,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,10,Indication,Auto,16455961,Closed,systemuser,17 Oct 2025 09:40:31:833,systemuser,17 Oct 2025 09:40:40:427,systemuser,17 Oct 2025 09:40:40:430,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:40:31.833,20251017 09:40:40.427,20251017 09:40:40.430,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,14,Indication,Auto,16456183,Closed,systemuser,17 Oct 2025 09:48:39:097,systemuser,17 Oct 2025 09:48:48:957,systemuser,17 Oct 2025 09:48:48:960,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:48:39.097,20251017 09:48:48.957,20251017 09:48:48.960,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,14,"If Yes, Medication or Therapy",Auto,16456184,Closed,systemuser,17 Oct 2025 09:48:49:230,systemuser,17 Oct 2025 09:48:57:380,systemuser,17 Oct 2025 09:48:57:380,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251017 09:48:49.230,20251017 09:48:57.380,20251017 09:48:57.380,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251027 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,16605853,Closed,systemuser,27 Oct 2025 15:17:14:027,systemuser,27 Oct 2025 15:21:01:873,systemuser,27 Oct 2025 15:21:01:980,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 15:17:14.027,20251027 15:21:01.873,20251027 15:21:01.980,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936048,Cancelled,systemuser,20 May 2026 14:01:36:713,,,ipanis1,21 May 2026 12:42:42:800,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:01:36.713,,20260521 12:42:42.800,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,What was the subject's primary reason for screen failure?,Auto,16605854,Closed,systemuser,27 Oct 2025 15:17:14:080,systemuser,27 Oct 2025 15:19:55:930,systemuser,27 Oct 2025 15:19:55:933,,0,0,"Subject's primary reason for screen failure is 'Failure to Meet Eligibility Criteria', however, ‘Did the subject meet all eligibility criteria?’ is not selected as ‘No’ on the Inclusion/Exclusion Criteria form. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 15:17:14.080,20251027 15:19:55.930,20251027 15:19:55.933,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,16913778,Closed,Juhita@ksha4,11 Nov 2025 09:09:44:113,NadaTruhlarova1,11 Nov 2025 11:25:00:470,Juhita@ksha4,12 Nov 2025 08:42:32:447,,0,1,"ECOA: Trial disposition date is recorded as 17 Oct 2025, however in clinical outcome assessments completion status vendor file collection date is reported as 24 Oct 2025 which is after the trial disposition date. Please verify and update date as appropriate, else clarify.",Date updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251111 09:09:44.113,20251111 11:25:00.470,20251112 08:42:32.447,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,16605979,Closed,systemuser,27 Oct 2025 15:19:56:840,NadaTruhlarova1,03 Nov 2025 10:03:55:893,Ashwini201,04 Nov 2025 09:14:37:540,,7,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",Confirmed in the query answer box. ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251027 15:19:56.840,20251103 10:03:55.893,20251104 09:14:37.540,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,SM,16298623,Closed,Mamaking4,07 Oct 2025 10:43:48:577,NadaTruhlarova1,08 Oct 2025 17:35:02:890,Mamaking4,15 Oct 2025 10:54:35:370,,1,7,"Please, correct the date: 17 Mar 2025",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251007 10:43:48.577,20251008 17:35:02.890,20251015 10:54:35.370,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,General Medical History,0/0/N,3,Is the medical history disease/condition or event still ongoing?,Auto,16284703,Closed,systemuser,06 Oct 2025 11:18:12:010,systemuser,06 Oct 2025 11:20:43:357,systemuser,06 Oct 2025 11:20:43:363,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 11:18:12.010,20251006 11:20:43.357,20251006 11:20:43.363,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Auto,16284702,Closed,systemuser,06 Oct 2025 11:18:11:993,,06 Oct 2025 11:20:43:450,systemuser,06 Oct 2025 11:20:43:450,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 11:18:11.993,20251006 11:20:43.450,20251006 11:20:43.450,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Auto,16284704,Closed,systemuser,06 Oct 2025 11:18:12:023,,06 Oct 2025 11:23:07:957,systemuser,06 Oct 2025 11:23:07:957,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 11:18:12.023,20251006 11:23:07.957,20251006 11:23:07.957,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,DM,16340991,Closed,CoderImport,09 Oct 2025 14:17:19:143,NadaTruhlarova1,10 Oct 2025 09:33:02:693,systemuser,10 Oct 2025 09:33:02:837,,1,0,"""CODING:  Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. MENISCUS RUPTURE and 2.  KNEE ARTHROSCOPY.""",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251009 14:17:19.143,20251010 09:33:02.693,20251010 09:33:02.837,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110004,Screen Failed,Screening Visit 1,General Medical History,0/0/N,4,Is the medical history disease/condition or event still ongoing?,Auto,16284705,Closed,systemuser,06 Oct 2025 11:18:12:040,systemuser,06 Oct 2025 11:23:07:883,systemuser,06 Oct 2025 11:23:07:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251006 11:18:12.040,20251006 11:23:07.883,20251006 11:23:07.890,89,335,335,7,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,,Were any medication(s)/therapy(ies) taken?,Site from Medical Reviewer,17010627,Closed,kavya@1510,14 Nov 2025 12:39:42:260,NadaTruhlarova1,16 Nov 2025 16:47:32:913,kavya@1510,17 Nov 2025 09:20:14:360,,2,1,"Eligibility: Per MSS alert, subject admitted to a single use of a small dose of benzodiazepine from his partner's medication on the evening of November 2, due to anxiety before a study visit and concerns about insomnia. Hence, kindly update the concomitant therapy page with the benzodiazepine details.",Concomitant therapy updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251114 12:39:42.260,20251116 16:47:32.913,20251117 09:20:14.360,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251121 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,17174050,Closed,systemuser,20 Nov 2025 19:53:17:127,systemuser,21 Nov 2025 14:12:26:190,systemuser,21 Nov 2025 14:12:26:313,,1,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251120 19:53:17.127,20251121 14:12:26.190,20251121 14:12:26.313,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936090,Cancelled,systemuser,20 May 2026 14:02:07:723,,,ipanis1,21 May 2026 12:43:11:047,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:02:07.723,,20260521 12:43:11.047,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,17780257,Closed,Juhita@ksha4,09 Dec 2025 09:48:43:267,NadaTruhlarova1,12 Dec 2025 21:08:31:987,Juhita@ksha4,15 Dec 2025 07:46:54:640,,3,3,"ECOA: Trial disposition date is recorded as 20 Nov 2025, however in ECOA vendor file collection date is reported as 21 Nov 2025 which is after the trial disposition date. Please verify and update date as appropriate, else clarify.",Date updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 09:48:43.267,20251212 21:08:31.987,20251215 07:46:54.640,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,17174040,Closed,systemuser,20 Nov 2025 19:52:42:220,NadaTruhlarova1,21 Nov 2025 19:49:16:547,Ashwini201,24 Nov 2025 07:02:55:160,,1,3,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",Confirmed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251120 19:52:42.220,20251121 19:49:16.547,20251124 07:02:55.160,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Site from Medical Reviewer,17045202,Cancelled,kavya@1510,17 Nov 2025 15:28:45:503,,,kavya@1510,18 Nov 2025 07:44:38:607,,,,"Eligibility: Per MSS alert benzodiazepine is positive, any plan for retest/ confirmatory test?",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251117 15:28:45.503,,20251118 07:44:38.607,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Site from Medical Reviewer,17056910,Cancelled,kavya@1510,18 Nov 2025 07:46:27:200,,,kavya@1510,20 Nov 2025 11:36:47:943,,,,"Eligibility: Per MSS alert and confirmatory test, benzodiazepine is reported to be positive. Kindly clarify the reason for reporting the benzodiazepine - negative in EDC",,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 07:46:27.200,,20251120 11:36:47.943,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,1,Assessment Completed?,Auto,17105572,Closed,systemuser,19 Nov 2025 17:06:37:137,systemuser,21 Nov 2025 14:11:31:253,systemuser,21 Nov 2025 14:11:31:253,,2,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251119 17:06:37.137,20251121 14:11:31.253,20251121 14:11:31.253,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110005,Screen Failed,Unscheduled 20251120,Date of Visit,0/0/N,,What is the reason for the unscheduled visit?,Auto,18281822,Closed,systemuser,03 Jan 2026 15:38:11:690,systemuser,03 Jan 2026 15:42:03:947,systemuser,03 Jan 2026 15:42:03:950,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260103 15:38:11.690,20260103 15:42:03.947,20260103 15:42:03.950,89,335,335,8,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,1,Relationship to Study Treatment,DM,19692570,Closed,JThoma858,25 Mar 2026 10:13:00:460,OrsolyaVysztavel1,07 Apr 2026 17:49:10:373,JThoma858,08 Apr 2026 10:06:33:360,,13,1,"Medical Review I-3113587: 1. Kindly clarify rationality to consider AE to be related to study drug.       2.Kindly clarify time of the day when AE occurs, if it is continuous or intermittent and if it affect daily routine activity. ",1. study drug related 2. morning after waking up 3. it occured for one day after first time use,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 10:13:00.460,20260407 17:49:10.373,20260408 10:06:33.360,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/N,2,Start Time,DM,19690677,Closed,JThoma858,25 Mar 2026 09:02:15:580,OrsolyaVysztavel1,07 Apr 2026 17:49:32:340,JThoma858,08 Apr 2026 10:07:12:357,,13,1," Medical Review  I-3113584: Kindly clarify time of the day when AE occurs, if it is continuous or intermittent and if it affect daily routine activity. ",study drug related 2. morning after waking up 3. it occured for one day after first time use,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 09:02:15.580,20260407 17:49:32.340,20260408 10:07:12.357,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Indication,Site from Medical Reviewer,17178367,Closed,Mamatha.K1,21 Nov 2025 04:53:40:237,OrsolyaVysztavel1,21 Nov 2025 20:48:48:493,Mamatha.K1,24 Nov 2025 03:59:14:227,,0,3,Eligibility : Please specify the indication for this medication,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251121 04:53:40.237,20251121 20:48:48.493,20251124 03:59:14.227,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Derived Medication or Therapy for coding purposes(derived field),DM,17775059,Closed,CoderImport,09 Dec 2025 07:14:23:853,OrsolyaVysztavel1,11 Dec 2025 13:04:22:653,systemuser,11 Dec 2025 13:04:23:287,,2,0,"CODING: CODING:  Please update the Indication field to specify the medical condition being treated with this medication instead of "" YAS 0,02MG/3MG"".",amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 07:14:23.853,20251211 13:04:22.653,20251211 13:04:23.287,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Derived Medication or Therapy for coding purposes(derived field),DM,18038256,Closed,CoderImport,17 Dec 2025 05:37:30:260,MartaLendlova1,22 Dec 2025 14:12:26:287,systemuser,22 Dec 2025 14:12:26:837,,5,0,CODING: The reported term OTHER is not a medication. Please specify a medication or if the medication is already captured please inactivate (delete) this term. Thank you.,"This is a contraceptive containing two active ingredients, drospirenone and ethinyl estradiol. I would like to change the field, but unfortunately it is frozen.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251217 05:37:30.260,20251222 14:12:26.287,20251222 14:12:26.837,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,3,Derived Medication or Therapy for coding purposes(derived field),DM,18480474,Closed,CoderImport,16 Jan 2026 11:37:45:687,OrsolyaVysztavel1,20 Jan 2026 10:38:39:950,systemuser,20 Jan 2026 10:38:40:163,,4,0,"RQ1 CODING: Please update the Medication field name to "" drosperinone and ethinyl estradiol"". Thank you.",done,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 11:37:45.687,20260120 10:38:39.950,20260120 10:38:40.163,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260507 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,20453212,Closed,systemuser,28 Apr 2026 09:33:02:873,systemuser,07 May 2026 13:03:29:927,systemuser,07 May 2026 13:03:30:177,,9,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260428 09:33:02.873,20260507 13:03:29.927,20260507 13:03:30.177,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936097,Cancelled,systemuser,20 May 2026 14:02:39:707,,,ipanis1,21 May 2026 12:43:21:767,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:02:39.707,,20260521 12:43:21.767,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,2,Stop date of menstrual period,Auto,18771906,Closed,systemuser,04 Feb 2026 18:24:07:087,,,systemuser,04 Feb 2026 18:24:17:557,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260204 18:24:07.087,,20260204 18:24:17.557,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,2,Stop date of menstrual period,DM,20602145,Closed,Ashwini201,04 May 2026 16:33:19:220,NadaTruhlarova1,07 May 2026 12:59:33:037,Ashwini201,11 May 2026 12:40:37:443,,3,4,"DM: Kindly refer the completion guideline and update the each month data on separate logline, else clarify.",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260504 16:33:19.220,20260507 12:59:33.037,20260511 12:40:37.443,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening to end of study,Menstrual Cycle Tracking Log,0/0/N,6,Start date of menstrual period,DM,20767001,Closed,Ashwini201,11 May 2026 12:41:57:373,NadaTruhlarova1,14 May 2026 06:55:39:257,Ashwini201,14 May 2026 08:42:51:377,,3,0,"DM: Please clarify if the patient had menstrual cycle for the month of Jan 2026. If so, please add a new log line to record that data or else clarify.",Data added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260511 12:41:57.373,20260514 06:55:39.257,20260514 08:42:51.377,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,18339106,Closed,systemuser,07 Jan 2026 19:24:50:670,OrsolyaVysztavel1,13 Jan 2026 15:36:11:013,Ashwini201,14 Jan 2026 10:08:59:327,,6,1,Please enter Yes or No if questionnaire was completed.,"patient is not ending study, she is continuing to part 2",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 19:24:50.670,20260113 15:36:11.013,20260114 10:08:59.327,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,DM,18436458,Closed,Ashwini201,14 Jan 2026 10:09:28:710,OrsolyaVysztavel1,20 Jan 2026 10:39:51:473,Ashwini201,24 Feb 2026 10:13:22:993,,6,35,"RQ-DM1: Thank you for the response. However, visit 8 part 1 was completed on 06-Jan-2026. Kindly update the data as appropriate, else clarify.","the patient is still continuing with part 2, we did not complete screening to end of study",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260114 10:09:28.710,20260120 10:39:51.473,20260224 10:13:22.993,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18136473,Closed,Ashwini201,19 Dec 2025 14:54:59:233,OrsolyaVysztavel1,23 Dec 2025 19:12:51:843,shyamaprasad972,24 Dec 2025 07:37:58:933,,4,1,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 14:54:59.233,20251223 19:12:51.843,20251224 07:37:58.933,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18173623,Closed,Ashwini201,23 Dec 2025 07:26:19:373,OrsolyaVysztavel1,23 Dec 2025 19:13:05:973,Ashwini201,04 Feb 2026 09:52:41:800,,0,43,DM: Please complete the 'Menstrual Cycle Tracking Log' form in 'Screening to end of study' folder.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 07:26:19.373,20251223 19:13:05.973,20260204 09:52:41.800,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18761703 (18173623),Closed,Ashwini201,04 Feb 2026 09:52:42:077,OrsolyaVysztavel1,04 Feb 2026 18:27:56:760,Ashwini201,05 Feb 2026 10:07:55:343,,0,1,"RQ-DM1: Thank you for the response. However, Menstrual Cycle Tracking Log' form in 'Screening to end of study' folder is still not updated. Please update.",amended.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260204 09:52:42.077,20260204 18:27:56.760,20260205 10:07:55.343,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Demographics,0/0/N,,What was the date of the signature on informed consent?,Auto,16829713,Closed,systemuser,06 Nov 2025 11:54:18:867,OrsolyaVysztavel1,06 Nov 2025 15:10:19:277,shyamaprasad972,07 Nov 2025 11:06:24:970,,0,1,Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.,resolved,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 11:54:18.867,20251106 15:10:19.277,20251107 11:06:24.970,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,Auto,16829714,Closed,systemuser,06 Nov 2025 11:54:18:877,OrsolyaVysztavel1,06 Nov 2025 15:10:24:517,shyamaprasad972,07 Nov 2025 11:06:51:117,,0,1,The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.,resolved,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 11:54:18.877,20251106 15:10:24.517,20251107 11:06:51.117,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,DM,16853092,Closed,shyamaprasad972,07 Nov 2025 11:07:53:580,OrsolyaVysztavel1,11 Nov 2025 11:22:42:973,Ashwini201,24 Nov 2025 09:43:25:530,,4,13,RQ-DM1: Thank you for the response. Please review and update the protocol date to reflect the approved version on the site during the consent of this participant.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 11:07:53.580,20251111 11:22:42.973,20251124 09:43:25.530,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,SM,17072818,Closed,Mamaking4,18 Nov 2025 15:02:06:160,NadaTruhlarova1,18 Nov 2025 21:03:01:290,Mamaking4,24 Nov 2025 08:23:19:020,,0,6,"Please, correct the Protocol date: 17 March 2025. Thank you",Corrected.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251118 15:02:06.160,20251118 21:03:01.290,20251124 08:23:19.020,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Is it ongoing?,Auto,16830047,Closed,systemuser,06 Nov 2025 12:07:42:017,systemuser,06 Nov 2025 12:17:54:060,systemuser,06 Nov 2025 12:17:54:060,,0,0,Please enter the response for 'End Date' or 'Is it ongoing'.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 12:07:42.017,20251106 12:17:54.060,20251106 12:17:54.060,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",Auto,16830459,Closed,systemuser,06 Nov 2025 12:19:24:597,OrsolyaVysztavel1,06 Nov 2025 12:20:03:517,shyamaprasad972,07 Nov 2025 11:05:30:847,,0,1,Required field.  Please complete or provide a response.,entry error,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 12:19:24.597,20251106 12:20:03.517,20251107 11:05:30.847,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,"If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term",DM,16852979,Closed,shyamaprasad972,07 Nov 2025 11:05:58:230,OrsolyaVysztavel1,21 Nov 2025 20:52:13:557,Ashwini201,24 Nov 2025 07:03:50:060,,14,3,RQ-DM1: Thank you for the response. Please verify and update the data once available else kindly clarify.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251107 11:05:58.230,20251121 20:52:13.557,20251124 07:03:50.060,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Start Date,Auto,16830046,Closed,systemuser,06 Nov 2025 12:07:41:993,systemuser,06 Nov 2025 12:17:54:053,systemuser,06 Nov 2025 12:17:54:057,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 12:07:41.993,20251106 12:17:54.053,20251106 12:17:54.057,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,2,Start Date,Auto,16835852,Closed,systemuser,06 Nov 2025 15:22:26:600,systemuser,06 Nov 2025 15:22:53:610,systemuser,06 Nov 2025 15:22:53:613,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 15:22:26.600,20251106 15:22:53.610,20251106 15:22:53.613,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,2,Is it ongoing?,Auto,16835853,Closed,systemuser,06 Nov 2025 15:22:26:613,systemuser,06 Nov 2025 15:22:53:617,systemuser,06 Nov 2025 15:22:53:617,,0,0,Please enter the response for 'End Date' or 'Is it ongoing'.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 15:22:26.613,20251106 15:22:53.617,20251106 15:22:53.617,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Neurologic Examination,0/0/N,,Date of Assessment,Auto,18193588,Closed,systemuser,23 Dec 2025 19:11:33:243,systemuser,23 Dec 2025 19:11:49:443,systemuser,23 Dec 2025 19:11:49:443,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 19:11:33.243,20251223 19:11:49.443,20251223 19:11:49.443,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18193577,Closed,systemuser,23 Dec 2025 19:09:57:430,systemuser,23 Dec 2025 19:10:06:123,systemuser,23 Dec 2025 19:10:06:123,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 19:09:57.430,20251223 19:10:06.123,20251223 19:10:06.123,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16829933,Closed,systemuser,06 Nov 2025 12:03:25:500,systemuser,06 Nov 2025 12:03:31:943,systemuser,06 Nov 2025 12:03:31:947,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 12:03:25.500,20251106 12:03:31.943,20251106 12:03:31.947,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Type of Contact,Auto,17241993,Closed,systemuser,24 Nov 2025 14:32:58:013,systemuser,24 Nov 2025 14:33:18:097,systemuser,24 Nov 2025 14:33:18:100,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251124 14:32:58.013,20251124 14:33:18.097,20251124 14:33:18.100,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,17154084,Closed,systemuser,20 Nov 2025 10:32:45:603,,,systemuser,24 Nov 2025 14:32:56:783,,,4,Data entered is in the future. Please correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251120 10:32:45.603,,20251124 14:32:56.783,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,17241992,Closed,systemuser,24 Nov 2025 14:32:57:990,systemuser,24 Nov 2025 14:33:18:720,systemuser,24 Nov 2025 14:33:18:720,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251124 14:32:57.990,20251124 14:33:18.720,20251124 14:33:18.720,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/N,1,Start Date,Auto,19773457,Closed,systemuser,31 Mar 2026 09:48:02:870,,,systemuser,07 Apr 2026 17:40:27:040,,,7,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260331 09:48:02.870,,20260407 17:40:27.040,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/N,1,Start Date,DM,19903728,Closed,JThoma858,10 Apr 2026 07:12:59:783,OrsolyaVysztavel1,24 Apr 2026 19:26:02:027,JThoma858,27 Apr 2026 03:17:43:123,,14,3,DM : Start Date of Part 2 DB Maintenance should align with the same visit as v2.4 (Randomization Date).  Kindly update.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260410 07:12:59.783,20260424 19:26:02.027,20260427 03:17:43.123,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Number of tablets taken,Auto,18161252,Closed,systemuser,22 Dec 2025 14:04:55:320,systemuser,22 Dec 2025 14:06:02:600,systemuser,22 Dec 2025 14:06:02:607,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251222 14:04:55.320,20251222 14:06:02.600,20251222 14:06:02.607,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,17262564,Closed,systemuser,25 Nov 2025 11:13:47:800,,,systemuser,22 Dec 2025 14:04:55:090,,,27,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 11:13:47.800,,20251222 14:04:55.090,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,18339105,Closed,systemuser,07 Jan 2026 19:24:50:660,,,systemuser,13 Jan 2026 15:34:44:837,,,6,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 19:24:50.660,,20260113 15:34:44.837,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,End Date,DM,19656441,Closed,JThoma858,24 Mar 2026 05:44:39:580,OrsolyaVysztavel1,07 Apr 2026 17:44:13:957,JThoma858,08 Apr 2026 07:41:09:163,,14,1,"DM: Please inactivate loglines 2 as the dose was not interrupted. Update the end date of logline 1 .Kindly note &quot;Multiple loglines should only be used when the drug is interrupted; otherwise, a single continuous logline is expected&quot;.","noted, amended",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260324 05:44:39.580,20260407 17:44:13.957,20260408 07:41:09.163,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,End Date,Auto,19854033,Closed,systemuser,07 Apr 2026 17:45:04:783,,,systemuser,07 Apr 2026 17:48:05:107,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 17:45:04.783,,20260407 17:48:05.107,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,Start Date,Auto,18752053,Closed,systemuser,03 Feb 2026 18:11:35:193,,,systemuser,04 Feb 2026 18:30:18:080,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260203 18:11:35.193,,20260204 18:30:18.080,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/N,1,Start Date,DM,19657637,Closed,JThoma858,24 Mar 2026 07:02:49:560,OrsolyaVysztavel1,07 Apr 2026 17:44:22:440,JThoma858,08 Apr 2026 10:08:14:517,,14,1,Medical Review I-3093916:  There is incorrect alignment between drug taken during the induction and stabilization phases. Please review and revise to ensure alignment.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260324 07:02:49.560,20260407 17:44:22.440,20260408 10:08:14.517,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Pulse,Auto,18529202,Closed,systemuser,20 Jan 2026 09:55:58:967,systemuser,20 Jan 2026 09:57:32:830,systemuser,20 Jan 2026 09:57:32:830,,0,0,The 'Pulse' is not within the range of '50' to '100'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 09:55:58.967,20260120 09:57:32.830,20260120 09:57:32.830,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18529201,Closed,systemuser,20 Jan 2026 09:55:58:950,systemuser,20 Jan 2026 09:57:32:830,systemuser,20 Jan 2026 09:57:32:830,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260120 09:55:58.950,20260120 09:57:32.830,20260120 09:57:32.830,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 1.5 Induction (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,18752210,Closed,systemuser,03 Feb 2026 18:28:26:827,systemuser,03 Feb 2026 18:28:37:743,systemuser,03 Feb 2026 18:28:37:747,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260203 18:28:26.827,20260203 18:28:37.743,20260203 18:28:37.747,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 1.5 Induction (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18752091,Closed,systemuser,03 Feb 2026 18:16:47:517,systemuser,03 Feb 2026 18:17:03:983,systemuser,03 Feb 2026 18:17:03:987,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260203 18:16:47.517,20260203 18:17:03.983,20260203 18:17:03.987,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 1.5 Induction (1),Physical Examination,0/0/N,15,Result,Auto,18752092,Closed,systemuser,03 Feb 2026 18:16:47:600,systemuser,03 Feb 2026 18:16:54:353,systemuser,03 Feb 2026 18:16:54:353,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260203 18:16:47.600,20260203 18:16:54.353,20260203 18:16:54.353,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19555574,Closed,systemuser,17 Mar 2026 10:48:26:727,systemuser,17 Mar 2026 10:48:34:423,systemuser,17 Mar 2026 10:48:34:423,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 10:48:26.727,20260317 10:48:34.423,20260317 10:48:34.423,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 2.4 Stabilization,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19853370,Closed,systemuser,07 Apr 2026 16:55:31:890,systemuser,07 Apr 2026 17:54:30:543,systemuser,07 Apr 2026 17:54:30:543,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 16:55:31.890,20260407 17:54:30.543,20260407 17:54:30.543,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,17285467,Closed,systemuser,25 Nov 2025 13:15:09:347,systemuser,11 Dec 2025 13:20:14:693,systemuser,11 Dec 2025 13:20:14:693,,16,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 13:15:09.347,20251211 13:20:14.693,20251211 13:20:14.693,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17277908,Closed,systemuser,25 Nov 2025 12:31:50:847,systemuser,11 Dec 2025 13:20:53:823,systemuser,11 Dec 2025 13:20:53:827,,16,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 12:31:50.847,20251211 13:20:53.823,20251211 13:20:53.827,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,17285226,Closed,systemuser,25 Nov 2025 13:08:32:070,systemuser,25 Nov 2025 13:08:46:377,systemuser,25 Nov 2025 13:08:46:377,,0,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 13:08:32.070,20251125 13:08:46.377,20251125 13:08:46.377,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17285225,Closed,systemuser,25 Nov 2025 13:08:32:057,systemuser,25 Nov 2025 13:08:37:680,systemuser,25 Nov 2025 13:08:37:683,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 13:08:32.057,20251125 13:08:37.680,20251125 13:08:37.683,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 4 Part 1 (1),Date of Visit,0/0/N,,Visit Start Date,Auto,17501649,Closed,systemuser,02 Dec 2025 12:11:42:043,,,systemuser,11 Dec 2025 13:23:02:610,,,9,Date of visit should be greater than the last date of visit. Please reconcile.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251202 12:11:42.043,,20251211 13:23:02.610,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 6 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,17928846,Closed,systemuser,11 Dec 2025 13:09:53:660,systemuser,11 Dec 2025 13:10:06:693,systemuser,11 Dec 2025 13:10:06:693,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251211 13:09:53.660,20251211 13:10:06.693,20251211 13:10:06.693,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Preparatory Acts or Behavior,Auto,17928794,Closed,systemuser,11 Dec 2025 13:07:56:020,systemuser,11 Dec 2025 13:08:59:693,systemuser,11 Dec 2025 13:08:59:693,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251211 13:07:56.020,20251211 13:08:59.693,20251211 13:08:59.693,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/N,,Suicidal Behavior,Auto,17928795,Closed,systemuser,11 Dec 2025 13:07:56:030,systemuser,11 Dec 2025 13:08:59:693,systemuser,11 Dec 2025 13:08:59:693,,0,0,"Suicidcal behavior is marked ""No"" but at least one of the suicidal behavior items above is marked 'Yes'.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251211 13:07:56.030,20251211 13:08:59.693,20251211 13:08:59.693,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Pulse,Auto,18193299,Closed,systemuser,23 Dec 2025 18:40:47:307,systemuser,23 Dec 2025 18:41:08:060,systemuser,23 Dec 2025 18:41:08:060,,0,0,The 'Pulse' is not within the range of '50' to '100'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 18:40:47.307,20251223 18:41:08.060,20251223 18:41:08.060,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18193203,Closed,systemuser,23 Dec 2025 18:36:18:967,systemuser,23 Dec 2025 18:36:35:943,systemuser,23 Dec 2025 18:36:35:947,,0,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 18:36:18.967,20251223 18:36:35.943,20251223 18:36:35.947,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18193204,Closed,systemuser,23 Dec 2025 18:36:18:977,systemuser,23 Dec 2025 18:36:35:963,systemuser,23 Dec 2025 18:36:35:963,,0,0,Systolic blood pressure entered is equal to or less than Diastolic blood pressure. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 18:36:18.977,20251223 18:36:35.963,20251223 18:36:35.963,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18193300,Closed,systemuser,23 Dec 2025 18:40:47:323,systemuser,23 Dec 2025 18:41:08:060,systemuser,23 Dec 2025 18:41:08:060,,0,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 18:40:47.323,20251223 18:41:08.060,20251223 18:41:08.060,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,18339432,Closed,systemuser,07 Jan 2026 19:43:31:913,systemuser,07 Jan 2026 19:43:41:360,systemuser,07 Jan 2026 19:43:41:363,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 19:43:31.913,20260107 19:43:41.360,20260107 19:43:41.363,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110006,Enrolled,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,18339399,Closed,systemuser,07 Jan 2026 19:42:38:243,systemuser,07 Jan 2026 19:42:49:157,systemuser,07 Jan 2026 19:42:49:160,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 19:42:38.243,20260107 19:42:49.157,20260107 19:42:49.160,89,335,335,31,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260428 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,20433266,Closed,systemuser,27 Apr 2026 11:43:58:633,systemuser,28 Apr 2026 09:31:57:103,systemuser,28 Apr 2026 09:31:57:263,,1,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 11:43:58.633,20260428 09:31:57.103,20260428 09:31:57.263,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936107,Cancelled,systemuser,20 May 2026 14:03:12:027,,,ipanis1,21 May 2026 12:43:45:803,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:03:12.027,,20260521 12:43:45.803,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,18477426,Closed,systemuser,16 Jan 2026 10:01:52:197,,,systemuser,16 Jan 2026 10:22:35:190,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 10:01:52.197,,20260116 10:22:35.190,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,18174797,Closed,Ashwini201,23 Dec 2025 08:37:34:383,NadaTruhlarova1,23 Dec 2025 14:28:52:287,shyamaprasad972,24 Dec 2025 07:43:41:847,,0,1,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251223 08:37:34.383,20251223 14:28:52.287,20251224 07:43:41.847,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,17260912,Closed,Rajani_S_N1,25 Nov 2025 10:25:30:083,NadaTruhlarova1,29 Nov 2025 06:36:07:120,Rajani_S_N1,01 Dec 2025 05:51:02:673,,4,2,Eligibility: Kindly mention about the clinical signs and symptoms experienced by the subject and the stability of the medical condition,"The subject is stable, with no clinical symptoms.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 10:25:30.083,20251129 06:36:07.120,20251201 05:51:02.673,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/R,1,Number of tablets taken,Auto,20828359,Closed,systemuser,13 May 2026 17:33:16:790,systemuser,13 May 2026 17:33:52:550,systemuser,13 May 2026 17:33:52:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260513 17:33:16.790,20260513 17:33:52.550,20260513 17:33:52.553,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Maintenance,0/0/R,1,Start Date,Auto,20811514,Closed,systemuser,13 May 2026 07:03:22:020,,,systemuser,13 May 2026 17:33:16:353,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260513 07:03:22.020,,20260513 17:33:16.353,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,17918590,Closed,systemuser,11 Dec 2025 08:19:33:330,,,systemuser,11 Dec 2025 10:37:50:627,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251211 08:19:33.330,,20251211 10:37:50.627,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Number of tablets taken,Auto,18478360,Closed,systemuser,16 Jan 2026 10:39:24:930,systemuser,16 Jan 2026 10:39:37:983,systemuser,16 Jan 2026 10:39:37:983,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 10:39:24.930,20260116 10:39:37.983,20260116 10:39:37.983,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,18477425,Closed,systemuser,16 Jan 2026 10:01:52:183,,,systemuser,16 Jan 2026 10:39:24:037,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260116 10:01:52.183,,20260116 10:39:24.037,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/P,1,Start Date,Auto,19524412,Closed,systemuser,16 Mar 2026 09:09:09:003,,,systemuser,16 Mar 2026 13:39:45:587,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 09:09:09.003,,20260316 13:39:45.587,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Visit 1.4 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the Columbia-Suicide Severity Rating Scale - Since Last Visit completed?,DM,19446781,Closed,JThoma858,10 Mar 2026 14:12:42:050,NadaTruhlarova1,16 Mar 2026 13:39:04:853,JThoma858,17 Mar 2026 05:18:22:223,,6,1,"Medical Review I-2991587: Please confirm if indeed active suicidal ideation (i.e., thoughts of killing self) was indeed present, given supplied text that only suggests death would be a relief. Please revise response in source and EDC if no active SI indeed occurred. If the ideation did occur, please modify stated text and provide clinical judgment as to whether this ideation is CS and merits inclusion as an AE/AESI.&quot;","Text modified. This ideation is NCS, not classified as AE/AESI.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 14:12:42.050,20260316 13:39:04.853,20260317 05:18:22.223,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Pulse,Auto,18972120,Closed,systemuser,16 Feb 2026 10:40:08:623,systemuser,16 Feb 2026 10:40:35:267,systemuser,16 Feb 2026 10:40:35:270,,0,0,The 'Pulse' is not within the range of '50' to '100'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 10:40:08.623,20260216 10:40:35.267,20260216 10:40:35.270,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18972121,Closed,systemuser,16 Feb 2026 10:40:08:650,systemuser,16 Feb 2026 10:40:35:270,systemuser,16 Feb 2026 10:40:35:270,,0,0,The 'Systolic Blood Pressure' is not within the range of '90' to '150'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 10:40:08.650,20260216 10:40:35.270,20260216 10:40:35.270,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110007,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,17969965,Closed,systemuser,12 Dec 2025 22:20:37:777,systemuser,12 Dec 2025 22:20:52:410,systemuser,12 Dec 2025 22:20:52:410,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251212 22:20:37.777,20251212 22:20:52.410,20251212 22:20:52.410,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",Auto,18466237,Closed,systemuser,15 Jan 2026 16:27:55:280,NadaTruhlarova1,15 Jan 2026 16:35:52:900,Ashwini201,16 Jan 2026 07:36:27:373,,0,1,The selected logline has been modified from  '#002 > REFLUX' to '#002 > GASTROESOPHAGEAL REFLUX' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#,confirmed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 16:27:55.280,20260115 16:35:52.900,20260116 07:36:27.373,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/P,6,Indication,Auto,18466324,Closed,systemuser,15 Jan 2026 16:31:45:920,systemuser,15 Jan 2026 16:32:48:440,systemuser,15 Jan 2026 16:32:48:443,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260115 16:31:45.920,20260115 16:32:48.440,20260115 16:32:48.443,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/P,6,Indication,DM,19902283,Closed,JThoma858,10 Apr 2026 06:21:20:097,NadaTruhlarova1,12 Apr 2026 19:36:32:217,JThoma858,13 Apr 2026 07:23:02:013,,2,1,Medical Review I-3113695: Kindly Change indication to Trial Indication-MDD. ,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260410 06:21:20.097,20260412 19:36:32.217,20260413 07:23:02.013,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/P,6,Indication,Auto,19928239,Closed,systemuser,12 Apr 2026 19:36:07:983,NadaTruhlarova1,12 Apr 2026 19:37:27:623,Ashwini201,13 Apr 2026 08:19:21:587,,0,1,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",This is medication for a previous episode of major depressive disorder.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260412 19:36:07.983,20260412 19:37:27.623,20260413 08:19:21.587,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,Indication,DM,19709373,Closed,JThoma858,26 Mar 2026 06:06:53:993,MartaLendlova1,01 Apr 2026 14:43:58:303,JThoma858,02 Apr 2026 05:51:44:433,,6,1,Medical Review I-3113694:  Kindly Change indication to Trial Indication-MDD.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260326 06:06:53.993,20260401 14:43:58.303,20260402 05:51:44.433,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,Indication,Auto,19798189,Closed,systemuser,01 Apr 2026 14:34:04:427,MartaLendlova1,01 Apr 2026 14:44:32:957,Ashwini201,03 Apr 2026 10:25:47:633,,0,2,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",Medication for a previous episode of depression.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260401 14:34:04.427,20260401 14:44:32.957,20260403 10:25:47.633,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936125,Cancelled,systemuser,20 May 2026 14:03:41:340,,,ipanis1,21 May 2026 12:43:54:673,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:03:41.340,,20260521 12:43:54.673,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19461152,Closed,systemuser,11 Mar 2026 09:53:27:887,,,systemuser,11 Mar 2026 09:53:48:717,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260311 09:53:27.887,,20260311 09:53:48.717,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening to end of study,Treatment Disposition - Induction,0/0/R,,Treatment Disposition Date,DM,20785430,Closed,JThoma858,12 May 2026 06:59:43:713,NadaTruhlarova1,12 May 2026 10:02:09:513,JThoma858,13 May 2026 05:13:17:467,,0,1,Medical Review I-11462680: Please complete disposition page.,Completed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260512 06:59:43.713,20260512 10:02:09.513,20260513 05:13:17.467,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,19511051,Closed,Ashwini201,13 Mar 2026 15:15:41:840,NadaTruhlarova1,16 Mar 2026 13:24:08:643,Ashwini201,17 Mar 2026 10:03:01:627,,3,1,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260313 15:15:41.840,20260316 13:24:08.643,20260317 10:03:01.627,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening Visit 1,Demographics,0/0/V,,Sex reported at birth,Auto,18338212,Closed,systemuser,07 Jan 2026 18:12:04:247,systemuser,07 Jan 2026 18:12:26:893,systemuser,07 Jan 2026 18:12:26:907,,0,0,"Sex reported at birth is 'Male. However, What is the subject's childbearing potential? is selected other than 'Not Applicable'. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260107 18:12:04.247,20260107 18:12:26.893,20260107 18:12:26.907,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening Visit 1,General Medical History,0/0/N,2,What is the verbatim term for the medical history condition/event?,DM,18423511,Closed,CoderImport,13 Jan 2026 14:49:44:390,NadaTruhlarova1,15 Jan 2026 16:28:08:857,systemuser,15 Jan 2026 16:28:09:043,,2,0,"CODING: The verbatim ""REFLUX"" appears to be incomplete. Please provide complete diagnosis/condition and update the Medical History field accordingly. Examples: Gastroesophageal reflux, Reflux gastritis, or else specify.",data updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260113 14:49:44.390,20260115 16:28:08.857,20260115 16:28:09.043,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18566919,Cancelled,kavya@1510,21 Jan 2026 19:20:19:017,,,kavya@1510,23 Jan 2026 20:38:34:810,,,,Eligibility: Kindly confirm the underlying cause for cholecystectomy.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260121 19:20:19.017,,20260123 20:38:34.810,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/P,1,End Date,DM,20108918,Closed,Juhita@ksha4,22 Apr 2026 10:27:37:343,NadaTruhlarova1,26 Apr 2026 14:10:41:317,Juhita@ksha4,27 Apr 2026 13:08:03:663,,4,1,Medical Review I-5159336: Please provide end date.,End date updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 10:27:37.343,20260426 14:10:41.317,20260427 13:08:03.663,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/P,1,Start Date,Auto,18629696,Closed,systemuser,27 Jan 2026 08:45:42:383,,,systemuser,27 Jan 2026 16:32:22:123,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260127 08:45:42.383,,20260127 16:32:22.123,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/P,1,End Date,Auto,20828271,Closed,systemuser,13 May 2026 17:24:18:517,systemuser,13 May 2026 17:25:13:623,systemuser,13 May 2026 17:25:13:627,,0,0,"The 'End Date' is after the 'Treatment Disposition Date' (""<core:link text='datapoint.uservalue' formoid='DS_GL_908' folderoid='SCRDS' fieldoid='DSSTDAT_TDD' />"") on the ""<core:link text='Treatment Disposition' formoid='DS_GL_908' folderoid='SCRDS' />"" form. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260513 17:24:18.517,20260513 17:25:13.623,20260513 17:25:13.627,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/P,1,Start Date,Auto,19461151,Closed,systemuser,11 Mar 2026 09:53:27:870,,,systemuser,12 Mar 2026 17:00:31:347,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260311 09:53:27.870,,20260312 17:00:31.347,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Visit 1.7 Induction (1),Date of Visit,1/0/N,,Subject's Status,DM,20911926,Open(R),shyamaprasad972,19 May 2026 11:26:37:217,,,,,2,,,Medical Review I-12758916: Please comment on the clinical significance of higher-than-normal levels of GGT.,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260519 11:26:37.217,,,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,20116502,Closed,Ashwini201,22 Apr 2026 13:34:31:647,NadaTruhlarova1,27 Apr 2026 06:39:24:183,Ashwini201,29 Apr 2026 08:43:57:883,,5,2,"DM: Please verify and update the data on Arizona Sexual Experiences Scale-Male form, else clarify. ",Data updated.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 13:34:31.647,20260427 06:39:24.183,20260429 08:43:57.883,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Severity of illness,Auto,19143512,Closed,systemuser,24 Feb 2026 10:21:13:453,systemuser,24 Feb 2026 10:21:51:713,systemuser,24 Feb 2026 10:21:51:717,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 10:21:13.453,20260224 10:21:51.713,20260224 10:21:51.717,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,Auto,19143510,Closed,systemuser,24 Feb 2026 10:21:13:430,systemuser,24 Feb 2026 10:21:51:730,systemuser,24 Feb 2026 10:21:51:730,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 10:21:13.430,20260224 10:21:51.730,20260224 10:21:51.730,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110008,Enrolled,Visit 7 Part 1 (1),Clinical Global Impression - S (Depression),0/0/V,,"If Yes, was the collection date the same as the visit date?",Auto,19143511,Closed,systemuser,24 Feb 2026 10:21:13:447,systemuser,24 Feb 2026 10:21:51:730,systemuser,24 Feb 2026 10:21:51:730,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260224 10:21:13.447,20260224 10:21:51.730,20260224 10:21:51.730,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,1,What was the individual dose of the medication/therapy?,Auto,18605366,Closed,systemuser,23 Jan 2026 21:18:37:513,systemuser,23 Jan 2026 21:18:49:327,systemuser,23 Jan 2026 21:18:49:330,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260123 21:18:37.513,20260123 21:18:49.327,20260123 21:18:49.330,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,1,End Date,Auto,18727470,Closed,systemuser,02 Feb 2026 18:55:37:593,systemuser,03 Feb 2026 14:01:39:953,systemuser,03 Feb 2026 14:01:39:967,,1,0,"'Ongoing' is Yes, yet an 'End Date' is provided. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 18:55:37.593,20260203 14:01:39.953,20260203 14:01:39.967,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260210 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,18836241,Closed,systemuser,09 Feb 2026 17:50:58:210,systemuser,10 Feb 2026 21:59:41:900,systemuser,10 Feb 2026 21:59:42:003,,1,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:50:58.210,20260210 21:59:41.900,20260210 21:59:42.003,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936208,Cancelled,systemuser,20 May 2026 14:05:11:953,,,ipanis1,21 May 2026 12:44:16:820,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:05:11.953,,20260521 12:44:16.820,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,18944981,Closed,Juhita@ksha4,13 Feb 2026 17:26:33:650,OrsolyaVysztavel1,17 Feb 2026 20:55:02:670,Juhita@ksha4,13 Mar 2026 12:43:23:803,,4,24,"ECOA: Trial disposition date is recorded as 6 Feb 2026, however in ECOA vendor file collection date is reported as 8 Feb 2026 which is after the trial disposition date. Please verify and update date as appropriate, else clarify.",I received the information on screen failure on the 6th,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260213 17:26:33.650,20260217 20:55:02.670,20260313 12:43:23.803,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/N,,Disposition Date,DM,19508334 (18944981),Closed,Juhita@ksha4,13 Mar 2026 12:43:23:957,OrsolyaVysztavel1,17 Mar 2026 10:56:03:813,Juhita@ksha4,13 Apr 2026 13:40:42:800,,4,27,"RQ ECOA1: Thank you for the response, however in clinical outcome assessment vendor file collection date is reported as 8 Feb 2026 which is after the trial disposition date. Please verify and update date as accordingly.",amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260313 12:43:23.957,20260317 10:56:03.813,20260413 13:40:42.800,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/N,,Past 1 Years,Auto,18584381,Closed,systemuser,22 Jan 2026 15:51:04:690,systemuser,22 Jan 2026 16:32:59:753,systemuser,22 Jan 2026 16:32:59:757,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 15:51:04.690,20260122 16:32:59.753,20260122 16:32:59.757,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,18836170,Closed,systemuser,09 Feb 2026 17:42:58:117,,,systemuser,09 Feb 2026 17:43:38:500,,,0,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:42:58.117,,20260209 17:43:38.500,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,18836178,Closed,systemuser,09 Feb 2026 17:43:39:547,systemuser,09 Feb 2026 17:49:07:273,systemuser,09 Feb 2026 17:49:07:273,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:43:39.547,20260209 17:49:07.273,20260209 17:49:07.273,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,18836236,Closed,systemuser,09 Feb 2026 17:49:07:530,OrsolyaVysztavel1,10 Feb 2026 21:57:36:550,shyamaprasad972,11 Feb 2026 08:44:29:557,,1,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.","She would like to continue, and she will be rescreened if she meets the unmet eligiblity criteria in the future. As of now she failed the screening.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:49:07.530,20260210 21:57:36.550,20260211 08:44:29.557,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,19341950,Closed,Ashwini201,06 Mar 2026 12:57:44:047,OrsolyaVysztavel1,20 Mar 2026 11:10:23:003,shyamaprasad972,23 Mar 2026 08:49:12:273,,14,3,DM: Please verify and update the field 'Were any adverse events experienced?' on Adverse event form.,amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:57:44.047,20260320 11:10:23.003,20260323 08:49:12.273,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Demographics,0/0/N,,What was the date of the signature on informed consent?,Auto,18582966,Closed,systemuser,22 Jan 2026 14:41:59:787,systemuser,22 Jan 2026 14:43:19:927,systemuser,22 Jan 2026 14:43:19:930,,0,0,Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 14:41:59.787,20260122 14:43:19.927,20260122 14:43:19.930,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,Auto,18582967,Closed,systemuser,22 Jan 2026 14:41:59:800,systemuser,22 Jan 2026 14:43:19:930,systemuser,22 Jan 2026 14:43:19:930,,0,0,The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 14:41:59.800,20260122 14:43:19.930,20260122 14:43:19.930,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,"If No, enter below information about criteria not satisfied/met (click Add New Log Line to enter more than one criterion)What was the category of the criterion?",Auto,18836162,Closed,systemuser,09 Feb 2026 17:42:58:030,systemuser,09 Feb 2026 17:49:06:230,systemuser,09 Feb 2026 17:49:06:230,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:42:58.030,20260209 17:49:06.230,20260209 17:49:06.230,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,Criterion ID,Auto,18836163,Closed,systemuser,09 Feb 2026 17:42:58:040,systemuser,09 Feb 2026 17:49:06:233,systemuser,09 Feb 2026 17:49:06:233,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:42:58.040,20260209 17:49:06.233,20260209 17:49:06.233,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,"MGH ATRQ, Non-Geriatric, Section I and II",0/0/N,1,"Based on subject's feedback, indicate the amount (%) of improvement in depression he/she reported when they feel it was working at its best.",Auto,18584448,Closed,systemuser,22 Jan 2026 15:55:26:980,systemuser,22 Jan 2026 16:00:45:847,systemuser,22 Jan 2026 16:00:45:850,,0,0,"Took Dose At Least 6 Weeks' and 'Taken during current episode' is checked; however, 'Amount of Improvement' is not selected. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 15:55:26.980,20260122 16:00:45.847,20260122 16:00:45.850,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Psychiatric History for Major Depressive Disorder,0/0/N,,Duration of Current Episode,Auto,18584653,Closed,systemuser,22 Jan 2026 16:22:02:317,systemuser,22 Jan 2026 16:25:56:553,systemuser,22 Jan 2026 16:25:56:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 16:22:02.317,20260122 16:25:56.553,20260122 16:25:56.553,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Stop date,Auto,18836242,Closed,systemuser,09 Feb 2026 17:50:58:230,systemuser,10 Feb 2026 21:59:03:987,systemuser,10 Feb 2026 21:59:03:990,,1,0,"Subject is completed or discontinued. However, stop date is not provided. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 17:50:58.230,20260210 21:59:03.987,20260210 21:59:03.990,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Stop date,Auto,19008540,Closed,systemuser,17 Feb 2026 16:37:01:300,systemuser,17 Feb 2026 16:37:32:457,systemuser,17 Feb 2026 16:37:32:457,,0,0,"Subject is completed or discontinued. However, stop date is not provided. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:37:01.300,20260217 16:37:32.457,20260217 16:37:32.457,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Reason for stopping,Auto,18866169,Closed,systemuser,10 Feb 2026 21:59:04:030,systemuser,17 Feb 2026 16:37:32:463,systemuser,17 Feb 2026 16:37:32:463,,7,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260210 21:59:04.030,20260217 16:37:32.463,20260217 16:37:32.463,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18583978,Closed,systemuser,22 Jan 2026 15:21:58:387,systemuser,22 Jan 2026 16:33:43:707,systemuser,22 Jan 2026 16:33:43:710,,0,0,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 15:21:58.387,20260122 16:33:43.707,20260122 16:33:43.710,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110009,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Temperature,Auto,18583977,Closed,systemuser,22 Jan 2026 15:21:58:367,systemuser,22 Jan 2026 16:33:43:710,systemuser,22 Jan 2026 16:33:43:710,,0,0,The 'Temperature' is not within the range of '35.5' to '37.7' degrees of Celsius. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260122 15:21:58.367,20260122 16:33:43.710,20260122 16:33:43.710,89,335,335,12,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,End Date,Auto,19027347,Closed,systemuser,17 Feb 2026 21:10:07:423,systemuser,17 Feb 2026 21:10:41:863,systemuser,17 Feb 2026 21:10:41:863,,0,0,"'Ongoing' is Yes, yet an 'End Date' is provided. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 21:10:07.423,20260217 21:10:41.863,20260217 21:10:41.863,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936213,Cancelled,systemuser,20 May 2026 14:05:45:293,,,ipanis1,21 May 2026 12:44:40:473,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:05:45.293,,20260521 12:44:40.473,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,20083598,Closed,systemuser,21 Apr 2026 13:02:24:600,,,systemuser,24 Apr 2026 19:27:05:647,,,3,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:02:24.600,,20260424 19:27:05.647,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Alcohol Test,0/0/N,,Alcohol Test Result,Auto,19007381,Closed,systemuser,17 Feb 2026 16:19:30:160,systemuser,17 Feb 2026 16:19:40:213,systemuser,17 Feb 2026 16:19:40:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:19:30.160,20260217 16:19:40.213,20260217 16:19:40.213,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Alcohol Test,0/0/N,,Collection Date,Auto,19007380,Closed,systemuser,17 Feb 2026 16:19:30:150,systemuser,17 Feb 2026 16:19:40:213,systemuser,17 Feb 2026 16:19:40:213,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:19:30.150,20260217 16:19:40.213,20260217 16:19:40.213,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,19523589,Closed,Ashwini201,16 Mar 2026 08:24:18:453,OrsolyaVysztavel1,20 Mar 2026 11:08:35:143,shyamaprasad972,23 Mar 2026 08:31:59:417,,4,3,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 08:24:18.453,20260320 11:08:35.143,20260323 08:31:59.417,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the subject's childbearing potential?,Site from Medical Reviewer,19239208,Closed,Rajani_S_N1,02 Mar 2026 16:22:20:283,OrsolyaVysztavel1,03 Mar 2026 11:40:05:897,Rajani_S_N1,03 Mar 2026 12:32:33:423,,1,0,Eligibility: Kindly confirm if subject will use highly effective method of contraception with partner  and agree to  not donate sperm during study and for 3 months after the last dose of IP,"Yes, he agreed to these terms.",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 16:22:20.283,20260303 11:40:05.897,20260303 12:32:33.423,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the subject's childbearing potential?,Site from Medical Reviewer,19239211,Cancelled,Rajani_S_N1,02 Mar 2026 16:23:03:327,,,Rajani_S_N1,02 Mar 2026 16:23:07:590,,,,Eligibility: Kindly confirm if subject can adhere to highly effective method of contraception with partner and agree to not donate sperm during study and for 3 months after the last dose of IP ,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260302 16:23:03.327,,20260302 16:23:07.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,What was the date of the signature on informed consent?,Auto,20648593,Closed,systemuser,06 May 2026 13:32:35:007,systemuser,06 May 2026 13:35:29:930,systemuser,06 May 2026 13:35:29:930,,0,0,Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 13:32:35.007,20260506 13:35:29.930,20260506 13:35:29.930,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,Sex reported at birth,Auto,19007328,Closed,systemuser,17 Feb 2026 16:15:29:177,systemuser,17 Feb 2026 16:15:48:593,systemuser,17 Feb 2026 16:15:48:610,,0,0,"Sex reported at birth is 'Male. However, What is the subject's childbearing potential? is selected other than 'Not Applicable'. Please review.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:15:29.177,20260217 16:15:48.593,20260217 16:15:48.610,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,DM,20612521,Closed,SanchariDutta@025,05 May 2026 11:05:09:413,MartaLendlova1,06 May 2026 13:36:08:540,SanchariDutta@025,06 May 2026 13:55:38:810,,1,0,DM: Please review and update the protocol date to reflect the approved version on the site during the consent of this participant. ,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260505 11:05:09.413,20260506 13:36:08.540,20260506 13:55:38.810,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Demographics,0/0/N,,What is the protocol date the subject consented to at study start?,Auto,20648594,Closed,systemuser,06 May 2026 13:32:35:027,MartaLendlova1,06 May 2026 13:33:31:133,Ashwini201,07 May 2026 07:54:07:753,,0,1,The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260506 13:32:35.027,20260506 13:33:31.133,20260507 07:54:07.753,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,19007363,Closed,systemuser,17 Feb 2026 16:18:35:147,systemuser,17 Feb 2026 16:19:18:903,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.147,20260217 16:19:18.903,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,19007364,Closed,systemuser,17 Feb 2026 16:18:35:203,systemuser,17 Feb 2026 16:19:18:907,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.203,20260217 16:19:18.907,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,19007365,Closed,systemuser,17 Feb 2026 16:18:35:250,systemuser,17 Feb 2026 16:19:18:907,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.250,20260217 16:19:18.907,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,19007366,Closed,systemuser,17 Feb 2026 16:18:35:323,systemuser,17 Feb 2026 16:19:18:907,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.323,20260217 16:19:18.907,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,19007367,Closed,systemuser,17 Feb 2026 16:18:35:360,systemuser,17 Feb 2026 16:19:18:907,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.360,20260217 16:19:18.907,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Collection Time,Auto,19007362,Closed,systemuser,17 Feb 2026 16:18:35:077,systemuser,17 Feb 2026 16:19:18:937,systemuser,17 Feb 2026 16:19:18:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.077,20260217 16:19:18.937,20260217 16:19:18.937,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,19007368,Closed,systemuser,17 Feb 2026 16:18:35:403,systemuser,17 Feb 2026 16:19:18:937,systemuser,17 Feb 2026 16:19:18:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.403,20260217 16:19:18.937,20260217 16:19:18.937,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,19007370,Closed,systemuser,17 Feb 2026 16:18:35:490,systemuser,17 Feb 2026 16:19:18:937,systemuser,17 Feb 2026 16:19:18:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.490,20260217 16:19:18.937,20260217 16:19:18.937,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,19007369,Closed,systemuser,17 Feb 2026 16:18:35:447,systemuser,17 Feb 2026 16:19:18:937,systemuser,17 Feb 2026 16:19:18:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.447,20260217 16:19:18.937,20260217 16:19:18.937,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,19007371,Closed,systemuser,17 Feb 2026 16:18:35:523,systemuser,17 Feb 2026 16:19:18:937,systemuser,17 Feb 2026 16:19:18:937,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:35.523,20260217 16:19:18.937,20260217 16:19:18.937,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,19007361,Closed,systemuser,17 Feb 2026 16:18:34:997,systemuser,17 Feb 2026 16:19:18:907,systemuser,17 Feb 2026 16:19:18:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:34.997,20260217 16:19:18.907,20260217 16:19:18.907,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Neurologic Examination,0/0/N,,Date of Assessment,Auto,19618810,Closed,systemuser,20 Mar 2026 11:06:25:573,systemuser,20 Mar 2026 11:06:54:060,systemuser,20 Mar 2026 11:06:54:063,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260320 11:06:25.573,20260320 11:06:54.060,20260320 11:06:54.063,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19007360,Closed,systemuser,17 Feb 2026 16:18:04:077,systemuser,17 Feb 2026 16:18:25:763,systemuser,17 Feb 2026 16:18:25:767,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 16:18:04.077,20260217 16:18:25.763,20260217 16:18:25.767,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Screening Visit 2 (1),Date of Visit,0/0/N,,Subject's Status,Auto,19297774,Closed,systemuser,04 Mar 2026 09:44:27:857,systemuser,04 Mar 2026 09:45:16:020,systemuser,04 Mar 2026 09:45:16:027,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260304 09:44:27.857,20260304 09:45:16.020,20260304 09:45:16.027,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/N,1,Start Date,Auto,19440636,Closed,systemuser,10 Mar 2026 10:39:26:183,,,systemuser,20 Mar 2026 11:09:17:737,,,10,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 10:39:26.183,,20260320 11:09:17.737,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/N,1,Start Date,Auto,20083597,Closed,systemuser,21 Apr 2026 13:02:24:570,,,systemuser,21 Apr 2026 13:20:12:047,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:02:24.570,,20260421 13:20:12.047,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,1/0/R,1,Start Date,Auto,20908883,Open(R),systemuser,19 May 2026 09:28:33:810,,,,,2,,,Please enter study drug administration start date as soon as it's available,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260519 09:28:33.810,,,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 1.5 Induction (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,20922619,Closed,systemuser,19 May 2026 22:01:35:713,systemuser,19 May 2026 22:01:46:137,systemuser,19 May 2026 22:01:46:140,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260519 22:01:35.713,20260519 22:01:46.137,20260519 22:01:46.140,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 3 Part 1 Baseline,Date of Visit,0/0/N,,Did this visit occur?,DM,19635940,Closed,Ashwini201,23 Mar 2026 08:28:09:143,OrsolyaVysztavel1,30 Mar 2026 19:00:14:103,shyamaprasad972,01 Apr 2026 10:42:34:507,,7,2,"DM: Please verify and update the data on all blank forms of Visit 3 Part 1 Baseline, else clarify.",amended,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260323 08:28:09.143,20260330 19:00:14.103,20260401 10:42:34.507,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/N,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,19440536,Closed,systemuser,10 Mar 2026 10:35:38:377,systemuser,10 Mar 2026 10:35:48:440,systemuser,10 Mar 2026 10:35:48:440,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 10:35:38.377,20260310 10:35:48.440,20260310 10:35:48.440,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,19764709,Closed,systemuser,30 Mar 2026 18:37:50:273,systemuser,30 Mar 2026 18:37:59:093,systemuser,30 Mar 2026 18:37:59:093,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260330 18:37:50.273,20260330 18:37:59.093,20260330 18:37:59.093,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19737002,Closed,systemuser,27 Mar 2026 07:56:38:847,systemuser,27 Mar 2026 07:56:44:127,systemuser,27 Mar 2026 07:56:44:127,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260327 07:56:38.847,20260327 07:56:44.127,20260327 07:56:44.127,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19854114,Closed,systemuser,07 Apr 2026 17:55:41:060,systemuser,07 Apr 2026 18:34:44:407,systemuser,07 Apr 2026 18:34:44:410,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260407 17:55:41.060,20260407 18:34:44.407,20260407 18:34:44.410,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Severity of illness,Auto,20085593,Closed,systemuser,21 Apr 2026 13:51:21:600,systemuser,24 Apr 2026 19:27:27:200,systemuser,24 Apr 2026 19:27:27:200,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:51:21.600,20260424 19:27:27.200,20260424 19:27:27.200,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Clinical Global Impression - S (Depression),0/0/N,,Rater's Initials,Auto,20085592,Closed,systemuser,21 Apr 2026 13:51:21:583,systemuser,24 Apr 2026 19:27:27:227,systemuser,24 Apr 2026 19:27:27:227,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:51:21.583,20260424 19:27:27.227,20260424 19:27:27.227,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,20083961,Closed,systemuser,21 Apr 2026 13:11:49:080,systemuser,21 Apr 2026 13:14:05:587,systemuser,21 Apr 2026 13:14:05:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.080,20260421 13:14:05.587,20260421 13:14:05.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,20083962,Closed,systemuser,21 Apr 2026 13:11:49:090,systemuser,21 Apr 2026 13:14:05:590,systemuser,21 Apr 2026 13:14:05:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.090,20260421 13:14:05.590,20260421 13:14:05.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,20083963,Closed,systemuser,21 Apr 2026 13:11:49:097,systemuser,21 Apr 2026 13:14:05:590,systemuser,21 Apr 2026 13:14:05:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.097,20260421 13:14:05.590,20260421 13:14:05.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,20083964,Closed,systemuser,21 Apr 2026 13:11:49:103,systemuser,21 Apr 2026 13:14:05:590,systemuser,21 Apr 2026 13:14:05:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.103,20260421 13:14:05.590,20260421 13:14:05.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,20083965,Closed,systemuser,21 Apr 2026 13:11:49:117,systemuser,21 Apr 2026 13:14:05:590,systemuser,21 Apr 2026 13:14:05:590,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.117,20260421 13:14:05.590,20260421 13:14:05.590,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,20083960,Closed,systemuser,21 Apr 2026 13:11:49:067,systemuser,21 Apr 2026 13:14:05:620,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.067,20260421 13:14:05.620,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,20083966,Closed,systemuser,21 Apr 2026 13:11:49:123,systemuser,21 Apr 2026 13:14:05:623,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.123,20260421 13:14:05.623,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,20083968,Closed,systemuser,21 Apr 2026 13:11:49:147,systemuser,21 Apr 2026 13:14:05:623,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.147,20260421 13:14:05.623,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,20083967,Closed,systemuser,21 Apr 2026 13:11:49:137,systemuser,21 Apr 2026 13:14:05:623,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.137,20260421 13:14:05.623,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,20083969,Closed,systemuser,21 Apr 2026 13:11:49:177,systemuser,21 Apr 2026 13:14:05:623,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:49.177,20260421 13:14:05.623,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,20083959,Closed,systemuser,21 Apr 2026 13:11:48:823,systemuser,21 Apr 2026 13:14:05:623,systemuser,21 Apr 2026 13:14:05:623,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:11:48.823,20260421 13:14:05.623,20260421 13:14:05.623,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),EQ-5D-5L,0/0/N,,Your health today,Auto,20085812,Closed,systemuser,21 Apr 2026 13:53:27:183,systemuser,27 Apr 2026 06:57:17:140,systemuser,27 Apr 2026 06:57:17:143,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:53:27.183,20260427 06:57:17.140,20260427 06:57:17.143,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started the study medication, how are your depression symptoms?",Auto,20083678,Closed,systemuser,21 Apr 2026 13:03:22:993,systemuser,27 Apr 2026 06:54:07:937,systemuser,27 Apr 2026 06:54:07:940,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:03:22.993,20260427 06:54:07.937,20260427 06:54:07.940,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your difficulty falling asleep or staying asleep?",Auto,20083679,Closed,systemuser,21 Apr 2026 13:03:23:000,systemuser,27 Apr 2026 06:54:07:940,systemuser,27 Apr 2026 06:54:07:940,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:03:23.000,20260427 06:54:07.940,20260427 06:54:07.940,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your experience of not feeling rested the next day?",Auto,20083680,Closed,systemuser,21 Apr 2026 13:03:23:007,systemuser,27 Apr 2026 06:54:07:940,systemuser,27 Apr 2026 06:54:07:940,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:03:23.007,20260427 06:54:07.940,20260427 06:54:07.940,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Change - Depression/Insomnia,0/0/N,,"Compared to when you started this study, how would you describe your sleep problems?",Auto,20083681,Closed,systemuser,21 Apr 2026 13:03:23:020,systemuser,27 Apr 2026 06:54:07:940,systemuser,27 Apr 2026 06:54:07:940,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:03:23.020,20260427 06:54:07.940,20260427 06:54:07.940,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.",Auto,20086095,Closed,systemuser,21 Apr 2026 13:58:39:600,systemuser,27 Apr 2026 06:54:54:370,systemuser,27 Apr 2026 06:54:54:370,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:58:39.600,20260427 06:54:54.370,20260427 06:54:54.370,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.",Auto,20086094,Closed,systemuser,21 Apr 2026 13:58:39:587,systemuser,27 Apr 2026 06:54:54:370,systemuser,27 Apr 2026 06:54:54:373,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:58:39.587,20260427 06:54:54.370,20260427 06:54:54.373,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Global Impression of Severity - Insomnia,0/0/N,,"In the past 7 days, how would you describe your sleep problems?",Auto,20086096,Closed,systemuser,21 Apr 2026 13:58:39:610,systemuser,27 Apr 2026 06:54:54:373,systemuser,27 Apr 2026 06:54:54:373,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:58:39.610,20260427 06:54:54.373,20260427 06:54:54.373,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Patient Health Questionnaire - 9 Item,0/0/N,,5. Poor appetite or overeating.,Auto,20084879,Closed,systemuser,21 Apr 2026 13:36:10:167,systemuser,27 Apr 2026 06:56:00:977,systemuser,27 Apr 2026 06:56:00:980,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:36:10.167,20260427 06:56:00.977,20260427 06:56:00.980,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,2. Apparent Sadness,Auto,20085460,Closed,systemuser,21 Apr 2026 13:50:28:727,systemuser,27 Apr 2026 06:51:39:160,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.727,20260427 06:51:39.160,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,3. Inner Tension,Auto,20085461,Closed,systemuser,21 Apr 2026 13:50:28:740,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.740,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,4. Reduced Sleep,Auto,20085462,Closed,systemuser,21 Apr 2026 13:50:28:763,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.763,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,5. Reduced Appetite,Auto,20085463,Closed,systemuser,21 Apr 2026 13:50:28:783,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.783,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,6. Concentration Difficulties,Auto,20085464,Closed,systemuser,21 Apr 2026 13:50:28:807,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.807,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,7. Lassitude,Auto,20085465,Closed,systemuser,21 Apr 2026 13:50:28:827,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.827,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,8. Inability to Feel,Auto,20085466,Closed,systemuser,21 Apr 2026 13:50:28:843,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.843,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,9. Pessimistic Thoughts,Auto,20085467,Closed,systemuser,21 Apr 2026 13:50:28:867,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.867,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,10. Suicidal Thoughts,Auto,20085468,Closed,systemuser,21 Apr 2026 13:50:28:897,systemuser,27 Apr 2026 06:51:39:163,systemuser,27 Apr 2026 06:51:39:163,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.897,20260427 06:51:39.163,20260427 06:51:39.163,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,TOTAL MADRS SCALE SCORE,Auto,20085469,Closed,systemuser,21 Apr 2026 13:50:28:917,systemuser,27 Apr 2026 06:51:39:570,systemuser,27 Apr 2026 06:51:39:570,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.917,20260427 06:51:39.570,20260427 06:51:39.570,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/N,,Rater's Initials,Auto,20085459,Closed,systemuser,21 Apr 2026 13:50:28:703,systemuser,27 Apr 2026 06:51:39:187,systemuser,27 Apr 2026 06:51:39:187,,6,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:50:28.703,20260427 06:51:39.187,20260427 06:51:39.187,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110010,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20084117,Closed,systemuser,21 Apr 2026 13:15:19:193,systemuser,21 Apr 2026 13:15:45:607,systemuser,21 Apr 2026 13:15:45:607,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260421 13:15:19.193,20260421 13:15:45.607,20260421 13:15:45.607,89,335,335,27,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260316 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19526743,Closed,systemuser,16 Mar 2026 10:27:02:583,systemuser,16 Mar 2026 10:27:15:990,systemuser,16 Mar 2026 10:27:16:127,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:27:02.583,20260316 10:27:15.990,20260316 10:27:16.127,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936217,Cancelled,systemuser,20 May 2026 14:06:16:250,,,ipanis1,21 May 2026 12:44:58:967,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:06:16.250,,20260521 12:44:58.967,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,19526696,Closed,systemuser,16 Mar 2026 10:23:56:103,NadaTruhlarova1,16 Mar 2026 13:15:57:100,Ashwini201,17 Mar 2026 10:04:19:323,,0,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",Confirmed. ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:23:56.103,20260316 13:15:57.100,20260317 10:04:19.323,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,"If No, enter below information about criteria not satisfied/met (click Add New Log Line to enter more than one criterion)What was the category of the criterion?",Auto,19526688,Closed,systemuser,16 Mar 2026 10:23:56:017,systemuser,16 Mar 2026 10:24:58:607,systemuser,16 Mar 2026 10:24:58:613,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:23:56.017,20260316 10:24:58.607,20260316 10:24:58.613,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,Criterion ID,Auto,19526689,Closed,systemuser,16 Mar 2026 10:23:56:030,systemuser,16 Mar 2026 10:24:58:613,systemuser,16 Mar 2026 10:24:58:613,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:23:56.030,20260316 10:24:58.613,20260316 10:24:58.613,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110011,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,19257299,Closed,systemuser,03 Mar 2026 11:17:44:493,systemuser,03 Mar 2026 11:18:14:083,systemuser,03 Mar 2026 11:18:14:087,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260303 11:17:44.493,20260303 11:18:14.083,20260303 11:18:14.087,89,335,335,5,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110012,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260316 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19526777,Closed,systemuser,16 Mar 2026 10:28:23:380,systemuser,16 Mar 2026 10:28:37:173,systemuser,16 Mar 2026 10:28:37:297,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:28:23.380,20260316 10:28:37.173,20260316 10:28:37.297,89,335,335,3,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110012,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260520 - PART1 - Interim Investigator Signature,0/0/N,,I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.,Auto,20936243,Cancelled,systemuser,20 May 2026 14:06:44:987,,,ipanis1,21 May 2026 12:45:06:970,,,,Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).,,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 14:06:44.987,,20260521 12:45:06.970,89,335,335,3,185,713,713
CZE,S10-CZ10011,MEDIPA s r o,CZ100110012,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,19526771,Closed,systemuser,16 Mar 2026 10:28:02:883,NadaTruhlarova1,16 Mar 2026 13:16:15:723,Ashwini201,17 Mar 2026 10:05:08:847,,0,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",Confirmed. ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260316 10:28:02.883,20260316 13:16:15.723,20260317 10:05:08.847,89,335,335,3,185,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,1,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,15368495,Closed,systemuser,18 Aug 2025 09:24:39:277,systemuser,18 Aug 2025 09:24:56:950,systemuser,18 Aug 2025 09:24:56:953,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250818 09:24:39.277,20250818 09:24:56.950,20250818 09:24:56.953,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,Derived Medication or Therapy for coding purposes(derived field),DM,15808098,Closed,CoderImport,04 Sep 2025 07:21:56:583,MSedlackova11,05 Sep 2025 12:28:28:117,systemuser,05 Sep 2025 12:28:28:237,,1,0,"CODING: The reported term ""SPIROMAX"" is too general for coding purpose. Please specify the exact trade name or the active ingredients that was administered in the medication field. Example: DUORESP SPIROMAX, Others.",corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 07:21:56.583,20250905 12:28:28.117,20250905 12:28:28.237,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20250905 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,15661715,Closed,systemuser,28 Aug 2025 08:56:46:780,systemuser,05 Sep 2025 12:32:31:413,systemuser,05 Sep 2025 12:32:31:543,,8,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 08:56:46.780,20250905 12:32:31.413,20250905 12:32:31.543,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,15661471,Closed,systemuser,28 Aug 2025 08:42:48:083,MSedlackova11,03 Sep 2025 13:16:42:430,shyamaprasad972,04 Sep 2025 07:06:44:813,,6,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.","confirm, subject was SF after independente raters call",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 08:42:48.083,20250903 13:16:42.430,20250904 07:06:44.813,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,DM,16215936,Closed,Ashwini201,30 Sep 2025 15:27:39:237,MSedlackova11,01 Oct 2025 12:52:27:380,Ashwini201,01 Oct 2025 14:36:16:640,,1,0,DM: Please verify and update the field 'Were any adverse events experienced?' on Adverse event form.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250930 15:27:39.237,20251001 12:52:27.380,20251001 14:36:16.640,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,Criterion ID,Auto,15661464,Closed,systemuser,28 Aug 2025 08:42:47:890,systemuser,28 Aug 2025 08:54:16:037,systemuser,28 Aug 2025 08:54:16:040,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250828 08:42:47.890,20250828 08:54:16.037,20250828 08:54:16.040,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120001,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Body Mass Index,Auto,15191548,Closed,systemuser,06 Aug 2025 14:27:01:310,systemuser,06 Aug 2025 14:27:50:237,systemuser,06 Aug 2025 14:27:50:240,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250806 14:27:01.310,20250806 14:27:50.237,20250806 14:27:50.240,48,335,335,5,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,2,Start Date,Auto,15818862,Closed,systemuser,04 Sep 2025 14:31:01:620,,,systemuser,04 Sep 2025 14:31:54:280,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 14:31:01.620,,20250904 14:31:54.280,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,Start Date,Auto,15818915,Closed,systemuser,04 Sep 2025 14:33:55:290,systemuser,05 Sep 2025 12:26:26:440,systemuser,05 Sep 2025 12:26:26:443,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 14:33:55.290,20250905 12:26:26.440,20250905 12:26:26.443,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,4,What was the individual dose of the medication/therapy?,Auto,15818914,Closed,systemuser,04 Sep 2025 14:33:55:250,systemuser,05 Sep 2025 12:26:26:150,systemuser,05 Sep 2025 12:26:26:163,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 14:33:55.250,20250905 12:26:26.150,20250905 12:26:26.163,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,What was the individual dose of the medication/therapy?,Auto,16142857,Closed,systemuser,25 Sep 2025 07:48:04:790,,,systemuser,25 Sep 2025 07:48:31:863,,,0,Dose contains a space or a comma or a non-numeric character; Please correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250925 07:48:04.790,,20250925 07:48:31.863,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/N,5,What was the individual dose of the medication/therapy?,Auto,16142866,Closed,systemuser,25 Sep 2025 07:48:32:263,systemuser,25 Sep 2025 07:48:43:557,systemuser,25 Sep 2025 07:48:43:560,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250925 07:48:32.263,20250925 07:48:43.557,20250925 07:48:43.560,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251015 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,16229433,Closed,systemuser,01 Oct 2025 12:54:02:347,systemuser,15 Oct 2025 14:06:04:623,systemuser,15 Oct 2025 14:06:04:733,,14,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 12:54:02.347,20251015 14:06:04.623,20251015 14:06:04.733,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,16229429,Closed,systemuser,01 Oct 2025 12:53:30:003,MSedlackova11,01 Oct 2025 12:54:39:983,Ashwini201,03 Oct 2025 07:37:09:820,,0,2,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",patient is SF,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 12:53:30.003,20251001 12:54:39.983,20251003 07:37:09.820,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,Menstrual Cycle Tracking,0/0/N,1,Start Date,Auto,15787073,Closed,systemuser,03 Sep 2025 14:11:37:100,systemuser,03 Sep 2025 14:14:02:840,systemuser,03 Sep 2025 14:14:02:840,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250903 14:11:37.100,20250903 14:14:02.840,20250903 14:14:02.840,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,"MGH ATRQ, Non-Geriatric, Section I and II",0/0/N,3,"Based on subject's feedback, indicate the amount (%) of improvement in depression he/she reported when they feel it was working at its best.",Auto,15818769,Closed,systemuser,04 Sep 2025 14:26:39:777,systemuser,04 Sep 2025 14:26:55:807,systemuser,04 Sep 2025 14:26:55:807,,0,0,"Took Dose At Least 6 Weeks' and 'Taken during current episode' is checked; however, 'Amount of Improvement' is not selected. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250904 14:26:39.777,20250904 14:26:55.807,20250904 14:26:55.807,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Stop date,Auto,15786067,Closed,systemuser,03 Sep 2025 14:07:42:283,,,systemuser,03 Sep 2025 14:14:39:260,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250903 14:07:42.283,,20250903 14:14:39.260,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Start date,Auto,15786066,Closed,systemuser,03 Sep 2025 14:07:42:253,,,systemuser,03 Sep 2025 14:14:39:270,,,0,Data is not in the expected format.  Please Correct.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20250903 14:07:42.253,,20250903 14:14:39.270,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120002,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,2,Stop date,Auto,16229434,Closed,systemuser,01 Oct 2025 12:54:02:367,MSedlackova11,01 Oct 2025 12:55:07:607,Ashwini201,03 Oct 2025 07:36:59:500,,0,2,"Subject is completed or discontinued. However, stop date is not provided. Please review.",is ongoing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 12:54:02.367,20251001 12:55:07.607,20251003 07:36:59.500,48,335,335,6,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20251124 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,16834811,Closed,systemuser,06 Nov 2025 14:33:17:833,systemuser,24 Nov 2025 08:04:11:713,systemuser,24 Nov 2025 08:04:11:830,,18,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:33:17.833,20251124 08:04:11.713,20251124 08:04:11.830,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231790,Closed,systemuser,01 Oct 2025 14:16:21:640,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.640,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231791,Closed,systemuser,01 Oct 2025 14:16:21:653,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.653,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231792,Closed,systemuser,01 Oct 2025 14:16:21:660,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.660,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231793,Closed,systemuser,01 Oct 2025 14:16:21:667,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.667,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231794,Closed,systemuser,01 Oct 2025 14:16:21:670,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.670,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,Past 6 Months,Auto,16231795,Closed,systemuser,01 Oct 2025 14:16:21:677,systemuser,01 Oct 2025 14:19:09:677,systemuser,01 Oct 2025 14:19:09:677,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:21.677,20251001 14:19:09.677,20251001 14:19:09.677,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Columbia-Suicide Severity Rating Scale - Baseline/Screening Version,0/0/V,,First Attempt Date,Auto,16231788,Closed,systemuser,01 Oct 2025 14:16:08:900,systemuser,01 Oct 2025 14:16:21:617,systemuser,01 Oct 2025 14:16:21:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 14:16:08.900,20251001 14:16:21.617,20251001 14:16:21.617,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,16834779,Closed,systemuser,06 Nov 2025 14:31:32:913,MSedlackova11,06 Nov 2025 14:36:14:620,shyamaprasad972,07 Nov 2025 11:09:39:383,,0,1,"Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.",added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:31:32.913,20251106 14:36:14.620,20251107 11:09:39.383,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,16834843,Closed,systemuser,06 Nov 2025 14:35:49:403,systemuser,06 Nov 2025 14:35:59:440,systemuser,06 Nov 2025 14:35:59:443,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:35:49.403,20251106 14:35:59.440,20251106 14:35:59.443,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16410010,Closed,kavya@1510,15 Oct 2025 07:10:47:303,MSedlackova11,15 Oct 2025 13:56:15:547,kavya@1510,15 Oct 2025 14:00:33:580,,0,0,Eligibility: Kindly update details in the AE page with Yes or No.,CORRECTED,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 07:10:47.303,20251015 13:56:15.547,20251015 14:00:33.580,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Inclusion/Exclusion Criteria,0/0/N,1,Criterion ID,Auto,16834772,Closed,systemuser,06 Nov 2025 14:31:32:743,systemuser,06 Nov 2025 14:34:48:187,systemuser,06 Nov 2025 14:34:48:187,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:31:32.743,20251106 14:34:48.187,20251106 14:34:48.187,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Stop date,Auto,16834812,Closed,systemuser,06 Nov 2025 14:33:17:863,MSedlackova11,06 Nov 2025 14:34:08:460,shyamaprasad972,07 Nov 2025 11:10:12:630,,0,1,"Subject is completed or discontinued. However, stop date is not provided. Please review.",it is continuing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:33:17.863,20251106 14:34:08.460,20251107 11:10:12.630,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Body Mass Index,Auto,16229513,Closed,systemuser,01 Oct 2025 12:57:48:400,systemuser,01 Oct 2025 12:59:41:503,systemuser,01 Oct 2025 12:59:41:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 12:57:48.400,20251001 12:59:41.503,20251001 12:59:41.503,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16229514,Closed,systemuser,01 Oct 2025 12:57:48:427,systemuser,01 Oct 2025 12:59:41:503,systemuser,01 Oct 2025 12:59:41:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 12:57:48.427,20251001 12:59:41.503,20251001 12:59:41.503,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,18278825,Closed,systemuser,02 Jan 2026 14:42:28:203,systemuser,02 Jan 2026 14:42:46:143,systemuser,02 Jan 2026 14:42:46:147,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 14:42:28.203,20260102 14:42:46.143,20260102 14:42:46.147,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120003,Screen Failed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,DM,18246903,Closed,Ashwini201,30 Dec 2025 06:53:13:560,MSedlackova11,02 Jan 2026 14:42:33:307,shyamaprasad972,05 Jan 2026 07:10:49:127,,3,3,"DM: This site is not approved for the DREEM Beacon Device. Please verify and update the data as appropriate, else clarify.",ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251230 06:53:13.560,20260102 14:42:33.307,20260105 07:10:49.127,48,335,335,7,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Adverse Events/Serious AEs,Adverse Events/Serious Aes,0/0/V,,Were any adverse events experienced?,DM,20133773,Closed,Ashwini201,23 Apr 2026 08:27:18:727,MSedlackova11,27 Apr 2026 12:52:46:090,Ashwini201,29 Apr 2026 08:44:39:860,,4,2,"DM: Please complete or inactivate LOGLINE#2, Else clarify.",ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 08:27:18.727,20260427 12:52:46.090,20260429 08:44:39.860,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Indication,Auto,16231261,Closed,systemuser,01 Oct 2025 13:47:02:243,systemuser,01 Oct 2025 13:47:33:867,systemuser,01 Oct 2025 13:47:33:867,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 13:47:02.243,20251001 13:47:33.867,20251001 13:47:33.867,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,5,Indication,Auto,16231263,Closed,systemuser,01 Oct 2025 13:47:34:370,systemuser,01 Oct 2025 13:50:59:060,systemuser,01 Oct 2025 13:50:59:060,,0,0,"""Is this a medication/therapy taken for current episode of depression?"" is 'No', however, Indication is selected as 'Trial Indication'. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 13:47:34.370,20251001 13:50:59.060,20251001 13:50:59.060,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260310 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19340262,Closed,systemuser,06 Mar 2026 11:50:06:193,systemuser,10 Mar 2026 15:39:58:500,systemuser,10 Mar 2026 15:39:58:640,,4,0,NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 11:50:06.193,20260310 15:39:58.500,20260310 15:39:58.640,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260315 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,19516929,Closed,systemuser,15 Mar 2026 12:33:38:157,systemuser,15 Mar 2026 12:36:31:197,systemuser,15 Mar 2026 12:36:31:317,,0,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260315 12:33:38.157,20260315 12:36:31.197,20260315 12:36:31.317,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,17673478,Closed,systemuser,05 Dec 2025 12:21:20:463,,,systemuser,05 Dec 2025 13:58:28:617,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 12:21:20.463,,20251205 13:58:28.617,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,What was the subject's primary reason for treatment discontinuation/completion?,DM,19541641,Closed,Juhita@ksha4,17 Mar 2026 05:56:39:457,MSedlackova11,29 Mar 2026 10:05:43:130,Juhita@ksha4,30 Mar 2026 13:07:53:263,,12,1,Medical Review I-3063261: Please revise reason in line with study expectations for similar scenarios. Please consult SM as needed.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 05:56:39.457,20260329 10:05:43.130,20260330 13:07:53.263,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening to end of study,Treatment Disposition - Stabilization,0/0/V,,Treatment Disposition Date,DM,19554002,Closed,JThoma858,17 Mar 2026 09:57:58:647,MSedlackova11,29 Mar 2026 10:05:10:277,JThoma858,30 Mar 2026 04:56:11:690,,12,1,DM: Please note as per the completion guideline disposition date  is the the date the decision was taken to discontinue the subject from the treatment. Kindly check and update the treatment disposition date,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 09:57:58.647,20260329 10:05:10.277,20260330 04:56:11.690,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,What was the subject's primary reason for trial discontinuation/completion?,DM,19541860,Closed,Juhita@ksha4,17 Mar 2026 06:05:40:843,MSedlackova11,02 Apr 2026 13:37:35:983,Juhita@ksha4,02 Apr 2026 14:55:52:683,,16,0,Medical Review I-3063263: Please revise reason in line with study expectations for similar scenarios when a patient completes the second follow up visit. Please consult SM as necessary.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260317 06:05:40.843,20260402 13:37:35.983,20260402 14:55:52.683,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Arizona Sexual Experiences Scale Summary,0/0/N,,Which version of the Arizona Sexual Experiences Scale will be used?,DM,17645250,Closed,shyamaprasad972,05 Dec 2025 07:48:31:100,MSedlackova11,05 Dec 2025 14:00:13:793,Ashwini201,09 Dec 2025 10:16:42:193,,0,4,"DM: Kindly update the 'Arizona Sexual Experiences Scale Summary' form, it is asking which ASEX will be used for this subject, not if it was completed during this visit. Please update to generate form for V3 assessment.",was done at V3,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 07:48:31.100,20251205 14:00:13.793,20251209 10:16:42.193,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Arizona Sexual Experiences Scale Summary,0/0/N,,Which version of the Arizona Sexual Experiences Scale will be used?,DM,17781220 (17645250),Closed,Ashwini201,09 Dec 2025 10:16:42:337,MSedlackova11,27 Dec 2025 23:26:08:920,shyamaprasad972,29 Dec 2025 14:30:28:973,,18,2,RQ-DM1: Thank you for the response. Please update this field to generate form for V3 assessment.,ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251209 10:16:42.337,20251227 23:26:08.920,20251229 14:30:28.973,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,16422739,Closed,kavya@1510,15 Oct 2025 14:01:25:720,MSedlackova11,15 Oct 2025 14:02:33:850,kavya@1510,21 Oct 2025 11:18:05:757,,0,6,Eligibility: Kindly update details in the AE page with Yes or No. ,ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251015 14:01:25.720,20251015 14:02:33.850,20251021 11:18:05.757,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,DM,17288446,Closed,Ashwini201,25 Nov 2025 14:49:33:530,MSedlackova11,04 Dec 2025 13:21:40:473,shyamaprasad972,05 Dec 2025 07:49:16:583,,9,1,"DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.",completed,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251125 14:49:33.530,20251204 13:21:40.473,20251205 07:49:16.583,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Neurologic Examination,0/0/N,5,Are there any findings?,Auto,17626240,Closed,systemuser,04 Dec 2025 12:51:57:570,systemuser,04 Dec 2025 12:52:02:923,systemuser,04 Dec 2025 12:52:02:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 12:51:57.570,20251204 12:52:02.923,20251204 12:52:02.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17626164,Closed,systemuser,04 Dec 2025 12:49:46:343,systemuser,04 Dec 2025 12:49:56:777,systemuser,04 Dec 2025 12:49:56:780,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251204 12:49:46.343,20251204 12:49:56.777,20251204 12:49:56.780,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Psychotherapy v2.0,0/0/N,1,Stop date,Auto,19516931,Closed,systemuser,15 Mar 2026 12:33:38:177,MSedlackova11,15 Mar 2026 12:35:18:163,Ashwini201,16 Mar 2026 12:23:25:057,,0,1,"Subject is completed or discontinued. However, stop date is not provided. Please review.",it is ongoing,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260315 12:33:38.177,20260315 12:35:18.163,20260316 12:23:25.057,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16230727,Closed,systemuser,01 Oct 2025 13:15:16:980,MSedlackova11,01 Oct 2025 13:59:00:833,Ashwini201,03 Oct 2025 07:48:28:187,,0,2,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 13:15:16.980,20251001 13:59:00.833,20251003 07:48:28.187,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16230726,Closed,systemuser,01 Oct 2025 13:15:16:943,systemuser,01 Oct 2025 13:15:26:637,systemuser,01 Oct 2025 13:15:26:640,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251001 13:15:16.943,20251001 13:15:26.637,20251001 13:15:26.640,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,Auto,16487971,Closed,systemuser,21 Oct 2025 07:20:42:620,systemuser,21 Oct 2025 07:21:38:120,systemuser,21 Oct 2025 07:21:38:123,,0,0,"Assessment is 'Dreem Device'. However, 'If Applicable, Device ID' is missing. Please provide.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251021 07:20:42.620,20251021 07:21:38.120,20251021 07:21:38.123,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Assessment Completed?,DM,16960585,Closed,Ashwini201,12 Nov 2025 15:42:33:073,MSedlackova11,24 Nov 2025 08:01:12:397,Ashwini201,25 Nov 2025 08:26:52:150,,12,1,"DM: This site is not approved for the DREEM Beacon Device. Please verify and update the data as appropriate, else clarify.",ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251112 15:42:33.073,20251124 08:01:12.397,20251125 08:26:52.150,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,16521580,Closed,systemuser,22 Oct 2025 09:57:25:963,,,systemuser,06 Nov 2025 14:24:50:140,,,15,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 09:57:25.963,,20251106 14:24:50.140,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,17673477,Closed,systemuser,05 Dec 2025 12:21:20:447,,,systemuser,05 Dec 2025 13:59:01:830,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 12:21:20.447,,20251205 13:59:01.830,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,18276247,Closed,systemuser,02 Jan 2026 10:01:54:617,,,systemuser,02 Jan 2026 14:43:31:460,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 10:01:54.617,,20260102 14:43:31.460,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Amphetamine,Auto,18131311,Closed,systemuser,19 Dec 2025 11:51:32:227,systemuser,19 Dec 2025 11:52:01:903,systemuser,19 Dec 2025 11:52:01:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.227,20251219 11:52:01.903,20251219 11:52:01.907,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Barbiturate,Auto,18131312,Closed,systemuser,19 Dec 2025 11:51:32:233,systemuser,19 Dec 2025 11:52:01:907,systemuser,19 Dec 2025 11:52:01:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.233,20251219 11:52:01.907,20251219 11:52:01.907,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,18131313,Closed,systemuser,19 Dec 2025 11:51:32:240,systemuser,19 Dec 2025 11:52:01:907,systemuser,19 Dec 2025 11:52:01:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.240,20251219 11:52:01.907,20251219 11:52:01.907,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Cannabinoids,Auto,18131314,Closed,systemuser,19 Dec 2025 11:51:32:250,systemuser,19 Dec 2025 11:52:01:907,systemuser,19 Dec 2025 11:52:01:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.250,20251219 11:52:01.907,20251219 11:52:01.907,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Cocaine,Auto,18131315,Closed,systemuser,19 Dec 2025 11:51:32:257,systemuser,19 Dec 2025 11:52:01:907,systemuser,19 Dec 2025 11:52:01:907,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.257,20251219 11:52:01.907,20251219 11:52:01.907,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Collection Time,Auto,18131310,Closed,systemuser,19 Dec 2025 11:51:32:220,systemuser,19 Dec 2025 11:52:01:923,systemuser,19 Dec 2025 11:52:01:923,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.220,20251219 11:52:01.923,20251219 11:52:01.923,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,18131316,Closed,systemuser,19 Dec 2025 11:51:32:267,systemuser,19 Dec 2025 11:52:01:927,systemuser,19 Dec 2025 11:52:01:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.267,20251219 11:52:01.927,20251219 11:52:01.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Methamphetamine,Auto,18131318,Closed,systemuser,19 Dec 2025 11:51:32:280,systemuser,19 Dec 2025 11:52:01:927,systemuser,19 Dec 2025 11:52:01:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.280,20251219 11:52:01.927,20251219 11:52:01.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Methadone,Auto,18131317,Closed,systemuser,19 Dec 2025 11:51:32:270,systemuser,19 Dec 2025 11:52:01:927,systemuser,19 Dec 2025 11:52:01:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.270,20251219 11:52:01.927,20251219 11:52:01.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Opiate,Auto,18131319,Closed,systemuser,19 Dec 2025 11:51:32:287,systemuser,19 Dec 2025 11:52:01:927,systemuser,19 Dec 2025 11:52:01:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.287,20251219 11:52:01.927,20251219 11:52:01.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.4 Induction (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,18131309,Closed,systemuser,19 Dec 2025 11:51:32:207,systemuser,19 Dec 2025 11:52:01:927,systemuser,19 Dec 2025 11:52:01:927,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251219 11:51:32.207,20251219 11:52:01.927,20251219 11:52:01.927,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 1.5 Induction (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18279104,Closed,systemuser,02 Jan 2026 15:09:02:620,systemuser,02 Jan 2026 15:09:09:533,systemuser,02 Jan 2026 15:09:09:537,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260102 15:09:02.620,20260102 15:09:09.533,20260102 15:09:09.537,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.2 Stabilization (1),Date of Visit,0/0/N,,Type of Contact,Auto,18683628,Closed,systemuser,29 Jan 2026 14:32:35:797,systemuser,29 Jan 2026 14:33:30:447,systemuser,29 Jan 2026 14:33:30:450,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 14:32:35.797,20260129 14:33:30.447,20260129 14:33:30.450,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.2 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18715989,Closed,systemuser,02 Feb 2026 08:32:18:603,systemuser,02 Feb 2026 08:32:25:307,systemuser,02 Feb 2026 08:32:25:307,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 08:32:18.603,20260202 08:32:25.307,20260202 08:32:25.307,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.3 Stabilization (1),Alcohol Test,0/0/N,,Alcohol Test Result,Auto,18961796,Closed,systemuser,15 Feb 2026 12:02:14:737,systemuser,15 Feb 2026 12:02:24:313,systemuser,15 Feb 2026 12:02:24:317,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:02:14.737,20260215 12:02:24.313,20260215 12:02:24.317,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.3 Stabilization (1),Alcohol Test,0/0/N,,Collection Date,Auto,18961795,Closed,systemuser,15 Feb 2026 12:02:14:730,systemuser,15 Feb 2026 12:02:24:317,systemuser,15 Feb 2026 12:02:24:317,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:02:14.730,20260215 12:02:24.317,20260215 12:02:24.317,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.3 Stabilization (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18961794,Closed,systemuser,15 Feb 2026 12:01:18:463,systemuser,15 Feb 2026 12:01:28:403,systemuser,15 Feb 2026 12:01:28:407,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:01:18.463,20260215 12:01:28.403,20260215 12:01:28.407,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Neurologic Examination,0/0/N,,Date of Assessment,Auto,19449004,Closed,systemuser,10 Mar 2026 15:32:30:580,systemuser,10 Mar 2026 15:32:41:483,systemuser,10 Mar 2026 15:32:41:483,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260310 15:32:30.580,20260310 15:32:41.483,20260310 15:32:41.483,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,19341664,Closed,systemuser,06 Mar 2026 12:42:14:640,systemuser,06 Mar 2026 12:43:28:487,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.640,20260306 12:43:28.487,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,19341665,Closed,systemuser,06 Mar 2026 12:42:14:643,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.643,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,19341666,Closed,systemuser,06 Mar 2026 12:42:14:650,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.650,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,19341667,Closed,systemuser,06 Mar 2026 12:42:14:657,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.657,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,19341668,Closed,systemuser,06 Mar 2026 12:42:14:663,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.663,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,19341669,Closed,systemuser,06 Mar 2026 12:42:14:670,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.670,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,19341670,Closed,systemuser,06 Mar 2026 12:42:14:673,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.673,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,19341671,Closed,systemuser,06 Mar 2026 12:42:14:680,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.680,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,19341672,Closed,systemuser,06 Mar 2026 12:42:14:683,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.683,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,19341673,Closed,systemuser,06 Mar 2026 12:42:14:690,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.690,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,19341663,Closed,systemuser,06 Mar 2026 12:42:14:627,systemuser,06 Mar 2026 12:43:28:490,systemuser,06 Mar 2026 12:43:28:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:42:14.627,20260306 12:43:28.490,20260306 12:43:28.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Physician Withdrawal Checklist (PWC),0/0/N,,Was the questionnaire completed?,Auto,19471697,Closed,systemuser,11 Mar 2026 16:03:38:797,systemuser,11 Mar 2026 16:04:43:570,systemuser,11 Mar 2026 16:04:43:570,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260311 16:03:38.797,20260311 16:04:43.570,20260311 16:04:43.570,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Sheehan Disability Scale,0/0/N,,Was the questionnaire completed?,Auto,19341765,Closed,systemuser,06 Mar 2026 12:47:43:397,systemuser,06 Mar 2026 12:48:18:410,systemuser,06 Mar 2026 12:48:18:413,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 12:47:43.397,20260306 12:48:18.410,20260306 12:48:18.413,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 2.4 Stabilization,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19342217,Closed,systemuser,06 Mar 2026 13:16:12:610,systemuser,06 Mar 2026 13:16:31:707,systemuser,06 Mar 2026 13:16:31:710,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260306 13:16:12.610,20260306 13:16:31.707,20260306 13:16:31.710,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,1. Difficulty falling asleep:,Auto,16519483,Closed,systemuser,22 Oct 2025 08:45:48:673,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.673,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,2. Difficulty staying asleep:,Auto,16519484,Closed,systemuser,22 Oct 2025 08:45:48:683,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.683,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,3. Problem waking up too early in the morning:,Auto,16519485,Closed,systemuser,22 Oct 2025 08:45:48:693,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.693,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,4. How SATISFIED/dissatisfied are you with your current sleep pattern?,Auto,16519486,Closed,systemuser,22 Oct 2025 08:45:48:703,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.703,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,"5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?",Auto,16519487,Closed,systemuser,22 Oct 2025 08:45:48:713,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.713,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?,Auto,16519488,Closed,systemuser,22 Oct 2025 08:45:48:723,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.723,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,7. How WORRIED/distressed are you about your current sleep problem?,Auto,16519489,Closed,systemuser,22 Oct 2025 08:45:48:733,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.733,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Insomnia Severity Index,0/0/N,,Was the collection date the same as the visit date?,Auto,16519482,Closed,systemuser,22 Oct 2025 08:45:48:650,systemuser,22 Oct 2025 08:53:31:897,systemuser,22 Oct 2025 08:53:31:897,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251022 08:45:48.650,20251022 08:53:31.897,20251022 08:53:31.897,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,16833887,Closed,systemuser,06 Nov 2025 13:57:18:480,systemuser,06 Nov 2025 13:57:29:487,systemuser,06 Nov 2025 13:57:29:490,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 13:57:18.480,20251106 13:57:29.487,20251106 13:57:29.490,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Body Mass Index,Auto,16833359,Closed,systemuser,06 Nov 2025 13:43:51:040,systemuser,06 Nov 2025 13:44:02:343,systemuser,06 Nov 2025 13:44:02:347,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 13:43:51.040,20251106 13:44:02.343,20251106 13:44:02.347,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16833360,Closed,systemuser,06 Nov 2025 13:43:51:220,MSedlackova11,06 Nov 2025 13:44:11:790,shyamaprasad972,07 Nov 2025 11:10:48:417,,0,1,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 13:43:51.220,20251106 13:44:11.790,20251107 11:10:48.417,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,16834530,Closed,systemuser,06 Nov 2025 14:18:43:683,MSedlackova11,06 Nov 2025 14:19:06:137,shyamaprasad972,07 Nov 2025 11:11:42:807,,0,1,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:18:43.683,20251106 14:19:06.137,20251107 11:11:42.807,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,16834529,Closed,systemuser,06 Nov 2025 14:18:43:497,systemuser,06 Nov 2025 14:18:57:887,systemuser,06 Nov 2025 14:18:57:890,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251106 14:18:43.497,20251106 14:18:57.887,20251106 14:18:57.890,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,17209098,Closed,systemuser,24 Nov 2025 07:59:37:117,MSedlackova11,24 Nov 2025 07:59:49:313,Ashwini201,25 Nov 2025 08:26:09:120,,0,1,The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.,NCS,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251124 07:59:37.117,20251124 07:59:49.313,20251125 08:26:09.120,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 8 Part 1 (1),Neurologic Examination,0/0/N,,Date of Assessment,Auto,17676107,Closed,systemuser,05 Dec 2025 13:50:50:580,systemuser,05 Dec 2025 13:50:57:630,systemuser,05 Dec 2025 13:50:57:630,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:50:50.580,20251205 13:50:57.630,20251205 13:50:57.630,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120004,Completed,Visit 8 Part 1 (1),Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,17675836,Closed,systemuser,05 Dec 2025 13:42:50:490,systemuser,05 Dec 2025 13:43:00:870,systemuser,05 Dec 2025 13:43:00:873,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20251205 13:42:50.490,20251205 13:43:00.870,20251205 13:43:00.873,48,335,335,35,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,Start Date,Site from Medical Reviewer,18899465,Closed,Mamatha.K1,12 Feb 2026 06:47:00:343,MSedlackova11,15 Feb 2026 15:42:27:497,Mamatha.K1,16 Feb 2026 05:32:45:933,,3,1,Eligibility: Please confirm if the medication has been started and has been stable for at least 12 weeks,confirm,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260212 06:47:00.343,20260215 15:42:27.497,20260216 05:32:45.933,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,3,"If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term",DM,19195662,Closed,Ashwini201,26 Feb 2026 13:44:36:187,MSedlackova11,27 Feb 2026 17:31:56:153,Ashwini201,19 Mar 2026 13:13:38:423,,1,20,DM: Kindly verify and confirm the indication.,corrected,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260226 13:44:36.187,20260227 17:31:56.153,20260319 13:13:38.423,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,Derived Medication or Therapy for coding purposes(derived field),Site from Medical Reviewer,18792212,Closed,Mamatha.K1,05 Feb 2026 16:39:22:090,MSedlackova11,08 Feb 2026 15:35:58:263,Mamatha.K1,09 Feb 2026 04:34:51:090,,3,1,Eligibility: Please clarify if this drug is Alprazolam. Thank You,ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 16:39:22.090,20260208 15:35:58.263,20260209 04:34:51.090,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,Derived Medication or Therapy for coding purposes(derived field),Site from Medical Reviewer,18821189 (18792212),Closed,Mamatha.K1,09 Feb 2026 04:34:51:230,MSedlackova11,16 Feb 2026 13:01:04:867,Mamatha.K1,18 Feb 2026 06:29:41:097,,7,2,"Eligibility: Please note, per protocol ongoing benzodiazepine are prohibited from at least 7 days prior to Day 1 until the Follow-up visit.1. Kindly comment if the subject agrees to discontinue and 2. PI assesses if the drug can be safely tapered off with a washout of 7 days to prevent rebound insomnia as per exclusion #29.",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 04:34:51.230,20260216 13:01:04.867,20260218 06:29:41.097,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,7,Indication,Auto,18781098,Closed,systemuser,05 Feb 2026 09:54:18:527,systemuser,08 Feb 2026 15:35:32:667,systemuser,08 Feb 2026 15:35:32:667,,3,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 09:54:18.527,20260208 15:35:32.667,20260208 15:35:32.667,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,8,End Date,Site from Medical Reviewer,18821191,Closed,Mamatha.K1,09 Feb 2026 04:35:58:517,MSedlackova11,16 Feb 2026 13:01:55:793,Mamatha.K1,18 Feb 2026 06:30:19:490,,7,2,"Eligibilty : Please ensure the drug is tapered off with a washout of 7 days .Kindly update the end date once done otherwise, Kindly elaborate the washout plan and tentative end - date",updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 04:35:58.517,20260216 13:01:55.793,20260218 06:30:19.490,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,8,Derived Medication or Therapy for coding purposes(derived field),Site from Medical Reviewer,18792217,Closed,Mamatha.K1,05 Feb 2026 16:40:54:237,MSedlackova11,08 Feb 2026 15:43:25:313,Mamatha.K1,09 Feb 2026 04:35:48:493,,3,1,"Eligibility: Please note, per protocol ongoing benzodiazepine are prohibited  from at least 7 days prior to Day 1 until the Follow-up visit.1. Kindly comment if the subject agrees to discontinue and 2. PI assesses if the drug can be safely tapered off with a washout of 7 days to prevent rebound insomnia as per exclusion #29.",the subject agrees to discontinue ,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 16:40:54.237,20260208 15:43:25.313,20260209 04:35:48.493,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Investigator Periodic Review Acknowledgments/ Interim Signatures ,20260521 - Periodic Investigator's EDC Review Acknowledgement,0/0/N,,"As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.",Auto,20876096,Closed,systemuser,17 May 2026 08:22:12:287,systemuser,21 May 2026 07:11:51:780,systemuser,21 May 2026 07:11:51:947,,4,0,"NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260517 08:22:12.287,20260521 07:11:51.780,20260521 07:11:51.947,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19749463,Closed,systemuser,29 Mar 2026 10:35:17:070,,,systemuser,29 Mar 2026 11:13:58:650,,,0,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 10:35:17.070,,20260329 11:13:58.650,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening to end of study,Treatment Disposition - Induction,0/0/V,,"If Withdrawal by Subject, Specify",Auto,20876091,Closed,systemuser,17 May 2026 08:18:26:750,systemuser,17 May 2026 08:22:52:613,systemuser,17 May 2026 08:22:52:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260517 08:18:26.750,20260517 08:22:52.613,20260517 08:22:52.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening to end of study,Trial Disposition Completion/ Discontinuation,0/0/V,,"If Withdrawal by Subject, Specify",Auto,20876086,Closed,systemuser,17 May 2026 08:18:26:710,systemuser,17 May 2026 08:22:11:930,systemuser,17 May 2026 08:22:11:930,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260517 08:18:26.710,20260517 08:22:11.930,20260517 08:22:11.930,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Date of Visit,0/0/N,,Subject's Status,Auto,18682836,Closed,systemuser,29 Jan 2026 13:48:12:997,systemuser,29 Jan 2026 13:48:25:033,systemuser,29 Jan 2026 13:48:25:047,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:48:12.997,20260129 13:48:25.033,20260129 13:48:25.047,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Date of Visit,0/0/N,,Did this visit occur?,Site from Medical Reviewer,18792174,Closed,Mamatha.K1,05 Feb 2026 16:35:39:150,MSedlackova11,08 Feb 2026 15:34:51:427,Mamatha.K1,09 Feb 2026 04:36:10:153,,3,1,"Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please update the response to datapoint 'Were any adverse events experienced?' as 'No'.",ok,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 16:35:39.150,20260208 15:34:51.427,20260209 04:36:10.153,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Date of Visit,0/0/N,,Type of Contact,Auto,18682837,Closed,systemuser,29 Jan 2026 13:48:13:010,systemuser,29 Jan 2026 13:48:25:233,systemuser,29 Jan 2026 13:48:25:233,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:48:13.010,20260129 13:48:25.233,20260129 13:48:25.233,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Demographics,0/0/V,,What is the subject's childbearing potential?,Site from Medical Reviewer,18792231,Closed,Mamatha.K1,05 Feb 2026 16:42:24:380,MSedlackova11,08 Feb 2026 15:34:14:597,Mamatha.K1,09 Feb 2026 04:36:25:030,,3,1,Eligibility : Please provide when was the last menses or since when is the subject Menopausal,menopausal since 2011,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260205 16:42:24.380,20260208 15:34:14.597,20260209 04:36:25.030,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Demographics,0/0/V,,What is the protocol date the subject consented to at study start?,Auto,18682843,Closed,systemuser,29 Jan 2026 13:49:02:527,systemuser,29 Jan 2026 13:49:36:793,systemuser,29 Jan 2026 13:49:36:793,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:49:02.527,20260129 13:49:36.793,20260129 13:49:36.793,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Amphetamine,Auto,18682947,Closed,systemuser,29 Jan 2026 13:55:30:143,systemuser,29 Jan 2026 13:56:01:033,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.143,20260129 13:56:01.033,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Barbiturate,Auto,18682948,Closed,systemuser,29 Jan 2026 13:55:30:150,systemuser,29 Jan 2026 13:56:01:037,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.150,20260129 13:56:01.037,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Benzodiazepine,Auto,18682949,Closed,systemuser,29 Jan 2026 13:55:30:157,systemuser,29 Jan 2026 13:56:01:037,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.157,20260129 13:56:01.037,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Cannabinoids,Auto,18682950,Closed,systemuser,29 Jan 2026 13:55:30:163,systemuser,29 Jan 2026 13:56:01:037,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.163,20260129 13:56:01.037,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Cocaine,Auto,18682951,Closed,systemuser,29 Jan 2026 13:55:30:170,systemuser,29 Jan 2026 13:56:01:037,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.170,20260129 13:56:01.037,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Collection Time,Auto,18682946,Closed,systemuser,29 Jan 2026 13:55:30:137,systemuser,29 Jan 2026 13:56:01:053,systemuser,29 Jan 2026 13:56:01:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.137,20260129 13:56:01.053,20260129 13:56:01.053,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,18682952,Closed,systemuser,29 Jan 2026 13:55:30:177,systemuser,29 Jan 2026 13:56:01:053,systemuser,29 Jan 2026 13:56:01:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.177,20260129 13:56:01.053,20260129 13:56:01.053,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Methamphetamine,Auto,18682954,Closed,systemuser,29 Jan 2026 13:55:30:193,systemuser,29 Jan 2026 13:56:01:053,systemuser,29 Jan 2026 13:56:01:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.193,20260129 13:56:01.053,20260129 13:56:01.053,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Methadone,Auto,18682953,Closed,systemuser,29 Jan 2026 13:55:30:183,systemuser,29 Jan 2026 13:56:01:053,systemuser,29 Jan 2026 13:56:01:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.183,20260129 13:56:01.053,20260129 13:56:01.053,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Opiate,Auto,18682955,Closed,systemuser,29 Jan 2026 13:55:30:200,systemuser,29 Jan 2026 13:56:01:053,systemuser,29 Jan 2026 13:56:01:053,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.200,20260129 13:56:01.053,20260129 13:56:01.053,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,18682945,Closed,systemuser,29 Jan 2026 13:55:30:120,systemuser,29 Jan 2026 13:56:01:037,systemuser,29 Jan 2026 13:56:01:037,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260129 13:55:30.120,20260129 13:56:01.037,20260129 13:56:01.037,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,General Medical History,0/0/N,1,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18812720,Closed,Mamatha.K1,06 Feb 2026 16:08:54:353,MSedlackova11,08 Feb 2026 15:40:13:913,Mamatha.K1,09 Feb 2026 04:36:47:750,,2,1,Eligibility: Kindly confirm  if any frequent exacerbation/flares of thyroiditis and functional impact of the reported MH 2.  Please comment on the clinical stability of the subject in order to participate in the trial as per protocol instructions without any interference to continue in the entire duration of the trial .,"patient is stable, without any interference to continue",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260206 16:08:54.353,20260208 15:40:13.913,20260209 04:36:47.750,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,General Medical History,0/0/N,3,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18812736,Closed,Mamatha.K1,06 Feb 2026 16:12:14:190,MSedlackova11,08 Feb 2026 15:37:56:797,Mamatha.K1,09 Feb 2026 04:36:55:503,,2,1,"Eligibility : Please comment on the course of this disease, any complications or cardiovascular events like MI, stroke, TIA, Unstable angina etc.2.Any history of hospitalisation and re-confirm the plan for medical management if needed during the trial 3. Please comment on the clinical stability of the subject in order to participate without any interference to continue in the entire duration of the trial ","patient is stable, clinically insignificant,patient does not have in MH any cardiovascular events",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260206 16:12:14.190,20260208 15:37:56.797,20260209 04:36:55.503,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,General Medical History,0/0/N,3,Is the medical history disease/condition or event still ongoing?,DM,19835290,Closed,JThoma858,06 Apr 2026 12:52:33:423,MSedlackova11,09 Apr 2026 09:43:19:363,JThoma858,13 Apr 2026 07:24:22:000,,3,4,Medical Review  I-3116195: Kindly mention the clinical stability of the MH which is still ongoing,it is ongoing but patient is stable,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260406 12:52:33.423,20260409 09:43:19.363,20260413 07:24:22.000,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18812745,Closed,Mamatha.K1,06 Feb 2026 16:14:45:400,MSedlackova11,08 Feb 2026 15:41:23:573,Mamatha.K1,09 Feb 2026 04:37:03:177,,2,1,"Eligibility: 1.Kindly comment on details like any exacerbation or Acute episode ,  frequency of acute episode, any hospitalization in recent past , whether potential intervention required.  2. Please comment on the severity of the condition and clinical stability of the subject in order to participate in the trial without any interference to continue in the entire duration of the trial .  3. Kindly confirm  if Subject meets INC 8 and EXC 32 is ruled out.","patient is stable, without any interference to continue, no any acute episodes in past,patient is strong smoker",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260206 16:14:45.400,20260208 15:41:23.573,20260209 04:37:03.177,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Screening Visit 1,General Medical History,0/0/N,4,What is the verbatim term for the medical history condition/event?,Site from Medical Reviewer,18822986,Closed,Mamatha.K1,09 Feb 2026 07:46:42:093,MSedlackova11,16 Feb 2026 12:55:13:720,Mamatha.K1,18 Feb 2026 06:29:12:203,,7,2,"Eligibility: Given that the trigger for this condition is smoking, and subject continues to be a strong smoker 1. Please re-confirm if subject is clinically stable as per inclusion 8. (2). Please confirm that there would not be any requirement of or any planned surgical intervention such that exclusion 32 is ruled out","subject is clinically stable , no any planned surgical intervention",42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260209 07:46:42.093,20260216 12:55:13.720,20260218 06:29:12.203,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,End Date,DM,20099506,Closed,Juhita@ksha4,22 Apr 2026 06:33:28:410,MSedlackova11,22 Apr 2026 14:56:26:483,Juhita@ksha4,24 Apr 2026 08:56:42:920,,0,2,Medical Review I-5369430: Please provide end date.,added,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 06:33:28.410,20260422 14:56:26.483,20260424 08:56:42.920,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,18965787,Closed,systemuser,15 Feb 2026 14:56:50:580,,,systemuser,16 Feb 2026 12:55:44:460,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 14:56:50.580,,20260216 12:55:44.460,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,19749462,Closed,systemuser,29 Mar 2026 10:35:17:060,,,systemuser,29 Mar 2026 11:14:28:270,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 10:35:17.060,,20260329 11:14:28.270,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.3 Induction (1),Date of Visit,0/0/N,,Visit Start Date,Auto,19871218,Closed,systemuser,08 Apr 2026 13:23:12:900,systemuser,09 Apr 2026 09:36:46:023,systemuser,09 Apr 2026 09:36:46:023,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 13:23:12.900,20260409 09:36:46.023,20260409 09:36:46.023,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.4 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19886910,Closed,systemuser,09 Apr 2026 09:38:30:600,systemuser,09 Apr 2026 09:38:59:997,systemuser,09 Apr 2026 09:39:00:003,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260409 09:38:30.600,20260409 09:38:59.997,20260409 09:39:00.003,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Intensity of IdeationMost Severe Ideation,Auto,20435223,Closed,systemuser,27 Apr 2026 12:46:56:490,systemuser,27 Apr 2026 12:48:15:383,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.490,20260427 12:48:15.383,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Frequency,Auto,20435224,Closed,systemuser,27 Apr 2026 12:46:56:503,systemuser,27 Apr 2026 12:48:15:397,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.503,20260427 12:48:15.397,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Duration,Auto,20435225,Closed,systemuser,27 Apr 2026 12:46:56:513,systemuser,27 Apr 2026 12:48:15:397,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.513,20260427 12:48:15.397,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Controllability,Auto,20435226,Closed,systemuser,27 Apr 2026 12:46:56:520,systemuser,27 Apr 2026 12:48:15:397,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.520,20260427 12:48:15.397,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Deterrents,Auto,20435227,Closed,systemuser,27 Apr 2026 12:46:56:527,systemuser,27 Apr 2026 12:48:15:397,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.527,20260427 12:48:15.397,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Reasons for Ideation,Auto,20435228,Closed,systemuser,27 Apr 2026 12:46:56:533,systemuser,27 Apr 2026 12:48:15:397,systemuser,27 Apr 2026 12:48:15:397,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:46:56.533,20260427 12:48:15.397,20260427 12:48:15.397,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,20156953,Closed,systemuser,23 Apr 2026 16:05:56:010,systemuser,23 Apr 2026 16:07:01:793,systemuser,23 Apr 2026 16:07:01:793,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.010,20260423 16:07:01.793,20260423 16:07:01.793,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,20156954,Closed,systemuser,23 Apr 2026 16:05:56:017,systemuser,23 Apr 2026 16:07:01:793,systemuser,23 Apr 2026 16:07:01:793,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.017,20260423 16:07:01.793,20260423 16:07:01.793,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,20156955,Closed,systemuser,23 Apr 2026 16:05:56:023,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.023,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,20156956,Closed,systemuser,23 Apr 2026 16:05:56:040,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.040,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,20156957,Closed,systemuser,23 Apr 2026 16:05:56:067,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.067,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,20156958,Closed,systemuser,23 Apr 2026 16:05:56:090,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.090,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,20156959,Closed,systemuser,23 Apr 2026 16:05:56:317,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.317,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,20156960,Closed,systemuser,23 Apr 2026 16:05:56:323,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.323,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,20156961,Closed,systemuser,23 Apr 2026 16:05:56:330,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.330,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,20156962,Closed,systemuser,23 Apr 2026 16:05:56:337,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.337,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,20156963,Closed,systemuser,23 Apr 2026 16:05:56:343,systemuser,23 Apr 2026 16:07:02:510,systemuser,23 Apr 2026 16:07:02:510,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.343,20260423 16:07:02.510,20260423 16:07:02.510,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Rater's Initials,Auto,20156952,Closed,systemuser,23 Apr 2026 16:05:56:003,systemuser,23 Apr 2026 16:07:01:817,systemuser,23 Apr 2026 16:07:01:817,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:56.003,20260423 16:07:01.817,20260423 16:07:01.817,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,20156951,Closed,systemuser,23 Apr 2026 16:05:55:983,systemuser,23 Apr 2026 16:07:01:797,systemuser,23 Apr 2026 16:07:01:797,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260423 16:05:55.983,20260423 16:07:01.797,20260423 16:07:01.797,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,20435169,Closed,systemuser,27 Apr 2026 12:45:01:553,systemuser,27 Apr 2026 12:45:22:253,systemuser,27 Apr 2026 12:45:22:257,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:01.553,20260427 12:45:22.253,20260427 12:45:22.257,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Pulse,Auto,20435167,Closed,systemuser,27 Apr 2026 12:45:01:523,systemuser,27 Apr 2026 12:45:22:267,systemuser,27 Apr 2026 12:45:22:267,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:01.523,20260427 12:45:22.267,20260427 12:45:22.267,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,20435168,Closed,systemuser,27 Apr 2026 12:45:01:537,systemuser,27 Apr 2026 12:45:22:270,systemuser,27 Apr 2026 12:45:22:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:01.537,20260427 12:45:22.270,20260427 12:45:22.270,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,20435165,Closed,systemuser,27 Apr 2026 12:45:01:487,systemuser,27 Apr 2026 12:45:22:270,systemuser,27 Apr 2026 12:45:22:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:01.487,20260427 12:45:22.270,20260427 12:45:22.270,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature,Auto,20435166,Closed,systemuser,27 Apr 2026 12:45:01:513,systemuser,27 Apr 2026 12:45:22:270,systemuser,27 Apr 2026 12:45:22:270,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:01.513,20260427 12:45:22.270,20260427 12:45:22.270,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20435208,Closed,systemuser,27 Apr 2026 12:45:22:340,systemuser,27 Apr 2026 12:45:30:690,systemuser,27 Apr 2026 12:45:30:690,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260427 12:45:22.340,20260427 12:45:30.690,20260427 12:45:30.690,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 3 Part 1 Baseline,Drug Testing,0/0/N,,Collection Time,Auto,18976354,Closed,systemuser,16 Feb 2026 13:03:48:793,systemuser,17 Feb 2026 09:28:33:773,systemuser,17 Feb 2026 09:28:33:777,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 13:03:48.793,20260217 09:28:33.773,20260217 09:28:33.777,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 3 Part 1 Baseline,Neurologic Examination,0/0/N,,Date of Assessment,Auto,18976395,Closed,systemuser,16 Feb 2026 13:05:12:760,systemuser,16 Feb 2026 13:05:43:377,systemuser,16 Feb 2026 13:05:43:377,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 13:05:12.760,20260216 13:05:43.377,20260216 13:05:43.377,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 3 Part 1 Baseline,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18976324,Closed,systemuser,16 Feb 2026 13:03:14:657,systemuser,16 Feb 2026 13:03:27:280,systemuser,16 Feb 2026 13:03:27:280,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260216 13:03:14.657,20260216 13:03:27.280,20260216 13:03:27.280,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18986740,Closed,systemuser,17 Feb 2026 09:29:12:210,systemuser,17 Feb 2026 09:29:19:157,systemuser,17 Feb 2026 09:29:19:157,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 09:29:12.210,20260217 09:29:19.157,20260217 09:29:19.157,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Alcohol Test,0/0/N,,Alcohol Test Result,Auto,19217194,Closed,systemuser,27 Feb 2026 16:48:34:277,systemuser,27 Feb 2026 16:48:43:513,systemuser,27 Feb 2026 16:48:43:517,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:34.277,20260227 16:48:43.513,20260227 16:48:43.517,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Alcohol Test,0/0/N,,Collection Date,Auto,19217193,Closed,systemuser,27 Feb 2026 16:48:34:237,systemuser,27 Feb 2026 16:48:43:517,systemuser,27 Feb 2026 16:48:43:517,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:34.237,20260227 16:48:43.517,20260227 16:48:43.517,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Ideation1. Wish to be Dead,Auto,19217205,Closed,systemuser,27 Feb 2026 16:48:52:967,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:52.967,20260227 16:49:40.617,20260227 16:49:40.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,2. Non-Specific Active Suicidal Thoughts,Auto,19217206,Closed,systemuser,27 Feb 2026 16:48:53:040,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.040,20260227 16:49:40.617,20260227 16:49:40.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal BehaviorActual Attempt,Auto,19217207,Closed,systemuser,27 Feb 2026 16:48:53:187,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.187,20260227 16:49:40.617,20260227 16:49:40.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Has subject engaged in Non-Suicidal Self-Injurious Behavior?,Auto,19217208,Closed,systemuser,27 Feb 2026 16:48:53:243,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.243,20260227 16:49:40.617,20260227 16:49:40.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Interrupted Attempt,Auto,19217209,Closed,systemuser,27 Feb 2026 16:48:53:283,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:617,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.283,20260227 16:49:40.617,20260227 16:49:40.617,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Aborted Attempt,Auto,19217210,Closed,systemuser,27 Feb 2026 16:48:53:347,systemuser,27 Feb 2026 16:49:40:617,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.347,20260227 16:49:40.617,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Preparatory Acts or Behavior,Auto,19217211,Closed,systemuser,27 Feb 2026 16:48:53:400,systemuser,27 Feb 2026 16:49:40:620,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.400,20260227 16:49:40.620,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicidal Behavior,Auto,19217212,Closed,systemuser,27 Feb 2026 16:48:53:443,systemuser,27 Feb 2026 16:49:40:620,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.443,20260227 16:49:40.620,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Suicide,Auto,19217213,Closed,systemuser,27 Feb 2026 16:48:53:483,systemuser,27 Feb 2026 16:49:40:620,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:53.483,20260227 16:49:40.620,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Rater's Initials,Auto,19217204,Closed,systemuser,27 Feb 2026 16:48:52:927,systemuser,27 Feb 2026 16:49:40:620,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:52.927,20260227 16:49:40.620,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Columbia-Suicide Severity Rating Scale - Since Last Visit,0/0/V,,Was the collection date the same as the visit date?,Auto,19217203,Closed,systemuser,27 Feb 2026 16:48:52:863,systemuser,27 Feb 2026 16:49:40:620,systemuser,27 Feb 2026 16:49:40:620,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 16:48:52.863,20260227 16:49:40.620,20260227 16:49:40.620,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19217459,Closed,systemuser,27 Feb 2026 17:17:05:787,systemuser,27 Feb 2026 17:17:11:530,systemuser,27 Feb 2026 17:17:11:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 17:17:05.787,20260227 17:17:11.530,20260227 17:17:11.530,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 8 Part 1 (1),Date of Visit,0/0/N,,Subject's Status,Auto,19694111,Closed,systemuser,25 Mar 2026 11:09:05:177,systemuser,29 Mar 2026 10:35:16:890,systemuser,29 Mar 2026 10:35:16:893,,4,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 11:09:05.177,20260329 10:35:16.890,20260329 10:35:16.893,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120005,Early Terminated,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19749429,Closed,systemuser,29 Mar 2026 10:16:23:373,systemuser,29 Mar 2026 10:17:44:020,systemuser,29 Mar 2026 10:17:44:020,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 10:16:23.373,20260329 10:17:44.020,20260329 10:17:44.020,48,335,335,25,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Concomitant Therapy,Concomitant Therapy / Medication,0/0/V,1,If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?,Auto,18723370,Closed,systemuser,02 Feb 2026 14:11:04:160,systemuser,02 Feb 2026 14:11:15:090,systemuser,02 Feb 2026 14:11:15:090,,0,0,"Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.",Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 14:11:04.160,20260202 14:11:15.090,20260202 14:11:15.090,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening to end of study,Perceived Treatment Group Assignment,0/0/N,,Questionnaire completed?,Auto,19699105,Closed,systemuser,25 Mar 2026 14:02:56:530,,,systemuser,29 Mar 2026 11:11:38:763,,,4,Please enter Yes or No if questionnaire was completed.,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 14:02:56.530,,20260329 11:11:38.763,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Physical Examination,0/0/N,,Was the collection date the same as the visit date?,Auto,18985111,Closed,systemuser,17 Feb 2026 07:26:06:620,systemuser,17 Feb 2026 07:26:18:203,systemuser,17 Feb 2026 07:26:18:203,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 07:26:06.620,20260217 07:26:18.203,20260217 07:26:18.203,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Body Mass Index,Auto,18722789,Closed,systemuser,02 Feb 2026 13:43:10:083,systemuser,02 Feb 2026 13:45:20:500,systemuser,02 Feb 2026 13:45:20:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.083,20260202 13:45:20.500,20260202 13:45:20.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Diastolic Blood Pressure,Auto,18722793,Closed,systemuser,02 Feb 2026 13:43:10:130,systemuser,02 Feb 2026 13:45:20:513,systemuser,02 Feb 2026 13:45:20:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.130,20260202 13:45:20.513,20260202 13:45:20.513,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Height,Auto,18722787,Closed,systemuser,02 Feb 2026 13:43:10:067,systemuser,02 Feb 2026 13:45:20:513,systemuser,02 Feb 2026 13:45:20:513,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.067,20260202 13:45:20.513,20260202 13:45:20.513,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Pulse,Auto,18722791,Closed,systemuser,02 Feb 2026 13:43:10:107,systemuser,02 Feb 2026 13:45:20:523,systemuser,02 Feb 2026 13:45:20:523,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.107,20260202 13:45:20.523,20260202 13:45:20.523,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Systolic Blood Pressure,Auto,18722792,Closed,systemuser,02 Feb 2026 13:43:10:117,systemuser,02 Feb 2026 13:45:20:530,systemuser,02 Feb 2026 13:45:20:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.117,20260202 13:45:20.530,20260202 13:45:20.530,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Was the collection date the same as the visit date?,Auto,18722786,Closed,systemuser,02 Feb 2026 13:43:10:050,systemuser,02 Feb 2026 13:45:20:530,systemuser,02 Feb 2026 13:45:20:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.050,20260202 13:45:20.530,20260202 13:45:20.530,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature,Auto,18722790,Closed,systemuser,02 Feb 2026 13:43:10:093,systemuser,02 Feb 2026 13:45:20:530,systemuser,02 Feb 2026 13:45:20:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.093,20260202 13:45:20.530,20260202 13:45:20.530,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18722823,Closed,systemuser,02 Feb 2026 13:45:20:607,systemuser,02 Feb 2026 13:45:28:827,systemuser,02 Feb 2026 13:45:28:830,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:45:20.607,20260202 13:45:28.827,20260202 13:45:28.830,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 1,Vital Signs,0/0/N,,Weight,Auto,18722788,Closed,systemuser,02 Feb 2026 13:43:10:077,systemuser,02 Feb 2026 13:45:20:530,systemuser,02 Feb 2026 13:45:20:530,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260202 13:43:10.077,20260202 13:45:20.530,20260202 13:45:20.530,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Screening Visit 2 (1),CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS,0/0/N,2,Reason not done,Auto,18961875,Closed,systemuser,15 Feb 2026 12:16:22:130,systemuser,15 Feb 2026 12:16:32:567,systemuser,15 Feb 2026 12:16:32:570,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:16:22.130,20260215 12:16:32.567,20260215 12:16:32.570,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Study Drug Administration (1),Study Drug Administration Double Blind Part 1,0/0/V,1,Start Date,Auto,18961895,Closed,systemuser,15 Feb 2026 12:19:48:950,,,systemuser,16 Feb 2026 12:56:01:407,,,1,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:19:48.950,,20260216 12:56:01.407,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Induction,0/0/V,1,Start Date,Auto,19699104,Closed,systemuser,25 Mar 2026 14:02:56:510,,,systemuser,29 Mar 2026 11:12:22:563,,,4,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260325 14:02:56.510,,20260329 11:12:22.563,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Study Drug Administration (1),Study Drug Administration Open Label Part 2 - Stabilization,0/0/V,1,Start Date,Auto,20115439,Closed,systemuser,22 Apr 2026 12:55:05:637,,,systemuser,22 Apr 2026 14:27:47:267,,,0,Please enter study drug administration start date as soon as it's available,QueryCloseBySystem,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:55:05.637,,20260422 14:27:47.267,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.3 Induction (1),Date of Visit,0/0/N,,Visit Start Date,Auto,19869554,Closed,systemuser,08 Apr 2026 12:29:49:227,systemuser,09 Apr 2026 09:39:55:473,systemuser,09 Apr 2026 09:39:55:473,,1,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260408 12:29:49.227,20260409 09:39:55.473,20260409 09:39:55.473,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Date of Visit,0/0/N,,Subject's Status,Auto,20115403,Closed,systemuser,22 Apr 2026 12:53:37:077,systemuser,22 Apr 2026 12:53:47:410,systemuser,22 Apr 2026 12:53:47:410,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:37.077,20260422 12:53:47.410,20260422 12:53:47.410,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,1. Loss of appetite,Auto,20118124,Closed,systemuser,22 Apr 2026 14:31:45:950,systemuser,22 Apr 2026 14:32:44:570,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:45.950,20260422 14:32:44.570,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,2. Nausea - Vomiting,Auto,20118125,Closed,systemuser,22 Apr 2026 14:31:45:960,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:45.960,20260422 14:32:44.573,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,3. Diarrhea,Auto,20118126,Closed,systemuser,22 Apr 2026 14:31:46:187,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.187,20260422 14:32:44.573,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"4. Anxiety, Nervousness",Auto,20118127,Closed,systemuser,22 Apr 2026 14:31:46:193,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.193,20260422 14:32:44.573,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,5. Irritability,Auto,20118128,Closed,systemuser,22 Apr 2026 14:31:46:207,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.207,20260422 14:32:44.573,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"6. Dysphoric Mood, Depression",Auto,20118129,Closed,systemuser,22 Apr 2026 14:31:46:213,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:573,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.213,20260422 14:32:44.573,20260422 14:32:44.573,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,7. Insomnia,Auto,20118130,Closed,systemuser,22 Apr 2026 14:31:46:220,systemuser,22 Apr 2026 14:32:44:573,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.220,20260422 14:32:44.573,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"8. Fatigue, Lethargy Lack of energy",Auto,20118131,Closed,systemuser,22 Apr 2026 14:31:46:230,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.230,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,9. Poor Coordination,Auto,20118132,Closed,systemuser,22 Apr 2026 14:31:46:243,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.243,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"10. Restlessness, Agitation",Auto,20118133,Closed,systemuser,22 Apr 2026 14:31:46:267,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.267,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,11. Diaphoresis,Auto,20118134,Closed,systemuser,22 Apr 2026 14:31:46:290,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.290,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,12. Tremor - Tremulousness,Auto,20118135,Closed,systemuser,22 Apr 2026 14:31:46:300,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.300,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,13. Dizziness - Lightheadedness,Auto,20118136,Closed,systemuser,22 Apr 2026 14:31:46:310,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.310,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,14. Headaches,Auto,20118137,Closed,systemuser,22 Apr 2026 14:31:46:317,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.317,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,15. Muscle Aches or Stiffness,Auto,20118138,Closed,systemuser,22 Apr 2026 14:31:46:337,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.337,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,16. Weakness,Auto,20118139,Closed,systemuser,22 Apr 2026 14:31:46:347,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.347,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"17. Increased acuity for sound, smell, touch or pain",Auto,20118140,Closed,systemuser,22 Apr 2026 14:31:46:360,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.360,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,18. Paresthesias,Auto,20118141,Closed,systemuser,22 Apr 2026 14:31:46:373,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.373,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"19. Difficulty concentrating, remembering",Auto,20118142,Closed,systemuser,22 Apr 2026 14:31:46:383,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.383,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,"20. Depersonalization, Derealization",Auto,20118143,Closed,systemuser,22 Apr 2026 14:31:46:397,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:46.397,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Physician Withdrawal Checklist (PWC),0/0/N,,Was the collection date the same as the visit date?,Auto,20118123,Closed,systemuser,22 Apr 2026 14:31:45:930,systemuser,22 Apr 2026 14:32:44:577,systemuser,22 Apr 2026 14:32:44:577,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:31:45.930,20260422 14:32:44.577,20260422 14:32:44.577,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Was the collection date the same as the visit date?,Auto,20115409,Closed,systemuser,22 Apr 2026 12:53:58:737,systemuser,22 Apr 2026 12:55:01:533,systemuser,22 Apr 2026 12:55:01:533,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.737,20260422 12:55:01.533,20260422 12:55:01.533,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,1. Reported Sadness,Auto,20115411,Closed,systemuser,22 Apr 2026 12:53:58:790,systemuser,22 Apr 2026 12:55:01:500,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.790,20260422 12:55:01.500,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,2. Apparent Sadness,Auto,20115412,Closed,systemuser,22 Apr 2026 12:53:58:807,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.807,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,3. Inner Tension,Auto,20115413,Closed,systemuser,22 Apr 2026 12:53:58:827,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.827,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,4. Reduced Sleep,Auto,20115414,Closed,systemuser,22 Apr 2026 12:53:58:847,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.847,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,5. Reduced Appetite,Auto,20115415,Closed,systemuser,22 Apr 2026 12:53:58:873,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.873,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,6. Concentration Difficulties,Auto,20115416,Closed,systemuser,22 Apr 2026 12:53:58:903,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.903,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,7. Lassitude,Auto,20115417,Closed,systemuser,22 Apr 2026 12:53:58:943,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.943,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,8. Inability to Feel,Auto,20115418,Closed,systemuser,22 Apr 2026 12:53:58:970,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.970,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,9. Pessimistic Thoughts,Auto,20115419,Closed,systemuser,22 Apr 2026 12:53:58:997,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.997,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,10. Suicidal Thoughts,Auto,20115420,Closed,systemuser,22 Apr 2026 12:53:59:013,systemuser,22 Apr 2026 12:55:01:503,systemuser,22 Apr 2026 12:55:01:503,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:59.013,20260422 12:55:01.503,20260422 12:55:01.503,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,TOTAL MADRS SCALE SCORE,Auto,20115421,Closed,systemuser,22 Apr 2026 12:53:59:240,systemuser,22 Apr 2026 12:55:03:393,systemuser,22 Apr 2026 12:55:03:393,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:59.240,20260422 12:55:03.393,20260422 12:55:03.393,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale,0/0/V,,Rater's Initials,Auto,20115410,Closed,systemuser,22 Apr 2026 12:53:58:773,systemuser,22 Apr 2026 12:55:01:530,systemuser,22 Apr 2026 12:55:01:533,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 12:53:58.773,20260422 12:55:01.530,20260422 12:55:01.533,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 1.5 Induction (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,20117976,Closed,systemuser,22 Apr 2026 14:28:41:393,systemuser,22 Apr 2026 14:28:47:713,systemuser,22 Apr 2026 14:28:47:713,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 14:28:41.393,20260422 14:28:47.713,20260422 14:28:47.713,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 2.2 Stabilization (1),Date of Visit,0/0/N,,Subject's Status,Auto,20932997,Closed,systemuser,20 May 2026 11:52:41:387,systemuser,20 May 2026 11:52:49:677,systemuser,20 May 2026 11:52:49:680,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260520 11:52:41.387,20260520 11:52:49.677,20260520 11:52:49.680,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Clinical Global Impression - S (Depression),0/0/V,,Rater's Initials,DM,20103928,Closed,JThoma858,22 Apr 2026 08:52:43:453,MSedlackova11,22 Apr 2026 14:19:20:460,JThoma858,24 Apr 2026 05:24:44:980,,0,2,Medical Review I-5388708: Please review if transcription accurate from source to  EDC and revise EDC entry if initial entry error occurred.,updated,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260422 08:52:43.453,20260422 14:19:20.460,20260424 05:24:44.980,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.",Auto,18961814,Closed,systemuser,15 Feb 2026 12:10:36:377,systemuser,15 Feb 2026 12:11:16:233,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.377,20260215 12:11:16.233,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"2. Feeling down, depressed, or hopeless.",Auto,18961815,Closed,systemuser,15 Feb 2026 12:10:36:383,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.383,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"3. Trouble falling or staying asleep, or sleeping too much.",Auto,18961816,Closed,systemuser,15 Feb 2026 12:10:36:390,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.390,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,4. Feeling tired or having little energy.,Auto,18961817,Closed,systemuser,15 Feb 2026 12:10:36:397,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.397,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,5. Poor appetite or overeating.,Auto,18961818,Closed,systemuser,15 Feb 2026 12:10:36:400,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.400,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.,Auto,18961819,Closed,systemuser,15 Feb 2026 12:10:36:407,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.407,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"7. Trouble concentrating on things, such as reading the newspaper or watching television.",Auto,18961820,Closed,systemuser,15 Feb 2026 12:10:36:410,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.410,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.,Auto,18961821,Closed,systemuser,15 Feb 2026 12:10:36:413,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.413,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,9. Thoughts that you would be better off dead or of hurting yourself in some way.,Auto,18961822,Closed,systemuser,15 Feb 2026 12:10:36:420,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.420,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,"If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?",Auto,18961823,Closed,systemuser,15 Feb 2026 12:10:36:427,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.427,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Patient Health Questionnaire - 9 Item,0/0/V,,Was the collection date the same as the visit date?,Auto,18961813,Closed,systemuser,15 Feb 2026 12:10:36:367,systemuser,15 Feb 2026 12:11:16:237,systemuser,15 Feb 2026 12:11:16:237,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:10:36.367,20260215 12:11:16.237,20260215 12:11:16.237,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,1. My sleep quality was,Auto,18961837,Closed,systemuser,15 Feb 2026 12:13:05:113,systemuser,15 Feb 2026 12:15:12:553,systemuser,15 Feb 2026 12:15:12:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.113,20260215 12:15:12.553,20260215 12:15:12.553,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,2. My sleep was refreshing,Auto,18961838,Closed,systemuser,15 Feb 2026 12:13:05:120,systemuser,15 Feb 2026 12:15:12:553,systemuser,15 Feb 2026 12:15:12:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.120,20260215 12:15:12.553,20260215 12:15:12.553,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,3. I had a problem with my sleep,Auto,18961839,Closed,systemuser,15 Feb 2026 12:13:05:127,systemuser,15 Feb 2026 12:15:12:553,systemuser,15 Feb 2026 12:15:12:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.127,20260215 12:15:12.553,20260215 12:15:12.553,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,4. I had difficulty falling asleep,Auto,18961840,Closed,systemuser,15 Feb 2026 12:13:05:130,systemuser,15 Feb 2026 12:15:12:553,systemuser,15 Feb 2026 12:15:12:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.130,20260215 12:15:12.553,20260215 12:15:12.553,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,5. My sleep was restless,Auto,18961841,Closed,systemuser,15 Feb 2026 12:13:05:137,systemuser,15 Feb 2026 12:15:12:553,systemuser,15 Feb 2026 12:15:12:553,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.137,20260215 12:15:12.553,20260215 12:15:12.553,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,6. I tried hard to get to sleep,Auto,18961842,Closed,systemuser,15 Feb 2026 12:13:05:140,systemuser,15 Feb 2026 12:15:12:557,systemuser,15 Feb 2026 12:15:12:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.140,20260215 12:15:12.557,20260215 12:15:12.557,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,7. I worried about not being able to fall asleep,Auto,18961843,Closed,systemuser,15 Feb 2026 12:13:05:150,systemuser,15 Feb 2026 12:15:12:557,systemuser,15 Feb 2026 12:15:12:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.150,20260215 12:15:12.557,20260215 12:15:12.557,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,PROMIS - Sleep Disturbance,0/0/V,,8. I was satisfied with my sleep,Auto,18961844,Closed,systemuser,15 Feb 2026 12:13:05:153,systemuser,15 Feb 2026 12:15:12:557,systemuser,15 Feb 2026 12:15:12:557,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260215 12:13:05.153,20260215 12:15:12.557,20260215 12:15:12.557,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 3 Part 1 Baseline,Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,18986032,Closed,systemuser,17 Feb 2026 08:38:10:917,systemuser,17 Feb 2026 08:38:24:387,systemuser,17 Feb 2026 08:38:24:390,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260217 08:38:10.917,20260217 08:38:24.387,20260217 08:38:24.390,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 6 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19217488,Closed,systemuser,27 Feb 2026 17:25:44:183,systemuser,27 Feb 2026 17:25:50:500,systemuser,27 Feb 2026 17:25:50:500,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260227 17:25:44.183,20260227 17:25:50.500,20260227 17:25:50.500,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 7 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19510038,Closed,systemuser,13 Mar 2026 14:06:35:677,systemuser,13 Mar 2026 14:32:07:207,systemuser,13 Mar 2026 14:32:07:210,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260313 14:06:35.677,20260313 14:32:07.207,20260313 14:32:07.210,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Amphetamine,Auto,19749524,Closed,systemuser,29 Mar 2026 11:02:40:420,systemuser,29 Mar 2026 11:03:06:833,systemuser,29 Mar 2026 11:03:06:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.420,20260329 11:03:06.833,20260329 11:03:06.833,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Barbiturate,Auto,19749525,Closed,systemuser,29 Mar 2026 11:02:40:427,systemuser,29 Mar 2026 11:03:06:833,systemuser,29 Mar 2026 11:03:06:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.427,20260329 11:03:06.833,20260329 11:03:06.833,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Benzodiazepine,Auto,19749526,Closed,systemuser,29 Mar 2026 11:02:40:433,systemuser,29 Mar 2026 11:03:06:833,systemuser,29 Mar 2026 11:03:06:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.433,20260329 11:03:06.833,20260329 11:03:06.833,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cannabinoids,Auto,19749527,Closed,systemuser,29 Mar 2026 11:02:40:437,systemuser,29 Mar 2026 11:03:06:833,systemuser,29 Mar 2026 11:03:06:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.437,20260329 11:03:06.833,20260329 11:03:06.833,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Cocaine,Auto,19749528,Closed,systemuser,29 Mar 2026 11:02:40:443,systemuser,29 Mar 2026 11:03:06:833,systemuser,29 Mar 2026 11:03:06:833,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.443,20260329 11:03:06.833,20260329 11:03:06.833,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Collection Time,Auto,19749523,Closed,systemuser,29 Mar 2026 11:02:40:417,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.417,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,MDMA (Ecstasy),Auto,19749529,Closed,systemuser,29 Mar 2026 11:02:40:450,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.450,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methamphetamine,Auto,19749531,Closed,systemuser,29 Mar 2026 11:02:40:460,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.460,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Methadone,Auto,19749530,Closed,systemuser,29 Mar 2026 11:02:40:453,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.453,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Opiate,Auto,19749532,Closed,systemuser,29 Mar 2026 11:02:40:463,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.463,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Drug Testing,0/0/N,,Was the collection date the same as the visit date?,Auto,19749522,Closed,systemuser,29 Mar 2026 11:02:40:407,systemuser,29 Mar 2026 11:03:06:853,systemuser,29 Mar 2026 11:03:06:853,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:02:40.407,20260329 11:03:06.853,20260329 11:03:06.853,48,335,335,22,100,713,713
CZE,S10-CZ10012,Neuropsychiatrie Petrska sro,CZ100120006,Enrolled,Visit 8 Part 1 (1),Vital Signs,0/0/N,,Temperature Anatomical Location,Auto,19749521,Closed,systemuser,29 Mar 2026 11:01:39:253,systemuser,29 Mar 2026 11:01:57:367,systemuser,29 Mar 2026 11:01:57:367,,0,0,Required field.  Please complete or provide a response.,Value changed.,42847922MDD3003 [Prod],CZE,All,All,All,None,All,All,All,All,All,No,None,None,None,None,None,Final,With Text,5.6 - 1.0,5/21/2026 1:54:26 PM,GMT,Vladimir Buzalka [Site Manager],,20260329 11:01:39.253,20260329 11:01:57.367,20260329 11:01:57.367,48,335,335,22,100,713,713
