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vladimir.buzalka
2026-06-01 15:38:22 +02:00
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Medidata/downloads/2026-05-20_15-21_EDC_MDD3003_QueryDetails.csv
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"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.","CZ100040006","Enrolled","Visit 8 Part 1 (1)","Date of Visit","0/1/N","","Did this visit occur?","DM","20915933","Answered","shyamaprasad972","19 May 2026 12:47:10:123","EHerman2","20 May 2026 12:02:23:567","","","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","Open,Answered","No","None","None","None","None","None","Final","With Text","5.6 - 1.0","5/20/2026 1:21:29 PM","GMT","Vladimir Buzalka [Site Manager]","","20260519 12:47:10.123","20260520 12:02:23.567","","1","4","4","1","1","4","4"
"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","","","","","1","","","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","Open,Answered","No","None","None","None","None","None","Final","With Text","5.6 - 1.0","5/20/2026 1:21:29 PM","GMT","Vladimir Buzalka [Site Manager]","","20260519 11:26:37.217","","","2","4","4","1","2","4","4"
"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","","","","","1","","","Please enter study drug administration start date as soon as it's available","","42847922MDD3003 [Prod]","CZE","All","All","All","None","All","All","All","All","Open,Answered","No","None","None","None","None","None","Final","With Text","5.6 - 1.0","5/20/2026 1:21:29 PM","GMT","Vladimir Buzalka [Site Manager]","","20260519 09:28:33.810","","","2","4","4","1","2","4","4"
"CZE","S10-CZ10012","Neuropsychiatrie Petrska sro","CZ100120005","Early Terminated","Investigator Periodic Review Acknowledgments/ Interim Signatures ","Periodic Investigator's EDC Review Acknowledgement","1/0/N","","As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.","Auto","20876096","Open","systemuser","17 May 2026 08:22:12:287","","","","","3","","","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.","","42847922MDD3003 [Prod]","CZE","All","All","All","None","All","All","All","All","Open,Answered","No","None","None","None","None","None","Final","With Text","5.6 - 1.0","5/20/2026 1:21:29 PM","GMT","Vladimir Buzalka [Site Manager]","","20260517 08:22:12.287","","","1","4","4","1","1","4","4"
1 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
2 CZE S10-CZ10004 Medical Services Prague s.r.o. CZ100040006 Enrolled Visit 8 Part 1 (1) Date of Visit 0/1/N Did this visit occur? DM 20915933 Answered shyamaprasad972 19 May 2026 12:47:10:123 EHerman2 20 May 2026 12:02:23:567 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 Open,Answered No None None None None None Final With Text 5.6 - 1.0 5/20/2026 1:21:29 PM GMT Vladimir Buzalka [Site Manager] 20260519 12:47:10.123 20260520 12:02:23.567 1 4 4 1 1 4 4
3 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 1 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 Open,Answered No None None None None None Final With Text 5.6 - 1.0 5/20/2026 1:21:29 PM GMT Vladimir Buzalka [Site Manager] 20260519 11:26:37.217 2 4 4 1 2 4 4
4 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 1 Please enter study drug administration start date as soon as it's available 42847922MDD3003 [Prod] CZE All All All None All All All All Open,Answered No None None None None None Final With Text 5.6 - 1.0 5/20/2026 1:21:29 PM GMT Vladimir Buzalka [Site Manager] 20260519 09:28:33.810 2 4 4 1 2 4 4
5 CZE S10-CZ10012 Neuropsychiatrie Petrska sro CZ100120005 Early Terminated Investigator Periodic Review Acknowledgments/ Interim Signatures Periodic Investigator's EDC Review Acknowledgement 1/0/N As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs. Auto 20876096 Open systemuser 17 May 2026 08:22:12:287 3 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. 42847922MDD3003 [Prod] CZE All All All None All All All All Open,Answered No None None None None None Final With Text 5.6 - 1.0 5/20/2026 1:21:29 PM GMT Vladimir Buzalka [Site Manager] 20260517 08:22:12.287 1 4 4 1 1 4 4