janssen/Medidata/downloads/2026-05-20_15-21_EDC_MDD3003_QueryDetails.csv

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