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<?xml version="1.0" encoding="UTF-8"?> <ODM FileType="Snapshot" Granularity="AllClinicalData" CreationDateTime="2021-03-10T13:36:51.668-00:00" FileOID="8ca17c08-5a6f-4fcb-bf82-b4fa46fe6d99" ODMVersion="2.0" xmlns="http://www.cdisc.org/ns/odm/v2.0"> <ClinicalData StudyOID="EX001" MetaDataVersionOID="1010"> <SubjectData SubjectKey="1001" TransactionType="Insert"> <SiteRef LocationOID="WestWing"/> <StudyEventData StudyEventOID="Visit1"> <ItemGroupData ItemGroupOID="VISDT" ItemGroupRepeatKey="1"> <ItemData ItemOID="VISDT"> <Value>2200-10-01</Value> <Query Source="System" Type="System" OID="A529A2F2-F896-4AF7-AD4D-11B7110727BC" State="Open" LastUpdateDatetime="2021-03-10T13:36:51.668-00:00" Name="VISDT_NOT_FUTURE"> <Value>Value 2200-10-01 is in the future, please correct</Value> <AuditRecord> <UserRef UserOID="SYSTEM"/> <LocationRef LocationOID="WestWing"/> <DateTimeStamp>2021-03-10T13:36:51.668-00:00</DateTimeStamp> </AuditRecord> </Query> </ItemData> </ItemGroupData> </StudyEventData> </SubjectData> </ClinicalData> </ODM> |
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<?xml version="1.0" encoding="UTF-8"?>
<ODM FileType="Snapshot" Granularity="AllClinicalData" CreationDateTime="2021-02-10T13:36:51.668-00:00" FileOID="8ca17c08-5a6f-4fcb-bf82-b4fa46fe6d99" ODMVersion="2.0" xmlns="http://www.cdisc.org/ns/odm/v2.0">
<ClinicalData StudyOID="EX001" MetaDataVersionOID="1010">
<SubjectData SubjectKey="1001" TransactionType="Insert">
<SiteRef LocationOID="WestWing"/>
<StudyEventData StudyEventOID="Visit1">
<ItemGroupData ItemGroupOID="VISDT" ItemGroupRepeatKey="1">
<ItemData ItemOID="VISDT">
<Value>2020-10-01</Value>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-14T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Entered 2020-10-01</ReasonForChange>
</AuditRecord>
<Query Source="System" Type="System" OID="A529A2F2-F896-4AF7-AD4D-11B7110727BC" State="Closed" LastUpdateDatetime="2021-03-10T13:36:51.668-00:00" Name="VISDT_NOT_FUTURE">
<Value>Value is in the future, please correct</Value>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-10T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check raised</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-12T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Reviewed</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-14T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Updated value to 2021-10-01 [Status Changed to "Answered"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-14T13:37:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check raised [Status Changed to "Open"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-16T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Reviewed</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-18T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Updated value to 2020-10-01 [Status Changed to "Answered"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-18T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check resolved by response [Status Changed to "Resolved"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-25T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check auto-closed [Status Changed to "Closed"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="INV01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-03-10T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Signed Subject CRF</ReasonForChange>
</AuditRecord>
</Query>
</ItemData>
</ItemGroupData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM> |