<?xml version="1.0" encoding="UTF-8"?>
<ODM
xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xmlns:xlink="http://www.w3.org/1999/xlink"
xmlns="http://www.cdisc.org/ns/odm/v2.0"
xsi:schemaLocation=""
FileType=""
Granularity=""
Context=""
FileOID=""
CreationDateTime="20212022-0507-1311"
PriorFileOID=""
AsOfDateTime=""
ODMVersion="2.0-R1"
Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi"
SourceSystem=""
SourceSystemVersion=""
Description="CDISC ODM v2.0 Abstract Template"
ID="">
<Study OID="" StudyName="" ProtocolName="">
<Description>
<TranslatedText></TranslatedText>
</Description>
<MetaDataVersion OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""/>
<Protocol>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<StudyStructure>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Arm OID="" Name="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<WorkflowRef WorkflowOID=""/>
</Arm>
<Epoch OID="" Name="" SequenceNumber="" PlannedDuration="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""/>
</StudyStructure>
<StudySummary>
<!-- Draft Note 5/13/2021: Created https://jira.cdisc.org/browse/ODM2DEV-78 due to a reference to StudyParameters under https://wiki.cdisc.org/display/ODM2/ParameterValue which is not represented in the ODM v2.0 specification-->
<StudyParameter OID="" Term="" ShortName <StudyParameter OID="" Term="" ShortName="">
<ParameterValue Value="">
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</ParameterValue>
</StudyParameter>
</StudySummary>
<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</StudyEventGroupRef>
<StudyTimings>
<StudyTiming OID="" Name="">
<TransitionTimingConstraint OID="" Name="" TransitionOID="" TimepointTarget="" MethodOID="" Type="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</TransitionTimingConstraint>
<AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID="" StudyEventOID="" TimepointTarget="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</AbsoluteTimingConstraint>
<DurationTimingConstraint OID="" Name="" StruturalElementOID="" DurationTarget="" DurationPreWindow="" DurationPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</DurationTimingConstraint>
<RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" TimepointRelativeTarget="" Type="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</RelativeTimingConstraint>
</StudyTiming>
</StudyTimings>
<StudyEndPoints>
<StudyEndPoint OID="" Name="" Type="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
<StudyInterventionRef StudyInterventionOID=""/>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
<InterCurrentEvent>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</InterCurrentEvent>
<SummaryMeasure>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</SummaryMeasure>
</StudyEndPoint>
</StudyEndPoints>
<StudyEstimands>
<StudyEstimand OID="" Name="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<FormalExpression Context="">
<ParameterValue Value=""> <Code></Code>
<Coding<ExternalCodeLib CodeLibrary="" SystemMethod="" SystemNameVersion="" SystemVersionref="" href="" CommentOID=""/>
</ParameterValue>FormalExpression>
</StudyParameter>StudyEstimand>
</StudySummary>StudyEstimands>
<StudyObjectives>
<StudyEventGroupRef <StudyObjective StudyEventGroupOIDOID="" MandatoryName="" OrderNumber="" CollectionExceptionConditionOIDType="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</StudyEventGroupRef>
<StudyTiming OID="" Name="">
<TransitionTimingConstraint OID="" Name="" TransitionOID<StudyEndPointRef StudyEndPointOID="" TimepointTargetOrderNumber="" MethodOID="" TimepointPreWindow/>
</StudyObjective>
</StudyObjectives>
<StudyTargetPopulation OID="" TimepointPostWindowName="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</TransitionTimingConstraint>
<AbsoluteTimingConstraint OID<Coding Code="" NameSystem="" StudyEventGroupOIDSystemName="" StudyEventOID="" TimepointTarget="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:langSystemVersion="" href="" typeCommentOID=""></TranslatedText>>
</Description>
<FormalExpression Context="">
<<Code></AbsoluteTimingConstraint> Code>
<DurationTimingConstraint<ExternalCodeLib OIDLibrary="" NameMethod="" StruturalElementOIDVersion="" DurationTargetref="" DurationPreWindowhref=""/>
<RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" RelativeTimepointTarget="" Type</FormalExpression>
</StudyTargetPopulation>
<InclusionExclusionCriteria>
<InclusionCriteria>
<Criterion OID="" TimepointPreWindowName="" TimepointPostWindowConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</RelativeTimingConstraint> Criterion>
</StudyTiming>InclusionCriteria>
</Protocol><ExclusionCriteria>
<WorkflowDef <Criterion OID="" Name="" ConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<WorkflowStart StartOID=""/>
<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/> </Criterion>
</ExclusionCriteria>
</InclusionExclusionCriteria>
<Branching<TrialPhase OIDValue="" Name="" Type="">
<TargetTransition TargetTransitionOID="" ConditionOID=""/><Description>
<DefaultTransition TargetTransitionOID <TranslatedText xml:lang="" type=""></>TranslatedText>
</Branching>Description>
<WorkflowEnd EndOID=""/></TrialPhase>
</WorkflowDef>Protocol>
<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID<WorkflowDef OID="" CommentOIDName="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<WorkflowStart StartOID=""/>
<StudyEventGroupRef StudyEventGroupOID<Transition OID="" Name="" SourceOID="" MandatoryTargetOID="" OrderNumberStartConditionOID="" CollectionExceptionConditionOIDEndConditionOID=""/>
<StudyEventRef StudyEventOID<Branching OID="" Name="" MandatoryType="" OrderNumber>
<TargetTransition TargetTransitionOID="" CollectionExceptionConditionOIDConditionOID=""/>
<WorkflowRef<DefaultTransition WorkflowOIDTargetTransitionOID=""/>
</Branching>
<Coding Code="" System<WorkflowEnd EndOID=""/>
</WorkflowDef>
<StudyEventGroupDef OID="" SystemNameName="" SystemVersionArmOID="" hrefEpochOID="" CommentOID=""/>
</StudyEventGroupDef><Description>
<StudyEventDef<TranslatedText OIDxml:lang="" Nametype="" Repeating></TranslatedText>
</Description>
<StudyEventGroupRef StudyEventGroupOID="" TypeMandatory="" CategoryOrderNumber="" CommentOIDCollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/></StudyEventGroupRef>
<ItemGroupRef<StudyEventRef ItemGroupOIDStudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<WorkflowRef WorkflowOID=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</StudyEventDef>StudyEventGroupDef>
<ItemGroupDef OID="" Name="" Repeating="" IsReferenceData <StudyEventDef OID="" DatasetNameName="" DomainRepeating="" Type="" PurposeCategory="" CommentOID="" MethodOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<ItemRef<WorkflowRef ItemOIDWorkflowOID="" Mandatory/>
<Coding Code="" OrderNumberSystem="" KeySequenceSystemName="" MethodOID="" UnitsItemOID="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
<Origin Type="" SourceType="">
<Description>
<TranslatedText xml:langSystemVersion="" href="" typeCommentOID=""></TranslatedText>>
</Description>StudyEventDef>
<Source>
<SourceItem ItemOID<ItemGroupDef OID="" Name="" Repeating="" ItemGroupOIDIsReferenceData="" leafIDDatasetName="" LabelDomain="">
<Resource Type="" NamePurpose="" CommentOID="" AttributeMethodOID="">
<Description>
<Selection<TranslatedText Pathxml:lang=""/>
</Resource>
</SourceItem>
type=""></TranslatedText>
</Source>Description>
</Origin><Alias Context="" Name=""/>
</ItemRef><ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<Coding Code<ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" SystemMethodOID="" SystemNameUnitsItemOID="" SystemVersionRepeat="" hrefOther="" CommentOIDRole=""/>
<WorkflowRef WorkflowOID RoleCodeListOID="" CollectionExceptionConditionOID=""/>
<Origin Type="" SourceTypeSource="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Source>
<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
<Resource Type="" Name="" Attribute="">
<Selection Path=""/>
</Resource>
</SourceItem>
</Source>
</Origin>
</ItemGroupDef>ItemRef>
<ItemDef OID<Coding Code="" System="" NameSystemName="" DataTypeSystemVersion="" Lengthhref="" CommentOID=""/>
<WorkflowRef WorkflowOID=""/>
<Origin Type="" Source="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<Source>
<Coding Code<SourceItem ItemOID="" ItemGroupOID="" SystemleafID="" SystemNameLabel="" SystemVersion>
<Resource Type="" hrefName="" CommentOIDAttribute=""/>
<WorkflowRef<Selection WorkflowOIDPath=""/>
<Question> </Resource>
</SourceItem>
<TranslatedText xml:lang="" type=""></TranslatedText></Source>
</Question>Origin>
</ItemGroupDef>
<RangeCheck Comparator<ItemDef OID="" Name="" DataType="" SoftHardLength="" ItemOIDCommentOID="">
<CheckValue></CheckValue>
<ErrorMessage>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</ErrorMessage>Description>
<MethodSignature><Alias Context="" Name=""/>
<Parameter Name<Coding Code="" System="" SystemName="" DataTypeSystemVersion="" Definitionhref="" OrderNumberCommentOID=""/>
<Question>
<ReturnValue Name="" DataType <TranslatedText xml:lang="" type=""></TranslatedText>
</Question>
<RangeCheck Comparator="" DefinitionSoftHard="" OrderNumberItemOID="">
<CheckValue></CheckValue>
<ErrorMessage>
<Parameter Name <TranslatedText xml:lang="" DataTypetype="" Definition="" OrderNumber=""/>
></TranslatedText>
</ErrorMessage>
<MethodSignature>
<ReturnValue <Parameter Name="" DataType="" Definition="" OrderNumber="">
<!-- Repeating -->
</ReturnValue>/>
</ReturnValue><ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</RangeCheck>
<CodeListRef CodeListOID=""/>
</ItemDef>
<CodeList OID="" Name="" DataType="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID="">
<Decode>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Decode>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<Alias Context="" Name=""/>
</CodeListItem>
<EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID="">
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</EnumeratedItem>
<!-- Draft Note: Create https://jira.cdisc.org/browse/ODM2DEV-80 to recommend adding a CommentOID attribute to ExternalCodeList -->
<ExternalCodeList Dictionary="" Version="" ref="" href=""/>
</CodeList>
<MethodDef<ConditionDef OID="" Name="" Type="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
<!-- Repeating -->
</ReturnValue>
</ReturnValue>="" Definition="" OrderNumber=""/>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</MethodDef>ConditionDef>
<ConditionDef<MethodDef OID="" Name="" Type="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
<!-- Repeating -->
</ReturnValue>
</ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</ConditionDef>MethodDef>
<CommentDef OID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</CommentDef>
</MetaDataVersion>
</Study>
<AdminData StudyOID="">
<User OID="" UserType="" OrganizationOID="" LocationOID="">
<UserName></UserName>
<Prefix></Prefix>
<Suffix></Suffix>
<FullName></FullName>
<GivenName></GivenName>
<FamilyName></FamilyName>
<Image ImageFileName="" href="" MimeType=""/>
<Address>
<HouseNumber></HouseNumber>
<StreetName></StreetName>
<City></City>
<StateProv></StateProv>
<Country></Country>
<PostalCode></PostalCode>
<OtherText></OtherText>
<GeoPosition Longitude="" Latitude="" Altitude=""/>
</Address>
<Telecom TelecomType="" Value=""/>
</User>
<Location OID="" Name="" Role="" OrganizationOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""/>
<Address>
<HouseNumber></HouseNumber>
<StreetName></StreetName>
<City></City>
<StateProv></StateProv>
<Country></Country>
<PostalCode></PostalCode>
<OtherText></OtherText>
<GeoPosition Longitude="" Latitude="" Altitude=""/>
</Address>
<Telecom TelecomType="" Value=""/>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
</Location>
<Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Address>
<HouseNumber></HouseNumber>
<StreetName></StreetName>
<City></City>
<StateProv></StateProv>
<Country></Country>
<PostalCode></PostalCode>
<OtherText></OtherText>
<GeoPosition Longitude="" Latitude="" Altitude=""/>
</Address>
<Telecom TelecomType="" Value=""/>
</Organization>
<SignatureDef OID="" Methodology="">
<Meaning></Meaning>
<LegalReason></LegalReason>
</SignatureDef>
</AdminData>
<ReferenceData StudyOID="" MetaDataVersionOID="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<ItemData ItemOID="" TransactionType="" IsNull="">
<Value SeqNum=""></Value>
<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Flag>
<FlagValue CodeListOID<Coding Code=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</ItemData>
<Query OID System="" SystemName="" SourceSystemVersion="" Targethref="" TypeCommentOID="" LastUpdateDatetime="" Name="">
/>
<Flag>
<Value <FlagValue SeqNumCodeListOID=""></Value>>
<AuditRecord<FlagType EditPointCodeListOID="" UsedMethod=""/>
<DateTimeStamp><</DateTimeStamp>Flag>
<ReasonForChange><</ReasonForChange>Annotation>
<SourceID></SourceID></ItemData>
<UserRef UserOID<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""/>
<LocationRef<Value LocationOIDSeqNum=""></>Value>
</AuditRecord>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedImputationMethod="" IDUsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID</Query>
</ItemGroupData>
</ReferenceData>
<ClinicalData StudyOID="" MetaDataVersionOID="">
<SignatureRef SignatureOID<Annotation SeqNum="" TransactionType=""/>
<DateTimeStamp><<Comment></DateTimeStamp>Comment>
<UserRef UserOID<Coding Code="" System=""/>
<LocationRef LocationOID SystemName=""/>
</Signature>
<Annotation SeqNum SystemVersion="" TransactionTypehref="" IDCommentOID=""/>
<AnnotationValue><Flag>
<TranslatedText<FlagValue xml:langCodeListOID="" type/>
<FlagType CodeListOID=""></TranslatedText>>
</AnnotationValue>Flag>
</Annotation>
<Comment SponsorOrSite<AuditRecord EditPoint="" UsedMethod="">
<TranslatedText xml:lang="" type=""></TranslatedText><DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<<SourceID></Comment>SourceID>
<Flag> <UserRef UserOID=""/>
<FlagValue<LocationRef CodeListOIDLocationOID=""/>
</AuditRecord>
<FlagType CodeListOID<Signature>
<SignatureRef SignatureOID=""/>
<<DateTimeStamp></Flag>DateTimeStamp>
</Annotation>
</ReferenceData>
<ClinicalData StudyOID <UserRef UserOID="" MetaDataVersionOID/>
<LocationRef LocationOID=""/>
</Signature>
<SubjectData SubjectKey="" TransactionType="">
<AuditRecord EditPoint="" UsedImputationMethodUsedMethod="" ID="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID=""><Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation<InvestigatorRef SeqNumUserOID="" TransactionType="" ID=""/>
<AnnotationValue> <SiteRef LocationOID=""/>
<TranslatedText xml:lang<Annotation SeqNum="" typeTransactionType=""></TranslatedText>>
<<Comment></AnnotationValue>Comment>
<Comment SponsorOrSite<Coding Code="" System="" SystemName="">
<TranslatedText xml:lang SystemVersion="" href="" typeCommentOID=""></TranslatedText>>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
<InvestigatorRef UserOID=""/>
<SiteRef LocationOID=""/>
<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">/Query>
<ItemGroupData<StudyEventData ItemGroupOIDStudyEventOID="" ItemGroupRepeatKeyStudyEventRepeatKey="" TransactionType="" ItemGroupDataSeq="">
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</Flag>
<Flag>
</Annotation>
<FlagValue CodeListOID=""/>
<ItemData<FlagType ItemOIDCodeListOID="" TransactionType="" IsNull=""/>
<Value SeqNum=""></Value>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagValue <FlagType CodeListOID=""/>
</Flag>
</Annotation>
<FlagType CodeListOID<ItemData ItemOID="" TransactionType="" IsNull=""/>
</Flag>
</Annotation>
<Value SeqNum=""></Value>
</ItemData>
<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedImputationMethod="" IDUsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID="">
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue> <Comment></Comment>
<TranslatedText<Coding xml:langCode="" typeSystem=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite SystemName="">
<TranslatedText xml:lang SystemVersion="" href="" typeCommentOID=""></TranslatedText>>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
Annotation>
</ItemData>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
</ItemGroupData>
</StudyEventData>
</SubjectData>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
</ClinicalData>
<Association StudyOID="" MetaDataVersionOID="">
<KeySet StudyOID="" SubjectKey="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""/>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue> <Comment></Comment>
<TranslatedText xml:lang<Coding Code="" typeSystem=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite SystemName="">
<TranslatedText xml:lang SystemVersion="" href="" typeCommentOID=""></TranslatedText>
</Comment>/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</Association>
<ds:Signature xmlns="http://www.w3.org/2000/09/xmldsig#" Id="1">
<SignedInfo></SignedInfo>
<SignatureValue></SignatureValue>
<KeyInfo></KeyInfo>
<Object></Object>
</ds:Signature>
</ODM> |