Under development
Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM
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="2022-07-11"
PriorFileOID=""
AsOfDateTime=""
ODMVersion="2.0-R1"
Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi"
SourceSystem=""
SourceSystemVersion="">
<Description>
<TranslatedText xml:lang="" type="">CDISC ODM v2.0 Abstract Template</TranslatedText>
</Description>
<Study OID="" StudyName="" ProtocolName="">
<Description>
<TranslatedText xml:lang="" type=""></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="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""/>
</StudyStructure>
<StudySummary>
<StudyParameter OID="" Term="" ShortName="">
<ParameterValue Value="">
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" 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>
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</Description>
</DurationTimingConstraint>
<RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" TimepointRelativeTarget="" Type="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
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</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>
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</StudyEndPoints>
<StudyEstimands>
<StudyEstimand OID="" Name="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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</StudyEstimand>
</StudyEstimands>
<StudyObjectives>
<StudyObjective OID="" Name="" Type="">
<Description>
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<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
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<StudyTargetPopulation OID="" Name="">
<Description>
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<Description>
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<ExclusionCriteria>
<Criterion OID="" Name="" ConditionOID="">
<Description>
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<TrialPhase Value="">
<Description>
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</TrialPhase>
</Protocol>
<WorkflowDef OID="" Name="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<WorkflowStart StartOID=""/>
<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/>
<Branching OID="" Name="" Type="">
<TargetTransition TargetTransitionOID="" ConditionOID=""/>
<DefaultTransition TargetTransitionOID=""/>
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<WorkflowEnd EndOID=""/>
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<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
<Description>
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<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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</StudyEventGroupRef>
<StudyEventRef StudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<WorkflowRef WorkflowOID=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
</StudyEventGroupDef>
<StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<WorkflowRef WorkflowOID=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
</StudyEventDef>
<ItemGroupDef OID="" Name="" Repeating="" IsReferenceData="" DatasetName="" Domain="" Type="" Purpose="" CommentOID="" MethodOID="">
<Description>
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<Alias Context="" Name=""/>
<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
<Origin Type="" Source="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<SourceItems>
<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
<Resource Type="" Name="" Attribute="">
<Selection Path=""/>
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<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<WorkflowRef WorkflowOID=""/>
<Origin Type="" Source="">
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<Description>
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<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<Question>
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</Question>
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<CheckValue></CheckValue>
<ErrorMessage>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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<CodeListRef CodeListOID=""/>
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<CodeList OID="" Name="" DataType="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID="">
<Decode>
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<EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID="">
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
</EnumeratedItem>
<ExternalCodeList Dictionary="" Version="" ref="" href=""/>
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<ConditionDef OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<Alias Context="" Name=""/>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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<MethodDef OID="" Name="" Type="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
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<Alias Context="" Name=""/>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
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<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="" Label="" 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>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</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>
</ReferenceData>
<ClinicalData StudyOID="" MetaDataVersionOID="">
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<SubjectData SubjectKey="" TransactionType="">
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<InvestigatorRef UserOID=""/>
<SiteRef LocationOID=""/>
<Annotation SeqNum="" TransactionType="">
<Comment></Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<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>
<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
<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="" Label="" href="" CommentOID=""/>
<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>
<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="" Label="" 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>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</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="">
<Comment></Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</Association>
</ODM>