This template shows all ODM v2.0 elements and attributes, including those that are optional. XML files would typically not include attributes with an empty string as value. Empty elements can sometimes have meaning. For example, An empty MethodSignature may be used to explicitly indicate that the method does not take any input parameters or return any values.
Attributes and elements within the <xhtml:div> element are not displayed in this template.
ODM v2.0 Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM
xmlns="http://www.cdisc.org/ns/odm/v2.0"
xmlns:xhtml="http://www.w3.org/1999/xhtml"
xmlns:xlink="http://www.w3.org/1999/xlink"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
FileType=""
Granularity=""
Context=""
FileOID=""
CreationDateTime="2023-08-23T00:00:00"
PriorFileOID=""
AsOfDateTime="2023-08-23T00:00:00"
ODMVersion="2.0"
Originator="CDISC Data Exchange Standards ODM v2.0 Team"
SourceSystem=""
SourceSystemVersion="">
<Description>
<TranslatedText xml:lang="" Type="">
<xhtml:div>CDISC ODM v2.0 Template</xhtml:div>
</TranslatedText>
</Description>
<Study OID="" StudyName="" ProtocolName="" VersionId="" VersionName="" Status="">
<Description>
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<MetaDataVersion OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
<Standards>
<Standard OID="" Name="" Type="" PublishingSet="" Version="" Status="Draft" CommentOID=""> </Standard>
</Standards>
<AnnotatedCRF>
<DocumentRef LeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</AnnotatedCRF>
<SupplementalDoc>
<DocumentRef LeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</SupplementalDoc>
<ValueListDef OID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
<Origin Type="" Source=""> </Origin>
<WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
</ItemRef>
</ValueListDef>
<WhereClauseDef OID="" CommentOID="">
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<CheckValue/>
<!--
<MethodSignature> </MethodSignature>
<FormalExpression Context="">
<Code></Code>
</FormalExpression>
-->
<ErrorMessage>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</ErrorMessage>
</RangeCheck>
</WhereClauseDef>
<Protocol>
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<StudySummary>
<StudyParameter OID="" Term="" ShortName="">
<ParameterValue Value="">
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</ParameterValue>
</StudyParameter>
</StudySummary>
<StudyStructure>
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Arm OID="" Name="">
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
<WorkflowRef WorkflowOID=""/>
</Arm>
<Epoch OID="" Name="" SequenceNumber="">
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
</StudyStructure>
<TrialPhase Value="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
</TrialPhase>
<StudyTimings>
<StudyTiming OID="" Name="">
<AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID=""
StudyEventOID="" TimepointTarget="" TimepointPreWindow=""
TimepointPostWindow=""/>
<RelativeTimingConstraint OID="" Name="" Type="" PredecessorOID=""
SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow=""
TimepointPostWindow=""/>
<TransitionTimingConstraint OID="" Name="" TransitionOID="" MethodOID=""
Type="" TimepointPostWindow="" TimepointPreWindow="" TimepointTarget=""/>
<DurationTimingConstraint OID="" Name="" DurationPostWindow=""
DurationPreWindow="" DurationTarget="" StructuralElementOID=""/>
</StudyTiming>
</StudyTimings>
<StudyIndications>
<StudyIndication OID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</StudyIndication>
</StudyIndications>
<StudyInterventions>
<StudyIntervention OID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</StudyIntervention>
</StudyInterventions>
<StudyObjectives>
<StudyObjective OID="" Name="" Type="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
</StudyObjective>
</StudyObjectives>
<StudyEndPoints>
<StudyEndPoint OID="" Name="" Type="" Level="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<FormalExpression Context="">
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</FormalExpression>
</StudyEndPoint>
</StudyEndPoints>
<StudyTargetPopulation OID="" Name="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<FormalExpression Context="">
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</FormalExpression>
</StudyTargetPopulation>
<StudyEstimands>
<StudyEstimand OID="" Name="">
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
<StudyInterventionRef StudyInterventionOID=""/>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
<IntercurrentEvent>
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
</IntercurrentEvent>
<SummaryMeasure>
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
</SummaryMeasure>
</StudyEstimand>
</StudyEstimands>
<InclusionExclusionCriteria>
<InclusionCriteria>
<Criterion OID="" Name="" ConditionOID="">
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
</Criterion>
</InclusionCriteria>
<ExclusionCriteria>
<Criterion OID="" Name="" ConditionOID="">
<Description>
<TranslatedText xml:lang="" Type=""/>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
</Criterion>
</ExclusionCriteria>
</InclusionExclusionCriteria>
<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
</StudyEventGroupRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Alias Context="" Name=""> </Alias>
</Protocol>
<WorkflowDef OID="" Name="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<WorkflowStart StartOID=""> </WorkflowStart>
<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID=""
EndConditionOID=""> </Transition>
<Branching OID="" Name="" Type="">
<TargetTransition TargetTransitionOID="" ConditionOID=""> </TargetTransition>
<DefaultTransition TargetTransitionOID=""> </DefaultTransition>
</Branching>
<WorkflowEnd EndOID=""/>
</WorkflowDef>
<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
</StudyEventGroupRef>
<StudyEventRef StudyEventOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID=""> </StudyEventRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
</StudyEventGroupDef>
<StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID=""> </ItemGroupRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</StudyEventDef>
<ItemGroupDef OID="" Name="" Repeating="" RepeatingLimit="" IsReferenceData=""
Structure="" ArchiveLocationID="" DatasetName="" Domain="" Type="" Purpose=""
StandardOID="" IsNonStandard="" HasNoData="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Class Name="">
<SubClass Name="" ParentClass=""/>
</Class>
<ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID=""> </ItemGroupRef>
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
<Origin Type="" Source=""> </Origin>
<WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
</ItemRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Origin Type="" Source="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<SourceItems>
<SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID=""
LeafID="" Name="">
<Resource Type="" Name="" Attribute="" Label="">
<Selection Path=""/>
</Resource>
</SourceItem>
</SourceItems>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<DocumentRef LeafID=""> </DocumentRef>
</Origin>
<Alias Context="" Name=""> </Alias>
<Leaf ID="" xlink:href="">
<Title> </Title>
</Leaf>
</ItemGroupDef>
<ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Question>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Question>
<Prompt>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Prompt>
<CRFCompletionInstructions >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</CRFCompletionInstructions >
<ImplementationNotes >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</ImplementationNotes >
<Definition>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Definition>
<VariableSet >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</VariableSet >
<CDISCNotes >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</CDISCNotes >
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<CheckValue/>
<!--
<MethodSignature>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
</FormalExpression>
-->
<ErrorMessage>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</ErrorMessage>
</RangeCheck>
<CodeListRef CodeListOID=""> </CodeListRef>
<ValueListRef ValueListOID=""> </ValueListRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</ItemDef>
<CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue=""
CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<Decode>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Decode>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</CodeListItem>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</CodeList>
<ConditionDef OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</FormalExpression>
<Alias Context="" Name=""> </Alias>
</ConditionDef>
<MethodDef OID="" Name="" Type="" CommentOID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<MethodSignature>
<Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</FormalExpression>
<Alias Context="" Name=""> </Alias>
<DocumentRef LeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</MethodDef>
<CommentDef OID="">
<Description>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<DocumentRef LeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</CommentDef>
<Leaf ID="" xlink:href="">
<title> </title>
</Leaf>
</MetaDataVersion>
</Study>
<AdminData StudyOID="">
<User OID="" UserType="" OrganizationOID="" LocationOID="">
<UserName/>
<Prefix/>
<Suffix/>
<FullName/>
<GivenName/>
<FamilyName/>
<Image ImageFileName="" href="" MimeType=""> </Image>
<Address>
<StreetName/>
<HouseNumber/>
<City/>
<StateProv/>
<Country/>
<PostalCode/>
<GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
<OtherText/>
</Address>
<Telecom TelecomType="" Value=""> </Telecom>
</User>
<Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
<Description>
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<Address>
<StreetName/>
<HouseNumber/>
<City/>
<StateProv/>
<Country/>
<PostalCode/>
<GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
<OtherText/>
</Address>
<Telecom TelecomType="" Value=""> </Telecom>
</Organization>
<Location OID="" Name="" Role="" OrganizationOID="">
<Description>
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""> </MetaDataVersionRef>
<Address>
<StreetName/>
<HouseNumber/>
<City/>
<StateProv/>
<Country/>
<PostalCode/>
<GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
<OtherText/>
</Address>
<Telecom TelecomType="" Value=""> </Telecom>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
</Query>
</Location>
<SignatureDef OID="" Methodology="">
<Meaning/>
<LegalReason/>
</SignatureDef>
</AdminData>
<ReferenceData StudyOID="" MetaDataVersionOID="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
ItemGroupDataSeq="">
<ItemData ItemOID="" TransactionType="" IsNull="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID=""> </Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
</Query>
</ItemData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
</Query>
</ItemGroupData>
<ItemData ItemOID="" TransactionType="" IsNull="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
</Query>
</ItemData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</ReferenceData>
<ClinicalData StudyOID="" MetaDataVersionOID="">
<SubjectData SubjectKey="" TransactionType="">
<InvestigatorRef UserOID=""> </InvestigatorRef>
<SiteRef LocationOID=""> </SiteRef>
<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
ItemGroupDataSeq="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
ItemGroupDataSeq=""> </ItemGroupData>
<ItemData ItemOID="" TransactionType="" IsNull=""> </ItemData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID=""> </Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
</Query>
</StudyEventData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
</Query>
</SubjectData>
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
ItemGroupDataSeq="">
<ItemData ItemOID="" TransactionType="" IsNull="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID=""> </Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
</Query>
</ItemData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
</Query>
</ItemGroupData>
<ItemData ItemOID="" TransactionType="" IsNull="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
</AuditRecord>
</Query>
</ItemData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
</Query>
</ClinicalData>
<Association StudyOID="" MetaDataVersionOID="">
<KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
<KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
<Annotation SeqNum="" TransactionType="" ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" Type="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</Association>
</ODM>