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.
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<?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:nci="http://ncicb.nci.nih.gov/xml/odm/EVS/CDISC"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xsi:schemaLocation="http://www.cdisc.org/ns/odm/v2.0 file:/C:/_github/cdisc-org/DataExchange-ODM/schema/ODM.xsd-instance"
FileType=""
Granularity=""
Context=""
FileOID=""
CreationDateTime="20222023-1008-11T0023T00:00:00"
PriorFileOID=""
AsOfDateTime="20222023-1008-11T0023T00:00:00"
ODMVersion="2.0"
Originator="CDISC Data Exchange Standards ODM v2.0 Team"
SourceSystem=""
SourceSystemVersion="">
<Description>
<TranslatedText xml:lang="" typeType="">
<xhtml:div>CDISC ODM v2.0 Abstract 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="" typeType="">
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
<MetaDataVersion <Standards>
<Standard OID="" Name="" Type="" PublishingSet="" Version="" Status="Draft" CommentOID=""> </Standard>
<Description></Standards>
<AnnotatedCRF>
<TranslatedText xml:lang="" type <DocumentRef LeafID="">
<xhtml:div> </xhtml:div> <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</TranslatedText>DocumentRef>
</Description>AnnotatedCRF>
<SupplementalDoc>
<Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
<DocumentRef <Standards>
LeafID="">
<Standard OID="" Name<PDFPageRef PageRefs="" TypeFirstPage="" PublishingSetLastPage="" VersionType="" StatusTitle="Draft"/>
CommentOID=""> </Standard>DocumentRef>
</Standards>SupplementalDoc>
<AnnotatedCRF><ValueListDef OID="">
<DocumentRef leafID=""><Description>
<PDFPageRef<TranslatedText PageRefsxml:lang="" FirstPage="" LastPage="" Type=""> Title=""/></TranslatedText>
</DocumentRef>Description>
</AnnotatedCRF>
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
<SupplementalDoc>
UnitsItemOID="" Repeat="" Other="" Role="" <DocumentRef leafIDRoleCodeListOID="" OrderNumber="">
<PDFPageRef PageRefsMandatory="" FirstPageCollectionExceptionConditionOID="" LastPagePreSpecifiedValue="" TypeCore="" Title=""/>
</DocumentRef>
<Origin Type="" Source=""> </Origin>
</SupplementalDoc>
<ValueListDef<WhereClauseRef OIDWhereClauseOID=""> </WhereClauseRef>
<Description></ItemRef>
</ValueListDef>
<TranslatedText<WhereClauseDef xml:langOID="" typeCommentOID=""> </TranslatedText>
</Description>
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
<CheckValue/>
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber="" <!--
Mandatory="" CollectionExceptionConditionOID=""><MethodSignature> </MethodSignature>
<Origin<FormalExpression TypeContext="">
Source=""> </Origin>
<WhereClauseRef WhereClauseOID=""> <<Code></WhereClauseRef>Code>
</ItemRef>FormalExpression>
</ValueListDef>
-->
<WhereClauseDef OID="" CommentOID="">
<ErrorMessage>
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<TranslatedText xml:lang="" Type=""> <CheckValue</>TranslatedText>
<!-- /ErrorMessage>
</RangeCheck>
<MethodSignature>
</WhereClauseDef>
</MethodSignature><Protocol>
<FormalExpression Context=""><Description>
<TranslatedText xml:lang="" <Code></Code>
Type=""> </TranslatedText>
</FormalExpression>Description>
<StudySummary>
-->
<StudyParameter OID="" <ErrorMessage>Term="" ShortName="">
<TranslatedText xml:lang="" type<ParameterValue Value=""> </TranslatedText>
</ErrorMessage>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" </RangeCheck>ref="" CommentOID=""/>
</WhereClauseDef>
<Protocol></ParameterValue>
<Description>
</StudyParameter>
<TranslatedText xml:lang="" type=""> </TranslatedText>StudySummary>
</Description><StudyStructure>
<StudySummary>
<Description>
<StudyParameter OID="" Term="" ShortName="">
<TranslatedText xml:lang="" Type=""> </TranslatedText>
<ParameterValue Value="">
</Description>
<Coding Code="" System="" SystemName="" SystemVersion <Arm OID="" Label="" href="" CommentOIDName=""/>
</ParameterValue><Description>
</StudyParameter>
<TranslatedText </StudySummary>xml:lang="" Type=""/>
<StudyStructure>
<Description></Description>
<TranslatedText<WorkflowRef xml:langWorkflowOID="" type=""> </TranslatedText>/>
</Description>Arm>
<Arm<Epoch OID="" Name="" SequenceNumber="">
<Description>
<TranslatedText xml:lang="" typeType=""/>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""> </>WorkflowRef>
</Arm>
StudyStructure>
<Epoch OID="" Name="" SequenceNumber<TrialPhase Value="">
<Description>
<TranslatedText xml:lang="" typeType=""> </>TranslatedText>
</Description>
</Description>
</TrialPhase>
</Epoch><StudyTimings>
<StudyTiming <WorkflowRef WorkflowOIDOID="" Name=""> </WorkflowRef>
</StudyStructure>
<AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID=""
<TrialPhase Value="">
StudyEventOID="" <Description>TimepointTarget="" TimepointPreWindow=""
<TranslatedText xml:lang="" type TimepointPostWindow=""/> </TranslatedText>
<RelativeTimingConstraint </Description>
OID="" Name="" Type="" PredecessorOID=""
</TrialPhase>
SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow=""
<StudyTimings>
<StudyTiming OID="" NameTimepointPostWindow=""/>
<AbsoluteTimingConstraint<TransitionTimingConstraint OID="" Name="" StudyEventGroupOIDTransitionOID="" MethodOID=""
StudyEventOIDType="" TimepointTargetTimepointPostWindow="" TimepointPreWindow="" TimepointTarget=""/>
<DurationTimingConstraint OID="" TimepointPostWindowName="" DurationPostWindow=""/>
<RelativeTimingConstraint OID="" Name DurationPreWindow="" TypeDurationTarget="" PredecessorOIDStructuralElementOID=""/>
</StudyTiming>
SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow=""
</StudyTimings>
<StudyIndications>
TimepointPostWindow <StudyIndication OID=""/>
<TransitionTimingConstraint OID="" Name="" TransitionOID="" MethodOID=""<Description>
Type="" TimepointPostWindow<TranslatedText xml:lang="" TimepointPreWindowType=""> TimepointTarget=""/></TranslatedText>
<DurationTimingConstraint OID="" Name="" DurationPostWindow=""
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" DurationPreWindowLabel="" href="" DurationTargetref="" StructuralElementOIDCommentOID=""/>
</StudyTiming>StudyIndication>
</StudyTimings>StudyIndications>
<StudyIndications><StudyInterventions>
<StudyIndication<StudyIntervention OID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</StudyIndication>StudyIntervention>
</StudyIndications>StudyInterventions>
<StudyInterventions><StudyObjectives>
<StudyIntervention<StudyObjective OID="" Name="" Type="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<Coding<StudyEndPointRef CodeStudyEndPointOID="" System="" SystemNameOrderNumber="" SystemVersion="" Label="" href="" CommentOID=""/>
</StudyIntervention>StudyObjective>
</StudyInterventions>StudyObjectives>
<StudyObjectives><StudyEndPoints>
<StudyObjective<StudyEndPoint OID="" Name="" Type="" Level="">
<Description>
<TranslatedText xml:lang="" typeType="">> </TranslatedText>
</TranslatedText>Description>
</Description>
<FormalExpression Context="">
<StudyEndPointRef StudyEndPointOID="" OrderNumber="" <Code/>
</StudyObjective>
<!-- </StudyObjectives>
<StudyEndPoints>
<ExternalCodeLib <StudyEndPoint OIDLibrary="" Method="" Version="" Nameref="" Typehref=""/>
<Description>-->
</FormalExpression>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</StudyEndPoint>
</Description>
</StudyEndPoints>
<StudyTargetPopulation <FormalExpression ContextOID="" Name="">
<Description>
<Code/>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
<!-- </Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<ExternalCodeLib Library="" Method="" Version="" ref="" href <FormalExpression Context=""/>
--<Code/>
</FormalExpression>
!-- </StudyEndPoint>
</StudyEndPoints>
<ExternalCodeLib Library="" Method="" <StudyTargetPopulation OIDVersion="" ref="" Namehref=""/>
<Description> -->
</FormalExpression>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</StudyTargetPopulation>
</Description>
<StudyEstimands>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href <StudyEstimand OID="" CommentOIDName=""> </Coding>
<FormalExpression Context=""><Description>
<Code/>
<TranslatedText xml:lang="" Type=""/>
<!-- </Description>
<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
<ExternalCodeLib Library="" Method="" Version="" ref <StudyInterventionRef StudyInterventionOID="" href=""/>
--<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
</FormalExpression>
<IntercurrentEvent>
</StudyTargetPopulation>
<Description>
<StudyEstimands>
<StudyEstimand<TranslatedText OIDxml:lang="" NameType=""/>
<Description>
</Description>
</IntercurrentEvent>
<TranslatedText xml:lang="" type=""/>
<SummaryMeasure>
</Description>
<Description>
<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
<StudyInterventionRef StudyInterventionOID<TranslatedText xml:lang="" Type=""/>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/> </Description>
<IntercurrentEvent>
</SummaryMeasure>
</StudyEstimand>
<Description></StudyEstimands>
<InclusionExclusionCriteria>
<TranslatedText xml:lang="" type=""/> <InclusionCriteria>
<Criterion OID="" Name="" </Description>ConditionOID="">
</IntercurrentEvent>
<Description>
<SummaryMeasure>
<TranslatedText xml:lang="" Type=""/>
<Description>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" <TranslatedText xml:langLabel="" href="" ref="" typeCommentOID=""> </>Coding>
</Description>Criterion>
</SummaryMeasure>InclusionCriteria>
</StudyEstimand><ExclusionCriteria>
</StudyEstimands>
<Criterion OID="" Name="" ConditionOID="">
<InclusionExclusionCriteria>
<InclusionCriteria>
<Description>
<Criterion OID="" Name="" ConditionOID=""> </Criterion>
<TranslatedText xml:lang="" Type=""/>
</InclusionCriteria>
<ExclusionCriteria></Description>
<Coding Code="" System="" SystemName="" SystemVersion="" <Criterion OIDLabel="" href="" Nameref="" ConditionOIDCommentOID=""> </Criterion>
Coding>
</Criterion>
< </ExclusionCriteria>
</InclusionExclusionCriteria>
<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
</StudyEventGroupRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Alias Context="" Name=""> </Alias>
</Protocol>
<WorkflowDef OID="" Name="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </TranslatedText>
</Description>
<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </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="" typeType=""> </TranslatedText>
</Description>
<Class Name="">
<SubClass Name="" ParentClass="ADAM OTHER"/>
</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="" typeType=""> </TranslatedText>
</Description>
<SourceItems>
<SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID=""
leafIDLeafID="" Name="">
<Resource Type="" Name="" Attribute="" Label="">
<Selection Path=""/>
</Resource>
</SourceItem>
</SourceItems>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<DocumentRef leafIDLeafID=""> </DocumentRef>
</Origin>
<Alias Context="" Name=""> </Alias>
<leaf<Leaf ID="" xlink:href="">
<title><Title> </title>Title>
</leaf>Leaf>
</ItemGroupDef>
<ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<Question>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Question>
<Prompt>
<RangeCheck Comparator <TranslatedText xml:lang="" SoftHardType="" ItemOID=""> </TranslatedText>
</Prompt>
<CRFCompletionInstructions >
<TranslatedText xml:lang="" Type=""> <CheckValue</>TranslatedText>
</CRFCompletionInstructions >
<!-- <ImplementationNotes >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
<MethodSignature>
</ImplementationNotes >
</MethodSignature>
<Definition>
<TranslatedText <FormalExpression Contextxml:lang="" Type=""> </TranslatedText>
</Definition>
<Code></Code>
<VariableSet >
</FormalExpression>
<TranslatedText xml:lang="" Type=""> </TranslatedText>
-->
</VariableSet >
<CDISCNotes <ErrorMessage>>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</ErrorMessage>
</RangeCheck>
<CodeListRef CodeListOID</CDISCNotes >
<RangeCheck Comparator="" SoftHard="" ItemOID="">
</CodeListRef>
<ValueListRef ValueListOID=""> <<CheckValue/ValueListRef>>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""> </Coding>
<!--
<Alias Context="" Name=""> </Alias>
</ItemDef>
<MethodSignature>
<CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard="">
</MethodSignature>
<Description>
<TranslatedText xml:lang="" type <FormalExpression Context=""> </TranslatedText>
<<Code></Description>Code>
<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue="" </FormalExpression>
CommentOID=""-->
<Description><ErrorMessage>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>ErrorMessage>
<Decode></RangeCheck>
<TranslatedText xml:lang<CodeListRef CodeListOID="" type=""> </TranslatedText>CodeListRef>
<ValueListRef ValueListOID=""> </Decode>ValueListRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>Alias>
</ItemDef>
<CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard="">
</CodeListItem><Description>
<!-- <TranslatedText xml:lang="" Type=""> </TranslatedText>
</Description>
<EnumeratedItem <CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue=""
CommentOID="">
<Description>
<TranslatedText xml:lang="" typeType="">
</TranslatedText>
</TranslatedText>Description>
</Description><Decode>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href <TranslatedText xml:lang="" CommentOIDType=""> </Coding>TranslatedText>
</Decode>
<Alias Context="" Name=""> </Alias>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </EnumeratedItem>Coding>
-->
<Alias Context="" Name=""> </Alias>
<ExternalCodeList Dictionary="CDISC CT" Version="" href="" ref=""> </ExternalCodeList>CodeListItem>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</CodeList>
<ConditionDef OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </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 leafIDLeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</MethodDef>
<CommentDef OID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<DocumentRef leafIDLeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</CommentDef>
<leaf<Leaf ID="" xlink:href="">
<title> </title>
</leaf>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="" typeType="">
<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="" typeType="">
<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="" typeType=""> </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="" typeType=""> </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="" typeType=""> </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="" typeType="">
<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="">
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<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
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<Annotation SeqNum="" TransactionType="" ID=""> </Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
</Query>
</ItemGroupData>
<AuditRecord EditPoint="" UsedMethod="">
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<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="" typeType=""> </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="">
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<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
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</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/>
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<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
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<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="" typeType=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<Flag>
<FlagValue CodeListOID=""/>
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</Annotation>
<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
<Value SeqNum=""/>
<AuditRecord EditPoint="" UsedMethod="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<DateTimeStamp/>
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</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="" typeType=""> </TranslatedText>
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<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="" typeType=""> </TranslatedText>
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<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="" typeType="">
<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="" typeType="">
<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>
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