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"
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="" typeType="">
<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>
<Standards>
<Standard OID="" Name="" Type="" PublishingSet="" Version="" Status="Draft" CommentOID=""> </Standard>
</Standards>
<AnnotatedCRF>
<DocumentRef leafIDLeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</AnnotatedCRF>
<SupplementalDoc>
<DocumentRef leafIDLeafID="">
<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
</DocumentRef>
</SupplementalDoc>
<ValueListDef OID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </TranslatedText>
</ErrorMessage>
</RangeCheck>
</WhereClauseDef>
<Protocol>
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </TranslatedText>
</Description>
<Arm OID="" Name="">
<Description>
<TranslatedText xml:lang="" typeType=""/>
</Description>
<WorkflowRef WorkflowOID=""/>
</Arm>
<Epoch OID="" Name="" SequenceNumber="">
<Description>
<TranslatedText xml:lang="" typeType=""/>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
</StudyStructure>
<TrialPhase Value="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</StudyIndication>
</StudyIndications>
<StudyInterventions>
<StudyIntervention OID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
</StudyIntervention>
</StudyInterventions>
<StudyObjectives>
<StudyObjective OID="" Name="" Type="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
</StudyObjective>
</StudyObjectives>
<StudyEndPoints>
<StudyEndPoint OID="" Name="" Type="" Level="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<FormalExpression Context="">
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</FormalExpression>
</StudyEndPoint>
</StudyEndPoints>
<StudyTargetPopulation OID="" Name="">
<Description>
<TranslatedText xml:lang="" typeType=""> </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="" typeType=""/>
</Description>
<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
<StudyInterventionRef StudyInterventionOID=""/>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
<IntercurrentEvent>
<Description>
<TranslatedText xml:lang="" typeType=""/>
</Description>
</IntercurrentEvent>
<SummaryMeasure>
<Description>
<TranslatedText xml:lang="" typeType=""/>
</Description>
</SummaryMeasure>
</StudyEstimand>
</StudyEstimands>
<InclusionExclusionCriteria>
<InclusionCriteria>
<Criterion OID="" Name="" ConditionOID=""> </Criterion>
</InclusionCriteria>
<Description>
<ExclusionCriteria>
<Criterion OID<TranslatedText xml:lang="" NameType="" ConditionOID=""> </Criterion>
/>
</ExclusionCriteria>
</InclusionExclusionCriteria>Description>
<Coding <StudyEventGroupRef StudyEventGroupOIDCode="" System="" SystemName="" OrderNumberSystemVersion="" MandatoryLabel=""
href="" CollectionExceptionConditionOIDref="" CommentOID=""> </Coding>
<Description>
</Criterion>
<TranslatedText xml:lang="" type=""> </TranslatedText>InclusionCriteria>
</Description><ExclusionCriteria>
</StudyEventGroupRef>
<WorkflowRef WorkflowOID<Criterion OID=""> </WorkflowRef>
<Alias Context Name="" NameConditionOID=""> </Alias>
</Protocol>
<WorkflowDef OID="" Name="">
<Description>
<Description>
<TranslatedText xml:lang="" typeType=""/> </TranslatedText>
</Description>
<WorkflowStart StartOID=""> </WorkflowStart></Description>
<Coding <Transition OIDCode="" System="" SystemName="" SystemVersion="" NameLabel="" SourceOIDhref="" TargetOIDref="" StartConditionOIDCommentOID=""> </Coding>
EndConditionOID=""> </Transition>Criterion>
</ExclusionCriteria>
<Branching OID="" Name="" Type="">
</InclusionExclusionCriteria>
<TargetTransition<StudyEventGroupRef TargetTransitionOIDStudyEventGroupOID="" ConditionOIDOrderNumber=""> </TargetTransition> Mandatory=""
<DefaultTransition TargetTransitionOIDCollectionExceptionConditionOID="">
</DefaultTransition>
</Branching>
<Description>
<WorkflowEnd EndOID=""/>
<TranslatedText xml:lang="" Type=""> </WorkflowDef>TranslatedText>
<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
</Description>
<Description>
</StudyEventGroupRef>
<TranslatedText xml:lang="" type<WorkflowRef WorkflowOID=""> </TranslatedText>WorkflowRef>
<Alias Context="" Name=""> </Description>Alias>
<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""</Protocol>
<WorkflowDef CollectionExceptionConditionOIDOID="" Name="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<WorkflowStart StartOID=""> </StudyEventGroupRef>WorkflowStart>
<Transition <StudyEventRef StudyEventOIDOID="" Name="" SourceOID="" OrderNumberTargetOID="" MandatoryStartConditionOID=""
CollectionExceptionConditionOIDEndConditionOID=""> </StudyEventRef>Transition>
<WorkflowRef<Branching WorkflowOIDOID=""> </WorkflowRef>
Name="" Type="">
<Coding<TargetTransition CodeTargetTransitionOID="" SystemConditionOID="" SystemName="" SystemVersion="" Label="" href="" CommentOID> </TargetTransition>
<DefaultTransition TargetTransitionOID=""> </Coding>DefaultTransition>
</StudyEventGroupDef>Branching>
<StudyEventDef OID <WorkflowEnd EndOID="" Name/>
</WorkflowDef>
<StudyEventGroupDef OID="" RepeatingName="" TypeArmOID="" CategoryEpochOID="" CommentOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<ItemGroupRef ItemGroupOID="" MethodOID<StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID="">
</ItemGroupRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
<Description>
<Coding Code <TranslatedText xml:lang="" System="" SystemName="" SystemVersion="" LabelType="" href="" CommentOID=""> </Coding>TranslatedText>
<Alias Context="" Name=""> </Alias>Description>
</StudyEventDef>StudyEventGroupRef>
<ItemGroupDef OID="" Name="" Repeating <StudyEventRef StudyEventOID="" RepeatingLimitOrderNumber="" IsReferenceDataMandatory=""
Structure CollectionExceptionConditionOID="" ArchiveLocationID="" DatasetName="" Domain="" Type="" Purpose=""> </StudyEventRef>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
StandardOID <Coding Code="" System="" IsNonStandardSystemName="" HasNoDataSystemVersion="" CommentOIDLabel="">
href="" ref="" CommentOID=""> </Coding>
<Description></StudyEventGroupDef>
<StudyEventDef OID="" Name="" Repeating="" <TranslatedText xml:langType="" Category="" typeCommentOID=""> </TranslatedText>
</Description><Description>
<Class Name="">
<SubClass Name<TranslatedText xml:lang="" ParentClassType=""ADAM> OTHER"</>TranslatedText>
</Class>Description>
<ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID=""> </ItemGroupRef>
<ItemRef<WorkflowRef ItemOIDWorkflowOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""> </WorkflowRef>
<Coding Code="" UnitsItemOIDSystem="" SystemName="" RepeatSystemVersion="" OtherLabel="" Rolehref="" RoleCodeListOIDref="" OrderNumberCommentOID=""> </Coding>
<Alias MandatoryContext="" CollectionExceptionConditionOIDName=""> </Alias>
</StudyEventDef>
<Origin <ItemGroupDef TypeOID="" SourceName=""> </Origin>
<WhereClauseRef WhereClauseOID=""> </WhereClauseRef> Repeating="" RepeatingLimit="" IsReferenceData=""
</ItemRef>
<Coding CodeStructure="" SystemArchiveLocationID="" SystemNameDatasetName="" SystemVersionDomain="" LabelType="" hrefPurpose="" CommentOID=""> </Coding>
<WorkflowRef WorkflowOIDStandardOID="" IsNonStandard=""> </WorkflowRef>
<Origin Type HasNoData="" SourceCommentOID="">
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
<SourceItems><Class Name="">
<SourceItem ItemOID<SubClass Name="" ItemGroupOIDParentClass="" MetaDataVersionOID="" StudyOID=""
/>
</Class>
<ItemGroupRef leafIDItemGroupOID="" MethodOID="" OrderNumber="" NameMandatory="">
CollectionExceptionConditionOID=""> </ItemGroupRef>
<ItemRef <Resource TypeItemOID="" KeySequence="" NameIsNonStandard="" AttributeHasNoData="" LabelMethodOID="">
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
<Selection PathMandatory=""/>
CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
<Origin Type="" Source=""> </Resource>Origin>
<WhereClauseRef WhereClauseOID=""> </SourceItem>WhereClauseRef>
</SourceItems>ItemRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOIDref=""> CommentOID=""> </Coding>
<DocumentRef leafID<WorkflowRef WorkflowOID=""> </DocumentRef>WorkflowRef>
</Origin><Origin Type="" Source="">
<Alias Context="" Name=""> </Alias>
<Description>
<leaf<TranslatedText IDxml:lang="" xlink:hrefType=""> </TranslatedText>
<title> </title>Description>
</leaf>
<SourceItems>
</ItemGroupDef>
<ItemDef OID="" Name="" DataType <SourceItem ItemOID="" LengthItemGroupOID="" DisplayFormatMetaDataVersionOID="" CommentOIDStudyOID="">
<Description>
<TranslatedText xml:langLeafID="" typeName=""> </TranslatedText>
</Description>
<Resource Type="" Name="" <Question>Attribute="" Label="">
<TranslatedText xml:lang="" type <Selection Path=""/> </TranslatedText>
</Question>
</Resource>
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<CheckValue</>SourceItem>
<!--/SourceItems>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
<MethodSignature>
<DocumentRef LeafID=""> </DocumentRef>
</MethodSignature>Origin>
<Alias Context="" Name=""> </Alias>
<FormalExpression Context="">
<Leaf ID="" xlink:href="">
<Code></Code>
<Title> </Title>
</FormalExpression>Leaf>
</ItemGroupDef>
-->
<ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
<ErrorMessage>
<Description>
<TranslatedText xml:lang="" typeType=""> </TranslatedText>
</Description>
</ErrorMessage>
<Question>
</RangeCheck>
<CodeListRef CodeListOID<TranslatedText xml:lang="" Type=""> </CodeListRef>TranslatedText>
<ValueListRef ValueListOID=""> </ValueListRef>Question>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""> </Coding>
<Prompt>
<Alias Context<TranslatedText xml:lang="" NameType=""> </Alias>TranslatedText>
</ItemDef>Prompt>
<CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard="" <CRFCompletionInstructions >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</CRFCompletionInstructions >
<ImplementationNotes >
<TranslatedText xml:lang="" Type=""> </TranslatedText>
</ImplementationNotes >
<Description><Definition>
<TranslatedText xml:lang="" typeType=""> </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></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="">
<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="" 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="">
<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>
</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="" 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>
<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>
|