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: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="2022-10-11T00:00:00" PriorFileOID="" AsOfDateTime="2022-10-11T00:00:00" 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 Abstract Template</xhtml:div> </TranslatedText> </Description> <Study OID="" StudyName="" ProtocolName=""> <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=""> <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="" 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="" CommentOID=""/> </StudyIndication> </StudyIndications> <StudyInterventions> <StudyIntervention OID=""> <Description> <TranslatedText xml:lang="" type=""> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" 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=""> <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="" 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=""> </Criterion> </InclusionCriteria> <ExclusionCriteria> <Criterion OID="" Name="" ConditionOID=""> </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="" 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="" 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="ADAM OTHER"/> </Class> <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> </ItemGroupRef> <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> <Origin Type="" Source=""> </Origin> <WhereClauseRef WhereClauseOID=""> </WhereClauseRef> </ItemRef> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" 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="" 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> <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="" 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="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </CodeListItem> <!-- <EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue="" CommentOID=""> <Description> <TranslatedText xml:lang="" type=""> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </EnumeratedItem> --> <ExternalCodeList Dictionary="CDISC CT" Version="" href="" ref=""> </ExternalCodeList> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" 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="" 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="" 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="" 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="" 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="" 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="" 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="" 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="" 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="" 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="" 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="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> </Association> </ODM>