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.Under development
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<?xml version="1.0" encoding="UTF-8"?> <ODM xmlns:xsi xmlns="http://www.w3cdisc.org/ns/2001/XMLSchema-instanceodm/v2.0" xmlns:xlinkxhtml="http://www.w3.org/1999/xlinkxhtml" xmlns xmlns:xlink="http://www.cdiscw3.org/ns/odm/v2.0" xsi:schemaLocation="" 1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" FileType="" Granularity="" Context="" FileOID="" CreationDateTime="20222023-07-11" 08-23T00:00:00" PriorFileOID="" AsOfDateTime="2023-08-23T00:00:00" ODMVersion="2.0-R1" Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi" " SourceSystem="" SourceSystemVersion=""> <Description> <TranslatedText <TranslatedText xml:lang="" typeType="">CDISC> <xhtml:div>CDISC ODM v2.0 Abstract Template<Template</xhtml:div> </TranslatedText> </Description> <Study OID="" StudyName="" ProtocolName=""> <Description> <TranslatedText xml:lang VersionId="" typeVersionName=""></TranslatedText> </Description> <MetaDataVersion OID Status="" Name="" CommentOID=""> <Description> > <Description> <TranslatedText xml:lang="" typeType=""></TranslatedText> </Description> <Include StudyOID> <xhtml:div> </xhtml:div> </TranslatedText> </Description> <MetaDataVersion OID="" MetaDataVersionOIDName="" hrefCommentOID=""/> <Protocol> <Description> > <Description> <TranslatedText xml:lang="" typeType=""></TranslatedText> </Description> <Alias Context="" Name=""/> <StudyStructure> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Arm OID="" Name=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <WorkflowRef WorkflowOID=""/> </Arm> <Epoch OID="" Name="" SequenceNumber=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </Epoch> <WorkflowRef WorkflowOID=""/> </StudyStructure> <StudySummary> <StudyParameter OID="" Term="" ShortName=""> <ParameterValue Value=""> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> </ParameterValue> </StudyParameter> </StudySummary> <StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""> <Description> > <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="" typeType=""><> </TranslatedText> </Description> </StudyEventGroupRef> <StudyTimings> <StudyTiming OID </Description> <ItemRef ItemOID="" NameKeySequence=""> <TransitionTimingConstraint OID IsNonStandard="" NameHasNoData="" TransitionOIDMethodOID="" TimepointTarget UnitsItemOID="" MethodOIDRepeat="" TypeOther="" TimepointPreWindowRole="" TimepointPostWindowRoleCodeListOID=""> <Description> <TranslatedText xml:lang OrderNumber="" type=""></TranslatedText> </Description> </TransitionTimingConstraint> <AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID="" StudyEventOID Mandatory="" TimepointTargetCollectionExceptionConditionOID="" TimepointPreWindowPreSpecifiedValue="" TimepointPostWindowCore=""> <Description> <TranslatedText xml:lang <Origin Type="" typeSource=""></TranslatedText> > </Description> </AbsoluteTimingConstraint> <DurationTimingConstraintOrigin> <WhereClauseRef WhereClauseOID=""> </WhereClauseRef> </ItemRef> </ValueListDef> <WhereClauseDef OID="" NameCommentOID="" StruturalElementOID="" DurationTarget> <RangeCheck Comparator="" DurationPreWindowSoftHard="" DurationPostWindowItemOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </DurationTimingConstraint> <RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" TimepointRelativeTarget="" Type="" TimepointPreWindow="" TimepointPostWindow=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </RelativeTimingConstraint> </StudyTiming> </StudyTimings> <StudyEndPoints> <StudyEndPoint OID="" Name="" Type=""> <Description> <CheckValue/> <!-- <MethodSignature> </MethodSignature> <FormalExpression Context=""> <Code></Code> </FormalExpression> --> <ErrorMessage> <TranslatedText xml:lang="" typeType=""><> </TranslatedText> </Description> <StudyTargetPopulationRef StudyTargetPopulationOID=""/> <StudyInterventionRef StudyInterventionOID=""/> <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/> <InterCurrentEvent> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </InterCurrentEvent> <SummaryMeasure> <Description> </ErrorMessage> </RangeCheck> </WhereClauseDef> <Protocol> <Description> <TranslatedText xml:lang="" typeType=""><> </TranslatedText> </Description> </SummaryMeasure> </StudyEndPoint> </StudyEndPoints> <StudyEstimands> <StudyEstimand <StudySummary> <StudyParameter OID="" NameTerm=""> <Description> <TranslatedText xml:lang ShortName="" type=""></TranslatedText> </Description> <FormalExpression Context=""> <Code></Code> <ExternalCodeLib Library="" Method="" Version> <ParameterValue Value=""> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" hrefCommentOID=""/> </FormalExpression> </StudyEstimand> </StudyEstimands> <StudyObjectives> <StudyObjective OID="" Name="" Type=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/> </StudyObjective> </StudyObjectives> <StudyTargetPopulation OID="" Name=""> <Description> </ParameterValue> </StudyParameter> </StudySummary> <StudyStructure> <Description> <TranslatedText xml:lang="" typeType=""><> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" Label="" href="" CommentOID=""/> <FormalExpression Context=""> <Code></Code> <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> </FormalExpression> </StudyTargetPopulation> <InclusionExclusionCriteria> <InclusionCriteria> <Criterion OID="" Name="" ConditionOID=""> <Description> </Description> <Arm OID="" Name=""> <Description> <TranslatedText xml:lang="" typeType=""></TranslatedText> </Description> </Criterion> </InclusionCriteria> <ExclusionCriteria> <Criterion> </Description> <WorkflowRef WorkflowOID=""/> </Arm> <Epoch OID="" Name="" ConditionOIDSequenceNumber=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </Criterion> </ExclusionCriteria> </InclusionExclusionCriteria> <TrialPhase Value=""> <Description> <Description> <TranslatedText xml:lang="" typeType=""></TranslatedText> </Description> </TrialPhase> </Protocol> <WorkflowDef OID="" Name=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <WorkflowStart StartOID=""/> <Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/> <Branching OID="" Name> </Description> </Epoch> <WorkflowRef WorkflowOID=""> </WorkflowRef> </StudyStructure> <TrialPhase Value=""> <Description> <TranslatedText xml:lang="" Type=""> <TargetTransition TargetTransitionOID="" ConditionOID=""/> <DefaultTransition TargetTransitionOID=""/> </Branching> <WorkflowEnd EndOID=""/> </WorkflowDef> <StudyEventGroupDef </TranslatedText> </Description> </TrialPhase> <StudyTimings> <StudyTiming OID="" Name=""> ArmOID="" EpochOID="" CommentOID=""> <Description> <TranslatedText xml:lang <AbsoluteTimingConstraint OID="" Name="" typeStudyEventGroupOID=""></TranslatedText> </Description> <StudyEventGroupRef StudyEventGroupOID StudyEventOID="" MandatoryTimepointTarget="" OrderNumberTimepointPreWindow="" CollectionExceptionConditionOID TimepointPostWindow=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </StudyEventGroupRef> <StudyEventRef StudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/> <WorkflowRef WorkflowOID=""/> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> </StudyEventGroupDef> <StudyEventDef/> <RelativeTimingConstraint OID="" Name="" Type="" PredecessorOID="" SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow="" TimepointPostWindow=""/> <TransitionTimingConstraint OID="" Name="" RepeatingTransitionOID="" TypeMethodOID="" Category Type="" CommentOIDTimepointPostWindow=""> <Description> <TranslatedText xml:lang TimepointPreWindow="" typeTimepointTarget=""></TranslatedText> </Description> <Alias Context> <DurationTimingConstraint OID="" Name=""/> <ItemGroupRef ItemGroupOID DurationPostWindow="" Mandatory="" OrderNumber DurationPreWindow="" CollectionExceptionConditionOIDDurationTarget=""/> <WorkflowRef WorkflowOID StructuralElementOID=""/> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> </StudyEventDef> <ItemGroupDef OID="" Name="" Repeating="" IsReferenceData="" DatasetName="" Domain="" Type="" Purpose="" CommentOID="" MethodOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Alias Context="" Name=""/> <ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/> <ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID=""> <Origin Type="" Source=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Source> <SourceItem ItemOID="" ItemGroupOID="" leafID="" Label=""> <Resource Type="" Name="" Attribute=""> <Selection Path=""/> </Resource> </SourceItem> </Source> </Origin> </ItemRef> </StudyTiming> </StudyTimings> <StudyIndications> <StudyIndication OID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOIDref=""/> <WorkflowRef WorkflowOID CommentOID=""/> <Origin Type="" Source=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Source> <SourceItem ItemOID="" ItemGroupOID="" leafID="" Label=""> <Resource Type="" Name="" Attribute=""> <Selection Path=""/> </Resource> </SourceItem> </Source> </Origin> </ItemGroupDef> <ItemDef OID="" Name="" DataType="" Length="" CommentOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Alias Context="" Name=""/> </StudyIndication> </StudyIndications> <StudyInterventions> <StudyIntervention OID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/> <Question> <TranslatedText xml:lang="" type=""></TranslatedText> </Question> <RangeCheck Comparator="" SoftHard="" ItemOID=""> <CheckValue></CheckValue> <ErrorMessage> <TranslatedText xml:lang="" type=""></TranslatedText> </ErrorMessage> <MethodSignature> <Parameter Name="" DataType="" Definition="" OrderNumber=""/> <ReturnValue Name="" DataType="" Definition="" OrderNumber=""/> </MethodSignature> <FormalExpression Context=""> <Code></Code> <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> </FormalExpression> </RangeCheck> <CodeListRef CodeListOID=""/> </ItemDef> <CodeList </StudyIntervention> </StudyInterventions> <StudyObjectives> <StudyObjective OID="" Name="" Type=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/> </StudyObjective> </StudyObjectives> <StudyEndPoints> <StudyEndPoint OID="" Name="" DataTypeType="" CommentOIDLevel=""> <Description> <Description> <TranslatedText xml:lang="" typeType=""><> </TranslatedText> </Description> <Alias Context="" Name=""/> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID=""> <Decode> <TranslatedText xml:lang="" type=""></TranslatedText> </Decode> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Alias Context="" Name=""/> </CodeListItem> <EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID=""> <Alias Context="" Name=""/> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> </EnumeratedItem> <ExternalCodeList Dictionary </Description> <FormalExpression Context=""> <Code/> <!-- <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> </CodeList> <ConditionDef OID="" Name="" CommentOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Alias Context="" Name=""/> <MethodSignature> <Parameter Name="" DataType="" Definition="" OrderNumber=""/> <ReturnValue Name="" DataType="" Definition="" OrderNumber=""/> </MethodSignature> <FormalExpression Context=""> <Code></Code> <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> </FormalExpression> </ConditionDef> <MethodDef OID="" Name="" Type="" CommentOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Alias Context="" Name=""/> <MethodSignature> <Parameter Name="" DataType="" Definition="" OrderNumber=""/> <ReturnValue Name="" DataType="" Definition="" OrderNumber=""/> </MethodSignature> <FormalExpression Context=""> <Code></Code> --> </FormalExpression> </StudyEndPoint> </StudyEndPoints> <StudyTargetPopulation OID="" Name=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <FormalExpression Context=""> <Code/> <!-- <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> </FormalExpression> </MethodDef> <CommentDef OID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> </CommentDef> </MetaDataVersion> </Study> <AdminData StudyOID=""> <User OID="" UserType="" OrganizationOID="" LocationOID=""> <UserName></UserName> <Prefix></Prefix> <Suffix></Suffix> <FullName></FullName> <GivenName></GivenName> <FamilyName></FamilyName> <Image ImageFileName="" href="" MimeType=""/> <Address> <HouseNumber></HouseNumber> <StreetName></StreetName> <City></City> <StateProv></StateProv> <Country></Country> <PostalCode></PostalCode> <OtherText></OtherText> <GeoPosition Longitude="" Latitude="" Altitude=""/> </Address> <Telecom TelecomType="" Value=""/> </User> <Location OID="" Name="" Role="" OrganizationOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""/> <Address> <HouseNumber></HouseNumber> <StreetName></StreetName> <City></City> <StateProv></StateProv> <Country></Country> <PostalCode></PostalCode> <OtherText></OtherText> <GeoPosition Longitude="" Latitude="" Altitude=""/> </Address> <Telecom TelecomType="" Value=""/> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> </Location> <Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID=""> <Description> <TranslatedText xml:lang="" type=""></TranslatedText> </Description> <Address> <HouseNumber></HouseNumber> <StreetName></StreetName> <City></City> <StateProv></StateProv> <Country></Country> <PostalCode></PostalCode> <OtherText></OtherText> <GeoPosition Longitude="" Latitude="" Altitude=""/> </Address> <Telecom TelecomType="" Value=""/> </Organization> <SignatureDef OID="" Methodology=""> <Meaning></Meaning> <LegalReason></LegalReason> </SignatureDef> </AdminData> <ReferenceData StudyOID="" MetaDataVersionOID=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""></Value> <Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> </ItemData> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> </ItemGroupData> </ReferenceData> <ClinicalData StudyOID="" MetaDataVersionOID=""> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> --> </FormalExpression> </StudyTargetPopulation> <StudyEstimands> <StudyEstimand OID="" Name=""> <Description> <TranslatedText xml:lang="" Type=""/> </Description> <StudyTargetPopulationRef StudyTargetPopulationOID=""/> <StudyInterventionRef StudyInterventionOID=""/> <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/> <IntercurrentEvent> <Description> <TranslatedText xml:lang="" Type=""/> </Description> </IntercurrentEvent> <SummaryMeasure> <Description> <TranslatedText xml:lang="" Type=""/> </Description> </SummaryMeasure> </StudyEstimand> </StudyEstimands> <InclusionExclusionCriteria> <InclusionCriteria> <Criterion OID="" Name="" ConditionOID=""> <Description> <TranslatedText xml:lang="" Type=""/> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> </Criterion> </InclusionCriteria> <ExclusionCriteria> <Criterion OID="" Name="" ConditionOID=""> <Description> <TranslatedText xml:lang="" Type=""/> </Description> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> </Criterion> </ExclusionCriteria> </InclusionExclusionCriteria> <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> </StudyEventGroupRef> <WorkflowRef WorkflowOID=""> </WorkflowRef> <Alias Context="" Name=""> </Alias> </Protocol> <WorkflowDef OID="" Name=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <WorkflowStart StartOID=""> </WorkflowStart> <Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""> </Transition> <Branching OID="" Name="" Type=""> <TargetTransition TargetTransitionOID="" ConditionOID=""> </TargetTransition> <DefaultTransition TargetTransitionOID=""> </DefaultTransition> </Branching> <WorkflowEnd EndOID=""/> </WorkflowDef> <StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> </StudyEventGroupRef> <StudyEventRef StudyEventOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> </StudyEventRef> <WorkflowRef WorkflowOID=""> </WorkflowRef> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> </StudyEventGroupDef> <StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> </ItemGroupRef> <WorkflowRef WorkflowOID=""> </WorkflowRef> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </StudyEventDef> <ItemGroupDef OID="" Name="" Repeating="" RepeatingLimit="" IsReferenceData="" Structure="" ArchiveLocationID="" DatasetName="" Domain="" Type="" Purpose="" StandardOID="" IsNonStandard="" HasNoData="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Class Name=""> <SubClass Name="" ParentClass=""/> </Class> <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID=""> </ItemGroupRef> <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber="" Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core=""> <Origin Type="" Source=""> </Origin> <WhereClauseRef WhereClauseOID=""> </WhereClauseRef> </ItemRef> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <WorkflowRef WorkflowOID=""> </WorkflowRef> <Origin Type="" Source=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <SourceItems> <SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID="" LeafID="" Name=""> <Resource Type="" Name="" Attribute="" Label=""> <Selection Path=""/> </Resource> </SourceItem> </SourceItems> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <DocumentRef LeafID=""> </DocumentRef> </Origin> <Alias Context="" Name=""> </Alias> <Leaf ID="" xlink:href=""> <Title> </Title> </Leaf> </ItemGroupDef> <ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Question> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Question> <Prompt> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Prompt> <CRFCompletionInstructions > <TranslatedText xml:lang="" Type=""> </TranslatedText> </CRFCompletionInstructions > <ImplementationNotes > <TranslatedText xml:lang="" Type=""> </TranslatedText> </ImplementationNotes > <Definition> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Definition> <VariableSet > <TranslatedText xml:lang="" Type=""> </TranslatedText> </VariableSet > <CDISCNotes > <TranslatedText xml:lang="" Type=""> </TranslatedText> </CDISCNotes > <RangeCheck Comparator="" SoftHard="" ItemOID=""> <CheckValue/> <!-- <MethodSignature> </MethodSignature> <FormalExpression Context=""> <Code></Code> </FormalExpression> --> <ErrorMessage> <TranslatedText xml:lang="" Type=""> </TranslatedText> </ErrorMessage> </RangeCheck> <CodeListRef CodeListOID=""> </CodeListRef> <ValueListRef ValueListOID=""> </ValueListRef> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </ItemDef> <CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <Decode> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Decode> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </CodeListItem> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Alias Context="" Name=""> </Alias> </CodeList> <ConditionDef OID="" Name="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <MethodSignature> <Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter> <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue> </MethodSignature> <FormalExpression Context=""> <Code/> <!-- <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> --> </FormalExpression> <Alias Context="" Name=""> </Alias> </ConditionDef> <MethodDef OID="" Name="" Type="" CommentOID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <MethodSignature> <Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter> <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue> </MethodSignature> <FormalExpression Context=""> <Code/> <!-- <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/> --> </FormalExpression> <Alias Context="" Name=""> </Alias> <DocumentRef LeafID=""> <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/> </DocumentRef> </MethodDef> <CommentDef OID=""> <Description> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Description> <DocumentRef LeafID=""> <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/> </DocumentRef> </CommentDef> <Leaf ID="" xlink:href=""> <title> </title> </Leaf> </MetaDataVersion> </Study> <AdminData StudyOID=""> <User OID="" UserType="" OrganizationOID="" LocationOID=""> <UserName/> <Prefix/> <Suffix/> <FullName/> <GivenName/> <FamilyName/> <Image ImageFileName="" href="" MimeType=""> </Image> <Address> <StreetName/> <HouseNumber/> <City/> <StateProv/> <Country/> <PostalCode/> <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition> <OtherText/> </Address> <Telecom TelecomType="" Value=""> </Telecom> </User> <Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID=""> <Description> <TranslatedText xml:lang="" Type=""> <xhtml:div> </xhtml:div> </TranslatedText> </Description> <Address> <StreetName/> <HouseNumber/> <City/> <StateProv/> <Country/> <PostalCode/> <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition> <OtherText/> </Address> <Telecom TelecomType="" Value=""> </Telecom> </Organization> <Location OID="" Name="" Role="" OrganizationOID=""> <Description> <TranslatedText xml:lang="" Type=""> <xhtml:div> </xhtml:div> </TranslatedText> </Description> <MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""> </MetaDataVersionRef> <Address> <StreetName/> <HouseNumber/> <City/> <StateProv/> <Country/> <PostalCode/> <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition> <OtherText/> </Address> <Telecom TelecomType="" Value=""> </Telecom> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> </Query> </Location> <SignatureDef OID="" Methodology=""> <Meaning/> <LegalReason/> </SignatureDef> </AdminData> <ReferenceData StudyOID="" MetaDataVersionOID=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> </Query> </ItemData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> </Query> </ItemGroupData> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> </Query> </ItemData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> </Query> </ItemGroupData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> <xhtml:div> </xhtml:div> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> </ReferenceData> <ClinicalData StudyOID="" MetaDataVersionOID=""> <SubjectData SubjectKey="" TransactionType=""> <InvestigatorRef UserOID=""> </InvestigatorRef> <SiteRef LocationOID=""> </SiteRef> <StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> </ItemGroupData> <ItemData ItemOID="" TransactionType="" IsNull=""> </ItemData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> </Query> </ItemGroupData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> </Query> </StudyEventData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> </Query> </SubjectData> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> </Query> </ItemData> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> </AuditRecord> </Query> </ItemGroupData> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <SubjectData SubjectKey="" TransactionType=""> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <InvestigatorRef UserOID=""/> <SiteRef LocationOID=""/> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> ="" 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=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""> </> UserRef> <LocationRef LocationOID=""/> </AuditRecord> </Query> <StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType=""> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> > </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </> UserRef> <LocationRef LocationOID=""/> </AuditRecord> <Signature> LocationRef> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> > </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Coding Code ID="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq=""> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <ItemData ItemOID="" TransactionType="" IsNull=""> <Value SeqNum=""></Value> <Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> > <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> </Query> </ItemGroupData> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""> </> UserRef> <LocationRef LocationOID=""/> > </AuditRecord> </Query> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> <Signature ID=""> <UserRef UserOID=""> </> <LocationRef LocationOID=""/> </AuditRecord> <Signature> <SignatureRef SignatureOID=""/> <DateTimeStamp></DateTimeStamp> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </Signature> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> UserRef> <LocationRef LocationOID=""> </LocationRef> <SignatureRef SignatureOID=""> </SignatureRef> <DateTimeStamp/> </Signature> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> <xhtml:div> </xhtml:div> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </> <Flag> Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> </ItemData> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> </ItemGroupData> </StudyEventData> </SubjectData> <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name=""> <Value SeqNum=""></Value> <AuditRecord EditPoint="" UsedMethod=""> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> <SourceID></SourceID> <UserRef UserOID=""/> <LocationRef LocationOID=""/> </AuditRecord> </Query> </ClinicalData> <Association StudyOID="" MetaDataVersionOID=""> <KeySet StudyOID="" SubjectKey="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""/> <Annotation SeqNum="" TransactionType=""> <Comment></Comment> <Value SeqNum=""/> <AuditRecord EditPoint="" UsedMethod=""> <UserRef UserOID=""> </UserRef> <LocationRef LocationOID=""> </LocationRef> <DateTimeStamp/> <ReasonForChange/> <SourceID/> </AuditRecord> </Query> </ClinicalData> <Association StudyOID="" MetaDataVersionOID=""> <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet> <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet> <Annotation SeqNum="" TransactionType="" ID=""> <Comment SponsorOrSite=""> <TranslatedText xml:lang="" Type=""> <xhtml:div> </xhtml:div> </TranslatedText> </Comment> <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </> <Flag> Coding> <Flag> <FlagValue CodeListOID=""/> <FlagType CodeListOID=""/> </Flag> </Annotation> </Association> </ODM> |