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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:xsi="http://www.w3.org/2001/XMLSchema-instance" FileType="" Granularity="" Context="" FileOID="" CreationDateTime="20222023-1008-12T0023T00:00:00" PriorFileOID="" AsOfDateTime="20222023-1008-12T0023T00:00:00" 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 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 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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<TranslatedText Contextxml: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> 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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> 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<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> 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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 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<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> |