Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM
xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xmlns:xlink="http://www.w3.org/1999/xlink"
xmlns="http://www.cdisc.org/ns/odm/v2.0"
xsi:schemaLocation=""
FileType=""
Granularity=""
Context=""
FileOID=""
CreationDateTime="2021-05-13"
PriorFileOID=""
AsOfDateTime=""
ODMVersion="2.0-R1"
Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi"
SourceSystem=""
SourceSystemVersion=""
Description="CDISC ODM v2.0 Template"
ID="">
<Study OID="" StudyName="" ProtocolName="">
<Description>
<TranslatedText></TranslatedText>
</Description>
<MetaDataVersion OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""/>
<Protocol>
<Description>
<TranslatedText xml:lang="" type=""></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="" PlannedDuration="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""/>
</StudyStructure>
<StudySummary>
<!-- Draft Note 5/13/2021: Created https://jira.cdisc.org/browse/ODM2DEV-78 due to a reference to StudyParameters under https://wiki.cdisc.org/display/ODM2/ParameterValue which is not represented in the ODM v2.0 specification-->
<StudyParameter OID="" Term="" ShortName="">
<ParameterValue Value="">
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</ParameterValue>
</StudyParameter>
</StudySummary>
<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</StudyEventGroupRef>
<StudyTiming OID="" Name="">
<TransitionTimingConstraint OID="" Name="" TransitionOID="" TimepointTarget="" MethodOID="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</TransitionTimingConstraint>
<AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID="" StudyEventOID="" TimepointTarget="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</AbsoluteTimingConstraint>
<DurationTimingConstraint OID="" Name="" StruturalElementOID="" DurationTarget="" DurationPreWindow=""/>
<RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" RelativeTimepointTarget="" Type="" TimepointPreWindow="" TimepointPostWindow="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</RelativeTimingConstraint>
</StudyTiming>
</Protocol>
<WorkflowDef OID="" Name="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<WorkflowStart StartOID=""/>
<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/>
<Branching OID="" Name="" Type="">
<TargetTransition TargetTransitionOID="" ConditionOID=""/>
<DefaultTransition TargetTransitionOID=""/>
</Branching>
<WorkflowEnd EndOID=""/>
</WorkflowDef>
<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<StudyEventRef StudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<WorkflowRef WorkflowOID=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</StudyEventGroupDef>
<StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
<WorkflowRef WorkflowOID=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" 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="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
<Origin Type="" SourceType="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Source>
<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
<Resource Type="" Name="" Attribute="">
<Selection Path=""/>
</Resource>
</SourceItem>
</Source>
</Origin>
</ItemRef>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<WorkflowRef WorkflowOID=""/>
<Origin Type="" SourceType="">
<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="" FractionDigits="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<WorkflowRef WorkflowOID=""/>
<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="">
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
<!-- Repeating -->
</ReturnValue>
</ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</RangeCheck>
<CodeListRef CodeListOID=""/>
</ItemDef>
<CodeList OID="" Name="" DataType="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<CodeListItem CodedValue="" Rank="" OrderNumber="" CommentOID="">
<Decode>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Decode>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
<Alias Context="" Name=""/>
</CodeListItem>
<EnumeratedItem CodedValue="" Rank="" OrderNumber="" CommentOID="">
<Alias Context="" Name=""/>
<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
</EnumeratedItem>
<!-- Draft Note: Create https://jira.cdisc.org/browse/ODM2DEV-80 to recommend adding a CommentOID attribute to ExternalCodeList -->
<ExternalCodeList Dictionary="" Version="" ref="" href=""/>
</CodeList>
<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="">
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
<!-- Repeating -->
</ReturnValue>
</ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</MethodDef>
<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="">
<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
<!-- Repeating -->
</ReturnValue>
</ReturnValue>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
</FormalExpression>
</ConditionDef>
<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="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
</Location>
<Organization OID="" Name="" 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>
<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>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</ItemData>
<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>
</ItemGroupData>
<AuditRecord EditPoint="" UsedImputationMethod="" ID="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID="">
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue>
<TranslatedText xml:lang="" type=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" type=""></TranslatedText>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</ReferenceData>
<ClinicalData StudyOID="" MetaDataVersionOID="">
<SubjectData SubjectKey="" TransactionType="">
<AuditRecord EditPoint="" UsedImputationMethod="" ID="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID="">
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue>
<TranslatedText xml:lang="" type=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" type=""></TranslatedText>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<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>
<InvestigatorRef UserOID=""/>
<SiteRef LocationOID=""/>
<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
<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>
<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>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</ItemData>
<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>
</ItemGroupData>
<AuditRecord EditPoint="" UsedImputationMethod="" ID="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature ID="">
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue>
<TranslatedText xml:lang="" type=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" type=""></TranslatedText>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
<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>
</StudyEventData>
</SubjectData>
<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>
</ClinicalData>
<Association StudyOID="" MetaDataVersionOID="">
<KeySet StudyOID="" SubjectKey="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""/>
<Annotation SeqNum="" TransactionType="" ID="">
<AnnotationValue>
<TranslatedText xml:lang="" type=""></TranslatedText>
</AnnotationValue>
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" type=""></TranslatedText>
</Comment>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</Association>
<ds:Signature xmlns="http://www.w3.org/2000/09/xmldsig#" Id="1">
<SignedInfo></SignedInfo>
<SignatureValue></SignatureValue>
<KeyInfo></KeyInfo>
<Object></Object>
</ds:Signature>
</ODM>