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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

Code Block
languagexml
themeConfluence
titleTemplatelinenumberstrueODM v2.0 Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM 
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	xmlns    xmlns:xlink="http://www.cdiscw3.org/ns/odm/v2.0" 
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	    AsOfDateTime="2023-08-23T00:00:00"
	    ODMVersion="2.0-R1" 
	    Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi" 	 
	" 
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				<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/>
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                            DurationPreWindow="" CollectionExceptionConditionOIDDurationTarget=""/>
				<WorkflowRef WorkflowOID StructuralElementOID=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
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				<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
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                <StudyIndications>
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                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOIDref=""/>
				<WorkflowRef WorkflowOID CommentOID=""/>
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						<TranslatedText xml:lang="" type=""></TranslatedText>
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					<Source>
						<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
							<Resource Type="" Name="" Attribute="">
								<Selection Path=""/>
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			<ItemDef OID="" Name="" DataType="" Length="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				                    </StudyIndication>
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                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
				<Question> 
					<TranslatedText xml:lang="" type=""></TranslatedText>
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				<RangeCheck Comparator="" SoftHard="" ItemOID="">
					<CheckValue></CheckValue>
					<ErrorMessage>
						<TranslatedText xml:lang="" type=""></TranslatedText>
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					<MethodSignature>
						<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
						<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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					<FormalExpression Context="">
						<Code></Code>
						<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
					</FormalExpression>
				</RangeCheck>
				<CodeListRef CodeListOID=""/>
			</ItemDef>
			<CodeList                    </StudyIntervention>
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                <StudyObjectives>
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                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
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				<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>
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					<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
					<Alias Context="" Name=""/>
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				<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=""/>
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			<ConditionDef OID="" Name="" CommentOID="">
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				</Description>
				<Alias Context="" Name=""/>
				<MethodSignature>
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					<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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				<FormalExpression Context="">
					<Code></Code>
					<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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					<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>
					                        -->
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                <StudyTargetPopulation OID="" Name="">
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                        <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>
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			<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=""/>	
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			<Telecom TelecomType="" Value=""/>
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		<Location OID="" Name="" Role="" OrganizationOID="">
			<Description>
				<TranslatedText xml:lang="" type=""></TranslatedText>
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			<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=""/>
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		<Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
			<Description>
				<TranslatedText xml:lang="" type=""></TranslatedText>
			</Description>	
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				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
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			<Telecom TelecomType="" Value=""/>
		</Organization>
		<SignatureDef OID="" Methodology="">
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			<LegalReason></LegalReason>	
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			<AuditRecord EditPoint="" UsedMethod="">
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				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
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				<DateTimeStamp></DateTimeStamp>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
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			<Annotation SeqNum="" TransactionType="">
				<Comment></Comment>
				<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
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			<ItemData ItemOID="" TransactionType="" IsNull="">
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				<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
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					<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>
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                        <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>
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                <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=""/>
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            <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>
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					        <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>