ODM Template

<?xml version="1.0" encoding="UTF-8"?>
<ODM 
	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="2022-07-11"
	PriorFileOID=""
	AsOfDateTime=""
	ODMVersion="2.0-R1"
	Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi" 	 
	SourceSystem="" 
	SourceSystemVersion="">
	<Description>
		<TranslatedText xml:lang="" type="">CDISC ODM v2.0 Abstract Template</TranslatedText>
	</Description>
  	<Study OID="" StudyName="" ProtocolName="">
		<Description>
			<TranslatedText xml:lang="" type=""></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="">
						<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>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
				</StudyEventGroupRef>		
				<StudyTimings>
					<StudyTiming OID="" Name="">
						<TransitionTimingConstraint OID="" Name="" TransitionOID="" TimepointTarget="" MethodOID="" Type="" 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="" DurationPostWindow="">
							<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>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
						<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
						<StudyInterventionRef StudyInterventionOID=""/>
						<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>	
						<InterCurrentEvent>	
							<Description>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>		
						</InterCurrentEvent>		
						<SummaryMeasure>	
							<Description>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>		
						</SummaryMeasure>								
					</StudyEndPoint> 
				</StudyEndPoints>
				<StudyEstimands>
					<StudyEstimand OID="" Name="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
						<FormalExpression Context="">
							<Code></Code>
							<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
						</FormalExpression>
					</StudyEstimand> 
				</StudyEstimands>
				<StudyObjectives>
					<StudyObjective OID="" Name="" Type="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
						<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>	
					</StudyObjective> 
				</StudyObjectives>
				<StudyTargetPopulation OID="" Name="">
					<Description>
						<TranslatedText xml:lang="" type=""></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>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>						
						</Criterion>
					</InclusionCriteria>
					<ExclusionCriteria>
						<Criterion OID="" Name="" ConditionOID="">
							<Description>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>						
						</Criterion>
					</ExclusionCriteria>
				</InclusionExclusionCriteria>
				<TrialPhase Value="">
					<Description>
						<TranslatedText xml:lang="" type=""></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="" 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="">
					<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 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="" 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>
				<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<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=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" 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 OID="" Name="" DataType="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></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="" 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>
					<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>
			<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>
				<AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</AuditRecord>
			</Query>
			<StudyEventData StudyEventOID="" StudyEventRepeatKey="" 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>		
				<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>
					<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>
							<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>
			</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>
			<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
			<Flag> 
				<FlagValue CodeListOID=""/>
				<FlagType CodeListOID=""/>
			</Flag>
		</Annotation>
	</Association>
</ODM>