<?xml version="1.0" encoding="UTF-8"?>
<ODM
xmlns:xsixmlns="http://www.cdisc.org/ns/odm/v2.0" xmlns:xhtml="http://www.w3.org/20011999/XMLSchema-instancexhtml"
xmlns:xlink="http://www.w3.org/1999/xlink"
xmlns xmlns:nci="http://wwwncicb.nci.cdiscnih.orggov/nsxml/odm/EVS/v2.0"
xsi:schemaLocation=""
FileType=""
Granularity=""
Context=""
FileOID=""
CreationDateTime="2022-07-11"
PriorFileOID=""
AsOfDateTime=""
CDISC"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xsi:schemaLocation="http://www.cdisc.org/ns/odm/v2.0 file:/C:/_github/cdisc-org/DataExchange-ODM/schema/ODM.xsd"
FileType="Snapshot" Granularity="All" Context="Exchange" FileOID="ODMv2.0"
CreationDateTime="2022-10-11T00:00:00" PriorFileOID="ODMv2.0" AsOfDateTime="2022-10-11T00:00:00"
ODMVersion="2.0-R1"
Originator="CDISC Data Exchange Standards ODM v2.0 Team" -SourceSystem=""
Template Authored by Mike Hamidi"
SourceSystem=""
SourceSystemVersion="">
<Description>
SourceSystemVersion="">
<Description>
<TranslatedText xml:lang="" type="">CDISC>
<xhtml:div>CDISC ODM v2.0 Abstract Template</xhtml:div>
</TranslatedText>
</Description>
<Study OID="ODMv2.0" StudyName="ODMv2.0" ProtocolName="ODMv2.0">
<Description>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<MetaDataVersion OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""/>
<Protocol>
<Description>
>
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<MetaDataVersion OID="" Name="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Alias Context="" Name=""/>
<StudyStructure>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<Arm>
<xhtml:div> </xhtml:div>
</TranslatedText>
</Description>
<Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
<Standards>
<Standard OID="" Name="">
<Description>
<TranslatedText xml:lang Type="" typePublishingSet=""></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>
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="" 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>
</Description>
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
Mandatory="" CollectionExceptionConditionOID="">
<Origin Type="" Source=""> </Origin>
<WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
</ItemRef>
</ValueListDef>
<WhereClauseDef OID="" CommentOID="">
<RangeCheck Comparator="" SoftHard="" ItemOID="">
<CheckValue/>
<!--
<MethodSignature>
</MethodSignature>
<FormalExpression Context="">
<Code></Code>
</FormalExpression>
-->
<ErrorMessage>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</ErrorMessage>
</RangeCheck>
</WhereClauseDef>
<Protocol>
<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>
<StudySummary>
<StudyParameter OID="" Term="" ShortName="">
<ParameterValue Value="">
<Coding Code="" System="" SystemName="" SystemVersion="" Label=""
href="" CommentOID=""/>
</ParameterValue>
</StudyParameter>
</StudySummary>
<StudyStructure>
<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 </Description>
<Arm OID="" Name="" ConditionOID="">
<Description>
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</Criterion>
</InclusionCriteria>
<ExclusionCriteria>
<Criterion>
</Description>
<WorkflowRef WorkflowOID=""/>
</Arm>
<Epoch OID="" Name="" ConditionOIDSequenceNumber="">
<Description>
<TranslatedText xml: <Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</Criterion>
</ExclusionCriteria>
</InclusionExclusionCriteria>
<TrialPhase Value="">
<Description>
>
</Description>
</Epoch>
<WorkflowRef WorkflowOID=""> </WorkflowRef>
</StudyStructure>
<TrialPhase Value="PHASE 0 TRIAL">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
</TrialPhase>
</Protocol>
<WorkflowDef> </TranslatedText>
</Description>
</TrialPhase>
<StudyTimings>
<StudyTiming OID="" Name="">
<Description>
<TranslatedText xml:lang <AbsoluteTimingConstraint OID="" Name="" typeStudyEventGroupOID=""></TranslatedText>
</Description>
<WorkflowStart StartOID=""/>
<Transition OID
StudyEventOID="" TimepointTarget="" NameTimepointPreWindow="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID
TimepointPostWindow=""/>
<Branching <RelativeTimingConstraint OID="" Name="" Type="">
<TargetTransition TargetTransitionOID PredecessorOID=""
SuccessorOID="" ConditionOIDTimepointRelativeTarget=""/>
<DefaultTransition TargetTransitionOID TimepointPreWindow=""/>
</Branching>
<WorkflowEnd EndOID
TimepointPostWindow=""/>
</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>
<SourceItems>
<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
<Resource Type="" Name="" Attribute="">
<Selection Path=""/>
</Resource>
</SourceItem>
</SourceItems>
</Origin>
</ItemRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID=""/>
<WorkflowRef WorkflowOID=""/>
<Origin Type="" Source="">
<Description>
<TranslatedText xml:lang="" type=""></TranslatedText>
</Description>
<SourceItems>
<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
<Resource Type="" Name="" Attribute="">
<Selection Path=""/>
</Resource>
</SourceItem>
</SourceItems>
</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>
<TransitionTimingConstraint OID="" Name="" TransitionOID="" MethodOID=""
Type="" TimepointPostWindow="" TimepointPreWindow="" TimepointTarget=""/>
<DurationTimingConstraint OID="" Name="" DurationPostWindow=""
DurationPreWindow="" DurationTarget="" StructuralElementOID=""/>
</StudyTiming>
</StudyTimings>
<StudyIndications>
<StudyIndication OID="">
<Description>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
CommentOID=""/>
</StudyIndication>
</StudyIndications>
<StudyInterventions>
<StudyIntervention OID="">
<Description>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
CommentOID=""/>
</StudyIntervention>
</StudyInterventions>
<StudyObjectives>
<StudyObjective OID="" Name="" Type="">
<Description>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</Description>
<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
</StudyObjective>
</StudyObjectives>
<StudyEndPoints>
<StudyEndPoint OID="" Name="" Type="">
<Description>
<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 -->
</FormalExpression>
</StudyEndPoint>
</StudyEndPoints>
<StudyTargetPopulation OID="" Name="" Type="" CommentOID="">
<Description>
>
<Description>
<TranslatedText xml:lang="" type=""><> </TranslatedText>
</Description>
<Alias Context </Description>
<Coding Code="" System="" NameSystemName=""/>
<MethodSignature>
<Parameter Name SystemVersion="" DataTypeLabel="" Definitionhref="" OrderNumber=""/>
<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
</MethodSignature>
CommentOID=""> </Coding>
<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>
<Code/>
<!--
<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
-->
</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=""></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>
</IntercurrentEvent>
<SummaryMeasure>
<Description>
<TranslatedText xml:lang="" type=""/>
</Description>
</SummaryMeasure>
</StudyEstimand>
</StudyEstimands>
<InclusionExclusionCriteria>
<InclusionCriteria>
<Criterion OID="" Name="" ConditionOID=""> </Criterion>
</InclusionCriteria>
<ExclusionCriteria>
<Criterion OID="" Name="" ConditionOID=""> </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=""
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=""
CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</StudyEventDef>
<ItemGroupDef OID="" Name="" Repeating="" RepeatingLimit="" IsReferenceData=""
Structure="" ArchiveLocationID="" DatasetName="" Domain="" Type="Concept" Purpose=""
StandardOID="" IsNonStandard="" HasNoData="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type=""> </TranslatedText>
</Description>
<Class Name="">
<SubClass Name="" ParentClass="ADAM OTHER"/>
</Class>
<ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
CollectionExceptionConditionOID=""> </ItemGroupRef>
<ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
Mandatory="" CollectionExceptionConditionOID="">
<Origin Type="" Source=""> </Origin>
<WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
</ItemRef>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
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=""
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>
<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=""
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=""
CommentOID=""> </Coding>
<Alias Context="" Name=""> </Alias>
</CodeListItem>
<!--
<EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue="" CommentOID="">
<Description>
<TranslatedText xml:lang="" type="">
</TranslatedText>
</Description>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" CommentOID="">
</Coding>
<Alias Context="" Name="">
</Alias>
</EnumeratedItem>
-->
<ExternalCodeList Dictionary="CDISC CT" Version="" href="" ref=""> </ExternalCodeList>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
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=""
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=""> </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=""
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="" 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=""
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=""
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=""
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=""></Value>
<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
<Value SeqNum=""></Value>
>
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID>
<UserRef UserOID=""/>
> </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>
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=""> </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=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
</Query>
<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionTypeUserRef>
<LocationRef LocationOID="">
<AuditRecord EditPoint="" UsedMethod="">
<DateTimeStamp></DateTimeStamp>
<ReasonForChange></ReasonForChange>
<SourceID></SourceID>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</AuditRecord>
<Signature>
<SignatureRef SignatureOID=""/>
<DateTimeStamp></DateTimeStamp>
<UserRef UserOID=""/>
<LocationRef LocationOID=""/>
</Signature>
</LocationRef>
<DateTimeStamp/>
<ReasonForChange/>
<SourceID/>
</AuditRecord>
<Signature ID="">
<UserRef UserOID=""> </UserRef>
<LocationRef LocationOID=""> </LocationRef>
<SignatureRef SignatureOID=""> </SignatureRef>
<DateTimeStamp/>
</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>
ID="">
<Comment SponsorOrSite="">
<TranslatedText xml:lang="" type=""> </TranslatedText>
</Comment>
<Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
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="" 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="" CommentOID=""> </>
<Flag>
Coding>
<Flag>
<FlagValue CodeListOID=""/>
<FlagType CodeListOID=""/>
</Flag>
</Annotation>
</Association>
</ODM>
|