<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0" FileOID="MyStudy_1" FileType="Snapshot" CreationDateTime="2019-03-11T17:33:17">
<Study OID="MyStudy" StudyName="My Study">
<MetaDataVersion OID="MDV.MyStudy.001" Name="Study MyStudy 001, Data Definitions V-1">
<ItemGroupDef OID="ODM.IG.DM" Name="Demographics" Repeating="No">
<ItemRef ItemOID="IT.DM.BRTHYR" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.BRTHMO" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.BRTHDY" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.SEX" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.ETHNIC" Mandatory="Yes"/>
<ItemGroupRef ItemGroupOID="ODM.IG.RACE" Mandatory="Yes" />
<ItemGroupRef ItemGroupOID="ODM.IG.RACEOTH" Mandatory="No"/>
</ItemGroupDef>
<ItemGroupDef OID="ODM.IG.RACE" Name="Race" Repeating="Static">
<ItemRef ItemOID="IT.DM.RACE" Mandatory="Yes" />
</ItemGroupDef>
<ItemGroupDef OID="ODM.IG.RACEOTH" Name="Race Other(s)" Repeating="Simple" RepeatingLimit="2">
<ItemRef ItemOID="IT.DM.RACEOTH" Mandatory="No" Repeat="Yes"/>
</ItemGroupDef>
<ItemDef OID="IT.DM.RACE" Name="RACE" DataType="text" Length="41">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Race</TranslatedText>
</Description>
<Question>
<TranslatedText xml:lang="en" type="text/plain">Race (Select all that apply)</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.RACE"/>
</ItemDef>
<ItemDef OID="IT.DM.RACEOTH" Name="RACEOTH" DataType="text" Length="41">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Race Other</TranslatedText>
</Description>
<Question>
<TranslatedText xml:lang="en" type="text/plain">Other Race (Include maximum two other values not
listed under RACE)</TranslatedText>
</Question>
</ItemDef>
</MetaDataVersion>
</Study>
<!-- Clinical Data -->
<ClinicalData StudyOID="MyStudy" MetaDataVersionOID="MDV.MyStudy.001">
<!-- Usually, the ItemGroupData is embedded within SubjectData-StudyEventData-(ItemGroupData).
This is however omitted here for clarity -->
<ItemGroupData ItemGroupOID="IG.DM" ItemGroupDataSeq="2">
<ItemData ItemOID="IT.STUDYID">
<Value>CDISC01</Value>
</ItemData>
<ItemData ItemOID="IT.DM.DOMAIN">
<Value>DM</Value>
</ItemData>
<ItemData ItemOID="IT.USUBJID">
<Value>CDISC01.100014</Value>
</ItemData>
<ItemData ItemOID="IT.DM.SUBJID">
<Value>100014</Value>
</ItemData>
<ItemData ItemOID="IT.DM.SITEID">
<Value>100</Value>
</ItemData>
<ItemData ItemOID="IT.DM.BRTHDTC">
<Value>1936-11-01</Value>
</ItemData>
<ItemData ItemOID="IT.DM.AGE">
<Value>66</Value>
</ItemData>
<ItemData ItemOID="IT.DM.AGEU">
<Value>YEARS</Value>
</ItemData>
<ItemData ItemOID="IT.DM.SEX">
<Value>F</Value>
</ItemData>
<ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="1">
<ItemData ItemOID="IT.DM.RACE">
<Value>NATIVE HAWAIIAN</Value>
</ItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="2">
<ItemData ItemOID="IT.DM.RACE">
<Value>ASIAN</Value>
</ItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="3">
<ItemData ItemOID="IT.DM.RACE">
<Value>WHITE</Value>
</ItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="1">
<ItemData ItemOID="IT.DM.RACEOTH">
<Value>Other free text Race value"</Value>
</ItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="2">
<ItemData ItemOID="IT.DM.RACEOTH">
<Value>Another free text Race value</Value>
</ItemData>
</ItemGroupData>
</ItemGroupData>
</ClinicalData>
</ODM>
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