<?xml version="1.0" encoding="UTF-8"?> <ODM> <Study> <MetaDataVersion> <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" Repeating="Yes"/> <ItemGroupRef ItemGroupOID="ODM.IG.RACEOTH" Mandatory="No" Repeating="Yes" RepeatingLimit="2"/> </ItemGroupDef> <ItemGroupDef OID="ODM.IG.RACE" Name="Race" Repeating="Yes"> <ItemRef ItemOID="IT.DM.RACE" Mandatory="Yes"/> </ItemGroupDef> <ItemGroupDef OID="ODM.IG.RACEOTH" Name="Race Other(s)" Repeating="Yes"> <ItemRef ItemOID="IT.DM.RACEOTH" Mandatory="No" Other="Yes"/> </ItemGroupDef> <ItemDef OID="IT.DM.RACE" Name="RACE" DataType="text" Length="41" Repeating="Yes"> <Description> <TranslatedText xml:lang="en">Race</TranslatedText> </Description> <Question> <TranslatedText xml:lang="en">Race (Select all that apply)</TranslatedText> </Question> <CodeListRef CodeListOID="CL.RACE"/> </ItemDef> <ItemDef OID="IT.DM.RACEOTH" Name="RACEOTH" DataType="text" Length="41" Repeating="Yes" RepeatLimit="2"> <Description> <TranslatedText xml:lang="en">Race Other</TranslatedText> </Description> <Question> <TranslatedText xml:lang="en">Other Race (Include maximum two other values not listed under RACE)</TranslatedText> </Question> </ItemDef> </MetaDataVersion> </Study> <!-- Clinical Data --> <ClinicalData> <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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