<ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" Repeating="No">
...<ItemRef ItemOID="ID.GENDER" Mandatory="Yes">
<ItemRef ItemOID <Origin Type="IDef.GENDERCollected" MandatorySource="YesSponsor"/>></Origin>
</ItemRef>
<ItemRef ItemOID="IDefID.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
</ItemGroupDef>
<Origin Type="Collected" Source="Sponsor">
<Source>
<SourceItem>
<Resource Type="ID.GENDER" Name="Gender"></Resource>
</SourceItem>
</Source>
</Origin>
</ItemGroupDef>
<ConditionDef <ConditionDef OID="CECID.ISMALE" Name="Subject's gender is Male">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Do not collect data for Male subjects</TranslatedText>
</Description>
<MethodSignature>
<Parameter Name="Gender" DataType="text"></Parameter>
<ReturnValue Name="IsMale" DataType="boolean"></ReturnValue>
</MethodSignature>
<FormalExpression Context="PL/SQL">
<Code>INCLUSION.IDef.GENDER <Code>IsMale = (Gender := 'Male')</Code>
< </FormalExpression>
</ConditionDef> |