<ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" Repeating="No">
<ItemRef ItemOID="ID.GENDER" Mandatory="Yes">
<Origin Type="Collected" Source="Sponsor"></Origin>
>
</ItemRef>
<Source>
<ItemRef ItemOID="ID.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
<SourceItem>
<Origin <Resource Type="Collected"ODM" Name="ItemDef" SourceLabel="SponsorGender">
<Source>
<Selection Path="../../ItemDef[@OID='ID.GENDER']/@Value"/>
<SourceItem>
</Resource>
<Resource Type="ODM" Name="ItemDef" Label="Gender">
</SourceItem>
<Selection Path="../../ItemDef[@OID='ID.GENDER']/@Value"></Selection>
</Source>
</Resource>Origin>
</ItemRef>
</SourceItem>
<ItemRef ItemOID="ID.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE">
<Origin </Source>Type="Collected" Source="Sponsor"/>
</Origin>ItemRef>
</ItemGroupDef>
<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>IsMale = (Gender := 'Male')</Code>>
</FormalExpression>
</ConditionDef> |