...
| Code Block | ||||||
|---|---|---|---|---|---|---|
| ||||||
<ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" Repeating="No" Type="Section">
<ItemRef ItemOID="ID.GENDER" Mandatory="Yes">
<Origin Type="Collected" Source="Sponsor"></Origin>
</ItemRef>
<ItemRef ItemOID="ID.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
<Origin Type="Collected" Source="Sponsor">
<SourceItems>
<SourceItem>
<Resource Type="ODM" Name="ItemDef" Label="Gender">
<Selection Path="../../ItemDef[@OID='ID.GENDER']/@Value"></Selection>
</Resource>
</SourceItem>
</SourceItems>
</Origin>
</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"/>
<ReturnValue Name="IsMale" DataType="boolean"/>
</MethodSignature>
<FormalExpression Context="PL/SQL">
<Code>IsMale = (Gender := 'Male')</Code>
</FormalExpression>
</ConditionDef> |
...