This example illustrates a data-collection instrument designed to collect data for an item IsPregnant for an item group InclusionCriteria, omitted for male subjects. The referenced ConditionDef would be defined as illustrated below. When the FormalExpression evaluates to True, the Item with OID IG.ISPREG need not be collected.
ItemRef with ConditionDef Example
<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>