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A ConditionDef defines a boolean condition. The Description element must be provided and should include a prose description. This is The MethodSignature element must also be provided and identifies the input parameter and return values for the ConditionDef. The MethodSignature ReturnValue for ConditionDef must always equal boolean. The Description and MethodSignature are the normative content of the ConditionDef. The The ConditionDef is referenced by the CollectionExceptionConditionOID attribute within a study metadata component which may be omitted under circumstances defined by the condition, i.e., when the FormalExpression evaluates to True.
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If an application cannot interpret any of the FormalExpressions or does not normally support conditional data collection, data for the referencing study metadata component should be collected as though no Condition is specified.
In cases where a MethodSignature element exists without an associated FormalExpression, the MethodSignature supports improved traceability. It also serves the case where one role defines the MethodDef or ConditionDef, but another role provides the executable FormalExpression.
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