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(Description, MethodSignature, FormalExpression*, Alias*)

• The Description element must be provided and should include a prose description.
• The MethodSignature element must also be provided and identifies the input parameter and return values for the ConditionDef.

• Business Rule(s):
  • The MethodSignature ReturnValue for ConditionDef must always equal boolean.
  • If a FormalExpression is provided, it must contain a machine-readable expression that will evaluate to True or False.
• Other Information:
  • The Description and MethodSignature are the normative content of the ConditionDef. 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).
  • Multiple FormalExpressions can be provided if each has a different Context attribute, allowing the same expression to be represented in forms appropriate to multiple systems.
  • 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.