The InclusionExclusionCriteria element can contain two lists of Criterion elements, represented by the two elements InclusionCriteria and ExclusionCriteria. Together, these criteria determine the eligibility of a subject for the study. The actual condition to be evaluated is contained in an ODM ConditionDef, which is referenced by each Criterion‟s ConditionOID attribute.
Element Name | InclusionExclusionCriteria |
---|---|
Parent Element(s) | Protocol |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria |
Element Textual Value | None |
Usage | Optional |
Attributes | None |
Child Elements | (InclusionCriteria?, ExclusionCriteria? |