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? |