The InclusionExclusionCriteria element can contain 2 lists of Criterion elements, represented by the 2 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?
|
|---|
| Include Page |
|---|
| InclusionExclusionCriteria Example |
|---|
| InclusionExclusionCriteria Example |
|---|
|