The Criterion represents either an inclusion or an exclusion criterion, depending on the parent element (i.e., InclusionCriteria, ExclusionCriteria).
The condition itself is represented by a reference to a ConditionDef element, for which the evalutation must lead to "true" or "false".
| Element Name | Criterion |
|---|---|
| Parent Elements | InclusionCriteria, ExclusionCriteria |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion |
| Element Textual Value | None |
| Attributes | OID, Name, ConditionOID |
| Child Elements | (Description?, Coding*) |
| Usage/Business Rules |
Overview
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