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 |
| Attribute | Schema DataType or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier. | |
| Name | name | Required | Criterion name. | |
| ConditionOID | oidref | Optional | Reference to a ConditionDef element. |
|