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The Criterion represents either an inclusion or an exclusion criterion dependent on the parent element 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 NameCriterion
Parent ElementsInclusionCriteria, ExclusionCriteria
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion
/ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion

Element Textual ValueNone
Usage/Business Rules
  • Required
  • Cardinality: 1 or more
AttributesOID, Name, ConditionOID
Child ElementsDescription?


AttributeSchema DataType or EnumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier.
NamenameRequiredCriterion name.
ConditionOIDoidrefOptionalReference to a ConditionDef element.Must match a ConditionDef/@OID child element.


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