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 |
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Parent Element(s) | Protocol |
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Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria |
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Element Textual Value | None |
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Usage | Optional |
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Attributes | None |
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Child Elements | (InclusionCriteria?, ExclusionCriteria?
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Example:
Include Page |
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| InclusionExclusionCriteria Example |
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| InclusionExclusionCriteria Example |
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