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Element Name | WorkflowRef |
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Parent Elements | Protocol, StudyStructure, Arm, StudyEventDef, StudyEventGroupDef |
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Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/WorkflowRef /ODM/Study/MetaDataVersion/Protocol/StudyStructure/WorkflowRef /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm/WorkflowRef /ODM/Study/MetaDataVersion/Study/MetaDataVersion/StudyEventDef/WorkflowRef /ODM/Study/MetaDataVersion/Study/MetaDataVersion/StudyEventGroupDef/WorkflowRef |
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Element Textual Value | None |
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Attributes | WorkflowOID |
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Child Elements | None |
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Usage/Business Rules | - a WorkflowRef is provided for a StudyStructure and for one or more StudyStructure/Arm elements, the WorkflowDef refenced by the Arm element overides the WorkflowDef referenced by the StudyStructure.
- If a WorkflowRef is provided for a StudyStructure and one or more Arm child elements do not include a WorkflowRef, the WorkflowDef refenced at the StudyStructure level applies.
- Other Information:
- In a case where all study arms have the same workflow (e.g., a blinded trial of study drug vs. placebo), WorkFlowRef will be provided in the StudyStructure element. In the case where activities for different arms are different (e.g., drug arm with comparator surgery), WorkflowRef will be provided on the Arm element.
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