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Element Name | Arm |
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Parent Elements | StudyStructure |
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Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm |
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Element Textual Value | None |
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Attributes | OID, Name |
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Child Elements | (Description?, WorkflowRef?) |
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Usage/Business Rules | - Other Information:
- When different arms have different workflows, each of them will reference a different WorkflowDef element under MetaDataVersion. In the case where all arms have the same workflow (e.g., in a double-blind study), a single WorkflowDef element under MetaDataVersion can describe the common workflow. In such a case every arm will reference the same workflow.
- A CDISC SDTM Trial Design element (the basic building block in the SDTM trial design) will be represented by a StudyEventGroup referenced from the arm workflow.
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