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| Element Name | StudyStructure |
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| Parent Elements | Protocol |
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| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyStructure |
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| Element Textual Value | None |
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| Attributes | None |
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| Child Elements | (Description?, Arm*, Epoch*, WorkflowRef*) |
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| Usage/Business Rules | - Requirement
- Conditional: Must be provided when the /ODM/@FileType is Transactional and /ODM/@Granularity in (All, AllClinicalData, SingleSite, SingleSubject).
- Cardinality: Exactly one
- Business Rule(s): Beyond what is required for schema validation, these represent conformance rules that must be satisfied for a ODM document to be considered compliant with this specification.
- Other Information:
Each arm is described as a workflow containing references to StudyEventGroups that represent the building blocks. The overall structure of the study for all arms can be described in a workflow that is directly referenced by StudyStructure.
StudyEventGroups can be "nested" (by reference), so a CDISC SDTM Trial Design element (the basic building block in the trial design) will be represented by a referenced StudyEventGroup from the arm workflow.
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