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changes.mady.by.user Marcelina Hungria

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changes.mady.by.user Lex Jansen

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Element NameStudyStructure
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudyStructure

Element Textual ValueNone
Attributes

None

Child Elements(Description?, Arm*, Epoch*, WorkflowRef
*Conditional:
?)
Usage/Business Rules
Requirement
  • Business Rule(s): 
  • 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.
      • Must be provided when the /ODM/@FileType is Transactional and /ODM/@Granularity in (All, AllClinicalData, SingleSite, SingleSubject).
  • Cardinality: Exactly one
    • Other Information:

      • Each arm is described as a workflow containing references to

    StudyEventGroups that

      • StudyEventGroupDef elements 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.