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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?)
Usage/Business Rules
  • Business Rule(s): 
    • Must be provided when the /ODM/@FileType is Transactional and /ODM/@Granularity in (All, AllClinicalData, SingleSite, SingleSubject).
  • Other Information:

    • Each arm is described as a workflow containing references to 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.


The StudyStructure element describes the general structure of a clinical study with Arms, Epochs and Workflows. 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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