Element Name | StudyStructure |
---|---|
Parent Elements | Protocol |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyStructure |
Element Textual Value | None |
Attributes | None |
Child Elements | (Description?, Arm*, Epoch*, WorkflowRef?) |
Usage/Business Rules |
|
(Description?, Arm*, Epoch*, WorkflowRef*) |
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.