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Container element for StudyParameter elements referenced as part of a Workflow.

Usage/Business Rules
Element NameStudySummary
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary

Element Textual ValueNone
  • Conditional: The StudySummary element is required as a container element if one or more StudyParameter elements is referenced as part of a Workflow.
Attributes

None

Child Elements(StudyParameter*)+)
Usage/Business Rules
  • Other Information:
    • Detailed metadata about arms and epochs, visits and other study events that are used by the workflow are provided under StudyStructure.