The StudyParameter element allows to provide a set of study design parameters such as anticipated number of subjects, minimum and maximum age of the participants, or planned number of arms.

Container element for StudyParameter elements referenced as part of a Workflow.
Element NameStudySummary
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary

Element Textual ValueNone
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.

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