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Comment: Per ODM-13, requirement and cardinality are part of the parent element's list of child elements

StudyParameter elements are referenced from Workflow elements.

Requirement
  • Conditional: required if one of more StudyParameter elements is referenced as part of a Workflow.
    • Cardinality: One or more
    Element NameStudyParameter
    Parent ElementsStudySummary
    Element XPath(s)

    /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter

    Element Textual ValueNone
    Attributes

    OID, Term, ShortName

    Child Elements(ParameterValue, Coding*)
    Usage/Business Rules