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changes.mady.by.user Marcelina Hungria

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

Requirement:
  • Conditional: Required as a container element if one or more StudyParameter elements is referenced as part of a Workflow..
    • Cardinality: Zero or one.
    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.