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changes.mady.by.user Sally Cassells

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changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, moving the Usage/Business Rules row to the end, to support moving notes to the element and attributes tables
Element NameStudySummary
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary

Element Textual ValueNone
Attributes

None

Child Elements(StudyParameter*)
Usage/Business Rules
  • Requirement:
    • Conditional:
    The StudySummary element is required
    • Required as a container element if one or more StudyParameter elements is referenced as part of a Workflow..
Attributes

None

    • Cardinality: Zero or one.
  • Other Information:
    • Detailed metadata about arms and epochs, visits and other study events that are used by the workflow are provided under StudyStructure.
Child Elements(StudyParameter*)