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The def:SupplementalDoc element contains a DocumentRef for each supplemental document. Typically for a SDTM submission, there will be a reference to the Study Data Reviewers Guide; for an ADaM submission, there will be a reference to the Analysis Data Reviewers' Guide. 

Element NameSupplementalDoc

MetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/SupplementalDoc
Element Textual ValueNone
AttributesNone
Child Elements(DocumentRef+)
Usage/Business Rules
  • Business Rule(s):
    • If multiple documents are provided, there will be multiple DocumentRef child elements within the SupplementalDoc element.

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