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Element NameReferenceData
Parent Element(s)ElementsODM
Element XPath(s)

/ODM/ReferenceData

Element Textual ValueNone
AttributesStudyOID, MetaDataVersionOID
Child Elements(ItemGroupData* AuditRecord?, Signature?, Annotation*)
Usage/Business Rules
  • Other Information:
    • Implementation note: Because reference data can be independent of any particular study, it may be desirable to keep the reference metadata separate from clinical metadata. This can be done by creating a Study element with no Protocol, StudyEventDef, or Type="Form" ItemGroupDef elements. All other ItemGroupDefs elements would have IsReferenceData=Yes. Such a study would have no clinical data.