Versions Compared

Old Version 3

changes.mady.by.user Lex Jansen

Saved on

compared with

New Version 4

changes.mady.by.user Marcelina Hungria

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Per ODM-13, moving notes to the element and attributes tables; adjusted wording to refer to Type='Form' ItemGroupDef.
Element NameReferenceData
Parent Element(s)ODM
Element XPath(s)

/ODM/ReferenceData

Element Textual ValueNone
UsageOptional
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.