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A reference to ItemGroupRef references an ItemGroupDef as it occurs within a specific FormDefStudyEventDef or ItemGroupDef. The list of ItemGroupRefs identifies the types of item groups that are allowed to occur within this type of formstudyevent or (nested) item group. The ItemGroupRefs within a single FormDef StudyEventDef or ItemGroupDef must not have duplicate ItemGroupOIDs nor OrderNumbers.
The OrderNumbers provide an ordering on the ItemGroupDefs (within the containing FormDef) for use whenever a list of ItemGroupDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness.
The Mandatory flag indicates that the clinical data for an instance of the containing form would be incomplete without an instance of this type of item group. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.
ItemGroupOID or OrderNumber attribute values.
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