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Comment: Moved business rules to the attributes table
Element NameItemGroupData
Parent ElementsClinicalData, ReferenceData, StudyEventData
Element XPath(s)

/ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData

/ODM/ReferenceData/ItemGroupData

/ODM/ClinicalData/ItemGroupData 

Element Textual ValueNone
AttributesItemGroupOID, ItemGroupRepeatKey, TransactionType, ItemGroupDataSeq
Child Elements(ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, Query*)
Usage/Business Rules
  • Business Rule(s):
    • The ItemGroupRepeatKey is present only if the ItemGroupDef is repeating.
    • PROPOSED BUSINESS RULE (Jozef): ItemGroupDataSeq may only be used when ItemGroupData is a direct child of either ClinicalData or ReferenceData and the ItemGroupData represents a row in a dataset.

    • ItemGroupData can also occur as reference data. In that case, the ItemGroupOID and ItemGroupRepeatKey pair must be unique within the reference data.

    • The ItemGroupDataSeq and ItemGroupRepeatKey attributes are mutually exclusive.
  • Other Information:
    • The ItemGroupOID and ItemGroupRepeatKey attributes are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent.
    • The ItemGroupDataSeq attribute doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset.
    • The model supports nested and repeating item groups.