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changes.mady.by.user Marcelina Hungria

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changes.mady.by.user Lex Jansen

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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.