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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
  • 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 model supports nested and repeating item groups.

AttributeSchema Type or Enumeration ValuesUsageDefinitionBusiness Rule(s)
ItemGroupOIDoidrefRequiredReference to an ItemGroupDef for the MetaDataVersion identified in the ClinicalData element.
  • The values of ItemGroupOID must be unique within the parent element.
ItemGroupRepeatKeyrepeatKey

Conditional

  • Required when the Repeating attribute for the ItemGroupDef element is "Yes".
A key used to distinguish between repeats of the same type of item group.
  • The values of ItemGroupRepeatKey must be unique within the parent element.
  • The ItemGroupRepeatKey is present only if the ItemGroupDef is repeating.
  • For /ODM/ReferenceData/ItemGroupData, the ItemGroupOID and ItemGroupRepeatKey pair must be unique.
TransactionTypeInsert | Update | Remove | Upsert | Context

Conditional

  • Required when the FileType attribute for the ODM element is Transactional.
The TransactionType attribute need not be present in a Snapshot document.
ItemGroupDataSeqpositiveInteger

Conditional

  • Required when the parent element is ReferenceData or ClinicalData, the ItemGroupDataSeq.

Unique sequence # for each ItemGroupData child element (record) in the container element.

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.

  • 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.
  • The ItemGroupDataSeq and ItemGroupRepeatKey attributes are mutually exclusive.



Clinical data corresponding to an ItemGroupRef defined in the active MetaDataVersion. 

The ItemGroupOID and ItemGroupRepeatKey are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent. The ItemGroupRepeatKey is present if and only if the ItemGroupDef is repeating.

The ItemGroupDataSeq 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.

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

The model supports nested and repeating item groups.

Example

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