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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 ValueNoneUsage/Business Rules
AttributesItemGroupOID,  ItemGroupRepeatKeyItemGroupRepeatKey,  TransactionTypeTransactionType, ItemGroupDataSeq
Child Elements(ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, ItemData*, Query*

Attributes:

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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 TypeUsageDefinitionBusiness RulesItemGroupOIDoidrefRequiredReference to an ItemGroupDef for the MetaDataVersion identified in the ClinicalData element.ItemGroupRepeatKeyrepeatKeyConditionalA key used to distinguish between repeats of the same type of item group within a single form.When the Repeating attribute for the ItemGroupDef is "Yes" the ItemGroupRepeatKey must be unique within the parent element.TransactionType(Insert | Update | Remove | Upsert | Context)ConditionalThe TransactionType attribute need not be present in a Snapshot document.When the FileType attribute for teh ODM is Transactional, the TransactionType must be provided.ItemGroupDataSeqintegerConditionalUnique sequence # for each ItemGroupData child element (record) in the container element.When the parent element is ReferenceData or ClinicalData, the ItemGroupDataSeq must be provided
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