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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

Body:

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Attributes:

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Contained in: StudyEventData

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Clinical data for an item group (record). The model supports nested and repeating item groups (for example, when several previous hospitalizations are reported in one history), or within reference data.

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    • are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent.

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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.

Multiple Selection Using Nested ItemGoupDef

    • The model supports nested and repeating item groups.

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