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changes.mady.by.user Sally Cassells

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Comment: Per ODM-13, adjusted wording on Usage
Element Name
ItemGroupData
Association
Parent Elements
ClinicalData, ReferenceData, StudyEventData
ODM
Element XPath(s)

/ODM/

ClinicalData/SubjectData/StudyEventData/ItemGroupData

/ODM/ReferenceData/ItemGroupData

/ODM/ClinicalData/ItemGroupData 

Association 

Element Textual ValueNone
Usage/Business Rules
Attributes
ItemGroupOID, ItemGroupRepeatKey, TransactionType,ItemGroupDataSeq
StudyOID, MetaDataVersionOID
Child Elements
AuditRecord?, Signature?, Annotation*, ItemData*, Query*

...

(KeySet,
 
KeySet, Annotation)

Attributes:

...

Contained in:

...

Usage/Business Rules
  • Other Information:
    • The first and second KeySets child elements identify the start and end of the annotated "link."

...

    • The StudyOID and MetaDataVersionOID attributes provide a context for interpreting CodeList references within the Annotation. They do not affect the meaning of the KeySets.

...