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A general note about clinical data. If an annotation has both a comment and flags, the flags should be related to the comment.

Element NameAnnotation
Parent Elements ReferenceData, ClinicalData, SubjectData, StudyEventDataItemGroupData, ItemDataAssociation
Element XPath(s)
  • /ODM/ReferenceData/Annotation
  • /ODM/ReferenceData/ItemGroupData/Annotation
  • /ODM/ReferenceData/ItemGroupData/ItemData/Annotation
  • /ODM/ClinicalData/Annotation
  • /ODM/ClinicalData/ItemGroupData/Annotation
  • /ODM/ClinicalData/ItemGroupData/ItemData/Annotation
  • /ODM/ClinicalData/SubjectData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation
  • /ODM/Association/Annotation
Element Textual ValueNone
AttributesSeqNum, TransactionType
Child Elements(Comment?,  Coding*,  Flag*)
Usage/Business Rules

AttributeSchema Datatype or EnumerationUsageDefinitionsBusiness Rule(s)
SeqNumpositiveIntegerRequiredUniquely identifies the annotation within its parent entity.
TransactionType(Insert | Update | Remove | Upsert | Context)OptionalIndicates the insertion, update, removal of the annotation when it differs from the implied transaction for it's parent entity.
  • An empty Annotation (one with no annotation value, no comment and no flags) is not allowed unless the TransactionType is Remove.
  • On Update, the entire value of the annotation is replaced.

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