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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.

The SeqNum attribute (a small positive integer) uniquely identifies the annotation within its 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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Element NameAnnotation
Parent
Element(s)
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
UsageOptional
AttributesSeqNum, TransactionType
Child Elements(Comment?,
  
  Coding*,  Flag*)

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Usage/Business Rules