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A free-text (uninterpreted) comment about clinical data. The comment may have come from the sponsor or the clinical site.

Element NameComment
Parent ElementsAnnotation
Element XPath(s)
  • /ODM/ReferenceData/Annotation/Comment
  • /ODM/ReferenceData/ItemGroupData/Annotation/Comment
  • /ODM/ReferenceData/ItemGroupData/ItemData/Annotation/Comment
  • /ODM/ClinicalData/Annotation/Comment
  • /ODM/ClinicalData/ItemGroupData/Annotation/Comment
  • /ODM/ClinicalData/ItemGroupData/ItemData/Annotation/Comment
  • /ODM/ClinicalData/SubjectData/Annotation/Comment
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation/Comment
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation/Comment
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation/Comment
Element Textual Valuenone
AttributesSponsorOrSite
Child Elements(TranslatedText+)
Usage/Business Rules

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
SponsorOrSite(Sponsor | Site)OptionalSource of the comment.

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