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Element NameSignature
Parent Element(s)ItemDataItemGroupDataStudyEventDataSubjectData,StudyEventData,ItemGroupData,ItemData
Element XPath(s)
  • /ODM/ClinicalData/SubjectData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemData/Signature
Element Textual ValueNone
Usage

Required for Archive and Transactional Data Exchange use cases. 

Must reflect use of electronic signatures in the source system.

AttributesNone
Child Elements(UserRefLocationRefSignatureRefDateTimeStamp)


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