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changes.mady.by.user Sally Cassells

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changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, bullets on Usage/Business Rules
Element NameSignature
Parent
Element(s)ItemData, ItemGroupData, StudyEventData, 
ElementsReferenceData, ClinicalData, SubjectData,StudyEventData,ItemGroupData,ItemData
Element XPath(s)
  • /ODM/ReferenceData/Signature
  • /ODM/ReferenceData/ItemGroupData/Signature
  • /ODM/ReferenceData/ItemGroupData/ItemData/Signature
  • /ODM/ClinicalData/Signature
  • /ODM/ClinicalData/ItemGroupData/Signature
  • /ODM/ClinicalData/ItemGroupData/ItemData/Signature
  • /ODM/ClinicalData/SubjectData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Signature
Element Textual ValueNone
AttributesNone
Child Elements(UserRef, LocationRef, SignatureRef, DateTimeStamp)
Usage/Business Rules
  • Business Rule(s):
    • Required for Archive and Transactional Data Exchange use cases where an electronic signature is required.
 
    • For ODM ClinicalData generated by an EDC  or ePRO system the signatures must reflect the
Must reflect
    • use of electronic signatures in the source system
.AttributesNone
    • .
    • A Signature cannot be modified.
      • When clinical data changes, new signatures may be added.
  • Other Information:
    • A Signature applies to data at a particular point in time.
    • A Signature applies to the entire contents of the entity, not just the content that is mentioned in the current ODM element.
    • A Signature applies to (static) content, not to a change in content.
Child Elements(UserRef, LocationRef, SignatureRef, DateTimeStamp)