| Element Name | Signature |
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| Parent Elements | ReferenceData, ClinicalData, SubjectData,StudyEventData,ItemGroupData,ItemData |
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| 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
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| Element Textual Value | None |
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| Attributes | None |
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| Child Elements | (UserRef, LocationRef, SignatureRef, DateTimeStamp) |
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| 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 use of electronic signatures in the source system.
- 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.
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