| Element Name | Signature |
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| Parent | Element(s)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 - of electronic signatures in the source system.
The Signature applies to the clinical data element entity to which it is attached, to all clinical data included in the entity at the time of the signing. For the purpose of this definition, clinical data includes all attributes and element content except for TransactionType attributes. It includes Annotations but not Signature elements, or AuditRecord elements. Note: A - 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 cannot be modified. When clinical data changes, new signatures may be added.Note: 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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| Attributes | None |
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| Child Elements | (UserRef, LocationRef, SignatureRef, DateTimeStamp) |
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