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An electronic signature applies to a collection of clinical data. This indicates that some user accepts legal responsibility for that data. See 21 CFR Part 11. The signature identifies the person signing, the location of signing, the signature meaning (via the referenced SignatureDef), the date and time of signing, and (in the case of a digital signature) an encrypted hash of the included data.
. Contrast with AuditRecord, and ds:Signature.
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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