An electronic signature applies to a collection of clinical data. This indicates that some user accepts legal responsibility for that data. See . 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.
The Signature element provides a simple mechanism to state that the user accepts legal responsibility for that data. It should not be confused with an embedded XML-based electronic signature such as XML-Signature, which can be added through an extension ds:Signature element.
| Element Name | Signature |
|---|
| Parent Elements | ReferenceData, 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 Value | None |
|---|
| Attributes | None |
|---|
| 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 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.
|
|---|