| Element Name | SignatureDef |
|---|---|
| Parent Element(s) | AdminData |
| Element XPath(s) |
|
| Element Textual Value | None |
| Usage | Required if the ODM ClinicalData includes any Signature Elements. |
| Attributes | OID, Methodology |
| Child Elements | (Meaning, LegalReason) |
Body:
Attributes:
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier. | Must be unique within a Study. |
| Methodology | (Digital | Electronic) | Optional | Defines the type of electronic signature, including the meaning as required by 21 CFR Part 11. | If the signature is Digital, it is based on cryptography. Otherwise the signature is Electronic. |