Provides Metadata for signatures included in the /ODM/ClinicalData.
| Element Name | SignatureDef |
|---|---|
| Parent Elements | AdminData |
| Element XPath(s) |
|
| Element Textual Value | None |
| Attributes | OID, Methodology |
| Child Elements | (Meaning, LegalReason) |
| Usage/Business Rules |
|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier. |
|
| Methodology | (Digital | Electronic) | Optional | Defines the type of electronic signature, including the meaning as required by 21 CFR Part 11. |
|
Example: SignatureDef
SignatureDef
<SignatureDef OID="SIG.001" Methodology="Digital">
<Meaning>Meaning of the signature</Meaning>
<LegalReason>Legal reason of the signature</LegalReason>
</SignatureDef>