| Element Name | SignatureDef |
|---|
| Parent |
|---|
Element(s)| Elements | AdminData |
|---|
| Element XPath(s) | - /ODM/AdminData/SIgnatureDef
- /ODM/Study/MetaDataVersion/MethodDef/FormalExpression
- /ODM/Study/MetaDataVersion/ConditionDef/FormalExpression
|
|---|
| Element Textual Value | None |
|---|
UsageRequired if the ODM ClinicalData includes any Signature Elements. | | Attributes | OID, Methodology |
|---|
| Child Elements |
|---|
(Meaning, LegalReason)Body:
...
| Usage/Business Rules | - Business Rule(s):
- Required if the ODM ClinicalData includes any Signature Elements
|
|---|
| 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