You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
« Previous
Version 3
Next »
Provides Metadata for signatures included in the /ODM/ClinicalData.
Element Name | SignatureDef |
---|
Parent Elements | AdminData |
---|
Element XPath(s) | - /ODM/AdminData/SIgnatureDef
- /ODM/Study/MetaDataVersion/MethodDef/FormalExpression
- /ODM/Study/MetaDataVersion/ConditionDef/FormalExpression
|
---|
Element Textual Value | None |
---|
Attributes | OID, Methodology |
---|
Child Elements | (Meaning, LegalReason) |
---|
Usage/Business Rules | - Business Rule(s):
- Required if the ODM ClinicalData includes any Signature Elements.
|
---|
Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
---|
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.
|