| 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. |