| 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. |
Overview
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