| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Business Rules | For each UserRef/@UserOID value in an AuditRecord or Signature element in the Clinical Data there must be a User element with a matching OID attribute. |
| UserType | (Sponsor | Investigator | Subject | Monitor | Data analyst | Care provider | Assessor | Lab | Other) | Optional | User's role in the study. | A user can be a member of more than one organization, work or enter data at different locations. For studies that include patient reported outcomes, the user may be a study subject and/or their care-giver. |
| OrganizationOID | oidref | Optional | Reference to an OrganizationDef elment. | Must match the OID attribute for an OrganizationDef element within this AdminData element. |
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