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Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
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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.
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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.
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OrganizationOID | oidref | Optional | Reference to an Organization elment. | - Must match the OID attribute for an OrganizationDef element within this AdminData element.
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LocationOID | oidref | Optional | Reference to a Location element. | - Must match the OID attribute for an OrganizationDef element within this AdminData element.
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