| Element Name | User |
|---|---|
| Parent Element(s) | AdminData |
| Element XPath(s) | /ODM/AdminData/User |
| Element Textual Value | None |
| Usage | Conditional. For each vUserRef/@UserOID value in an AuditRecord or Signature element in the Clinical Data there must be a User element with a matching OID attribute. |
| Attributes | OID, UserType, OrganizationOID |
| Child Elements | (UserName?, Prefix?, FullName?, GivenName?, FamilyName?, Image?, Address*, Telecom?, OrganizationRef*, LocationRef*) |
Body:
| (UserName?, Prefix?, FullName?, GivenName?, FamilyName?, Image?, Address*, Telecom?, OrganizationRef*, LocationRef*, Certificate (Deprecated)*) |
Attributes:
| 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. |
Contained in:
Information about a specific user of a clinical data collection or data management system. This may be an investigator, a research subject, a care provider, a study monitor, data management or data analytics staff. A user can be a member of more than one organization, work or enter data at different locations. In the case of studies that include patient reported outcomes, the user may be a study subject and/or their care-giver.