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Information about a specific user of a clinical data collection or data management system.
| Element Name | User |
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| Parent Elements | AdminData |
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| Element XPath(s) | /ODM/AdminData/User |
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| Element Textual Value | None |
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| Attributes | OID, UserType, OrganizationOID, LocationOID |
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| Child Elements | (UserName?, Prefix?, Suffix?, FullName?, GivenName?, FamilyName?, Image?, Address*, Telecom*) |
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| Usage/Business Rules | - Business Rule(s):
- 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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| 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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