Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredBusiness 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.
OrganizationOIDoidrefOptionalReference to an Organization elment.
  • Must match the OID attribute for an OrganizationDef element within this AdminData element.
LocationOIDoidrefOptionalReference to a Location element.
  • Must match the OID attribute for an OrganizationDef element within this AdminData element.