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changes.mady.by.user Sally Cassells

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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
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.