A reference to information about a specific user of a clinical data collection or data management system.

Element NameUserRef
Parent ElementsAuditRecordSignature
Element XPath(s)
  • /ODM/AdminData/Location/Query/AuditRecord
  • /ODM/ClinicalData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/AuditRecord
  • /ODM/ClinicalData/SubjecData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEvent/AuditRecord
  • /ODM/ClinicalData/SubjecData/StudyEvent/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEvent/ItemGroupData/AuditRecord
  • /ODM/ClinicalData/SubjecData/StudyEvent/ItemGroupData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEvent/ItemGroupData/ItemData/AuditRecord
  • /ODM/ClinicalData/SubjecData/StudyEvent/ItemGroupData/ItemData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEvent/Signature
  • /ODM/ClinicalData/SubjectData/StudyEvent/ItemGroupData/Signature
  • /ODM/ClinicalData/SubjectData/StudyEvent/ItemGroupData/ItemData/Signature
Element Textual ValueNone
AttributesUserOID
Child ElementsNone
Usage/Business Rules

AttributeSchema Type or Enumeration ValuesUsageDefinitionBusiness Rule(s)
UserOIDoidrefRequired Reference to the User definition.
  • Must match the OID attribute of an AdminData/User element. If used within a ClinicalData element, the  ClinicalData StudyOID attribute must match the StudyOID attribute in the the AdminData element.

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