An AuditRecord carries information pertaining to the creation, deletion, or modification of clinical data. This information includes who performed that action, and where, when, and why that action was performed.

AuditRecord information describes a change to clinical data, but is not itself clinical data. The value of some clinical data can always be changed by a subsequent transaction, but history cannot be changed, only added to.

Element NameAuditRecord
Parent ElementsReferenceData, ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData, Query
Element XPath(s)
  • /ODM/AdminData/Location/Query/AuditRecord
  • /ODM/ReferenceData/AuditRecord
  • /ODM/ClinicalData/AuditRecord
  • /ODM/ClinicalData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/AuditRecord
  • /ODM/ClinicalData/SubjectData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Query/AuditRecord
Element Textual ValueNone
Usage/Business Rules
  • Business Rule(s):
    • For the Archive use case, all AuditRecord information in the data collection system must be provided within the ODM ClinicalData.
    • When the ODM FileType attribute is set to Transactional, every ClinicalData that has a TransactionType must also have an AuditRecord.
  • Other Information:
    • An AuditRecord applies to any descendant data element that allows a TransactionType and does not have an AuditRecord.  Query elements must have their own AuditRecord(s).
    • AuditRecord information describes a change to clinical data, but is not itself clinical data. The value of some clinical data can always be changed by a subsequent transaction, but history cannot be changed -- only added to.
AttributesEditPoint, UsedMethod.
Child Elements(UserRef, LocationRef, DateTimeStamp, ReasonForChange?, SourceID?)

AttributeSchemaType or Enumeration ValuesUsageDefinitionBusiness Rules
EditPoint(Monitoring | DataManagement | DBAudit)OptionalIdentifies the phase of data processing in which update action occurred.
  1. The monitoring phase includes any data collection and correction involving the clinician, study-site personnel, or study monitor.
  2. The data management phase includes any changes made for internal data processing reasons (for example, coding or updating derived data) and before database lock.
  3. The DB audit phase occurs after database lock.
UsedMethod(Yes | No)OptionalIndicates that the action was made by the system rather than a data entry form user action.The value No indicates the change was made through the system user interface. The value Yes indicates the change was made through an  automated process or workflow.

« Value

UserRef »

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