Audit trail

An audit trail is a record of activities, actions, and changes made within a clinical trial’s data. It serves to track and document any modifications, additions, or deletions to ensure data integrity, compliance with regulatory requirements, and transparency. The audit trail provides a detailed history of data alterations and the identity of the individuals responsible for those changes.

Regulatory definitions

ICH E6 (R3)

Metadata records that allow the appropriate evaluation of the course of events by capturing details on actions (manual or automated) performed relating to information and data collection and, where applicable, to activities in computerised systems. The audit trail should show activities, initial entry and changes to data fields or records, by whom, when and, where applicable, why. In computerised systems, the audit trail should be secure, computer-generated and time stamped 1.

Implementation

Audit trails may be maintained in paper or electronic records. In paper records, entries and subsequent changes may be documented by dated and signed corrections, while electronic systems generally record changes automatically with information about the user and date and time of the action.

Audit trail review provides evidence of how clinical trial data were entered and modified and allows changes to be traced to identified individuals and events.

References

  1. International Council for Harmonisation. 2026. ICH E6(R3): Consolidated Guideline for Good Clinical Practice.
    Available at: https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf ↩︎