Audit Trail Section
An Audit Trail section focuses on the traceable record of data creation and changes: who or what changed information, when, and—where required—why. It is narrower than a full Computerized Systems section and should not be used as a substitute for broader system controls.
An Audit Trail section explains how creation and changes to electronic trial records remain traceable and reviewable without obscuring the original information.
Key details
Important caveats
Scope Boundary
Audit-trail controls are one part of computerized-system and data-governance requirements. Do not imply that an audit trail alone establishes overall system validation, security, or data quality.
Further guidance
Content
State which systems or records use audit trails, what events and metadata are captured, how audit trails are protected and retained, and when review is expected according to risk and applicable procedures.
Purpose
Make change history reconstructable so data review and oversight can distinguish original entries from later modifications.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification
- E6(R3) Good Clinical Practice (GCP) — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current FDA final-guidance overview for ICH E6(R3), including quality by design, risk-based quality management, technology, proportionality, and clarified sponsor/investigator responsibilities