ICH E6(R3) requires sponsors to perform risk-based, timely, and focused audit trail reviews as part of quality oversight. The goal: ensure the integrity and reliability of critical trial data by reviewing meaningful changes, deletions, or anomalies—always in proportion to risk and integrated into data management processes.

Key Points on Audit Trail Reviews in ICH E6(R3)

1.Audit Trails Must Be Reviewable and Meaningful
Capture who, what, when, and why for critical data. Logs must be accessible and human-readable.

2.Focus on Critical Data
Reviews should prioritize endpoints, eligibility, and other risk-heavy data—not every entry.

3.Timely and Periodic Review
Conduct reviews proactively and at key trial points, not just once.

4.Integration with RBQM
Use centralized monitoring to spot patterns and trigger deeper audit trail checks.

5.Document Reviews
Transparency in process and findings supports inspection readiness.

6.System Validation & Access Control
Audit trails must be tamper-proof, validated, and restricted to authorized staff.

How to Get Started with Audit Trail Reviews

1.Identify critical data points.

2.Map systems and confirm access.

3.Assess audit trail capabilities.

4.Define a risk-based review strategy.

5.Develop SOPs or work instructions.

6.Create a review template.

7.Train your team.

8.Pilot the process.

9.Integrate with data cleaning and monitoring.

10.Document everything.

BioGRID’s Role in Smarter Audit Trail Review

BioGRID was designed to make audit trail review simple, focused, and inspection-ready. With advanced automation and visualization, it helps sponsors:

• Perform risk-based, targeted reviews aligned with ICH E6(R3)
• Detect anomalies and trends faster
• Generate clear, inspection-ready reports

Learn more about how BioGRID supports smarter audit trail oversight: www.biogridsolutions.com