Getting Started with Audit Trail Review in Clinical Trial Data: An Essential Guide

A Presentation by Jennifer Logue Nielsen - A Senior Specialist, Clinical Data Management, Lundbeck at the ACDM: Association for Clinical Data Management - Risk Based Quality Management Symposium 2024 at Brussels, Belgium.

At the recent ACDM RBQM Symposium in Brussels, Jennifer Nielsen delivered a compelling session on the importance of Audit Trail Review (ATR) in clinical trials. She emphasized the growing role of ATR in ensuring compliance and data integrity, particularly as regulatory requirements like MHRA guidance, EMA directives, and ICH GCP6 continue to evolve. Here's a brief recap of the key takeaways:

Why ATR Matters

ATR is critical for tracking and verifying every change made to clinical data throughout a trial. While regulators like the MHRA and EMA have emphasized the importance of audit trails since 2018, many organizations are still in the early stages of embedding ATR into their processes. According to Nielson, "We're just scratching the surface," six years after the initial guidelines.

Regulatory Guidelines and Metadata Review

Jennifer discussed the upcoming ICH GCP6 updates, which will require not just data review, but systematic metadata review. This means that organizations need to start thinking about how to audit their entire data ecosystem, not just individual changes. She suggested that companies incorporate ATR into their existing processes rather than creating new workflows.

Practical Considerations for ATR Implementation

Jennifer outlined several practical steps for getting started with ATR:

1. Risk Assessment: ATR should be part of your overall Risk-Based Quality Management (RBQM) strategy.

2. Vendor Collaboration: During CRO/vendor selection, ATR requirements must be documented and included in contracts and RFPs.

3. Technology Adoption: Leverage AI and machine learning to make ATR more efficient, particularly for identifying patterns across trials.

Challenges and the Future of ATR

One of the biggest challenges Jennifer highlighted is the gap in ATR adoption across different data types, such as ePRO or lab data. She encouraged organizations to collaborate cross-industry to standardize metadata, making it easier to use AI tools for ATR.

The call to action here? Start small, with use cases that bring immediate value, like tracking changes to primary endpoints. As she pointed out, "This is not going away—ATR is a regulatory expectation."

Final Thoughts

As ATR becomes more integral to clinical trials, organizations need to ensure they're audit-ready at every stage. Whether you're still learning about ATR or already embedding it into your processes, Jennifer Nielsen's insights provide a strong foundation for navigating this critical aspect of clinical trial data management.

How are you incorporating ATR into your clinical trials? Are you ready for the regulatory shift? Let’s discuss!

For those who may not already know - eClinical Solutions recently released an out-of-the-box Audit Trail Review, Fraud Detection capabilities in elluminate.

Check out this 4mins demo video: ATR & Fraud Detection: Short Demo Video

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