Explore the 2024/2025 Edition of Barnett’s GCP Q&A Reference Guide

The 2024/2025 edition of Barnett’s Good Clinical Practice (GCP) A Question & Answer Reference Guide is a must-have resource for clinical compliance professionals. With over 500 pages of expert insights and more than 1,500 questions answered, this guide provides essential, up-to-date direction on GCP and evolving regulatory expectations.

Edited by Donna Dorozinsky, CEO & Founder of Just in Time GCP, the latest edition includes a dedicated chapter on Risk-Based Quality Management (RBQM)—a timely addition, especially as the clinical trial landscape shifts in response to ICH E6(R3).

What Makes the RBQM Chapter Stand Out

To add even more value, the RBQM chapter is authored by Keith Dorricott, Director of Dorricott Metrics & Process Improvement. It delivers clear, real-world guidance on how sponsors and CROs can:

• Implement RBQM effectively
• Enhance compliance
• Boost trial efficiency
• Align with ICH E6(R3)

Recently, Keith and Donna sat down to discuss this chapter’s insights.
👉 Watch the full video here

Key Takeaways from the RBQM Chapter

1. What Is Risk-Based Quality Management (RBQM)?

RBQM has been gaining traction in clinical trials for years. Now, with ICH E6(R3) emphasizing risk-proportionate approaches, implementing RBQM is more critical than ever.

The chapter:

• Defines RBQM as a trial-wide strategy
• Aligns RBQM with Quality by Design (QbD)
• Emphasizes prioritizing resources based on actual risk, not uniform scrutiny

Bottom line: RBQM helps protect participants and maintain data integrity by focusing attention where it matters most.

2. Four Pillars of an Effective RBQM Strategy

To implement RBQM successfully, organizations must focus on four key components:

• Risk Assessment – Identify critical-to-quality factors (CQFs) early
• Risk Control – Develop and continuously update mitigation strategies
• Risk Review – Manage risk as an ongoing process
• Risk Communication – Share decisions across teams, vendors, and regulators

3. Overcoming RBQM Adoption Challenges

Despite growing awareness, RBQM adoption still presents several hurdles. The chapter highlights:

• Terminology Confusion – RBQM, RBM, and QbD are often misunderstood
• Lack of Standardization – Different approaches make alignment difficult
• Regulatory Expectations – Sponsors must now document risk oversight clearly, especially under ICH E6(R3)

4. The Role of Documentation & the TMF

Documentation is critical under ICH E6(R3). The chapter explains how to:

• Include risk assessments in the Trial Master File (TMF)
• Demonstrate a clear risk management process—inspectors will expect to see how risks were identified and managed
• Ensure data integrity and retention, with over 50+ essential record categories now outlined in E6(R3)

5. What’s Next for RBQM and Clinical Compliance?

The chapter closes with a forward-looking view on RBQM’s growing influence:

• Standardization is coming—industry alignment is necessary
• Technology will play a bigger role—real-time tracking and centralized monitoring are key
• Proactivity is essential—risk management must become part of the trial design process, not just a compliance checkbox

Final Thoughts

Risk-Based Quality Management (RBQM) is more than a regulatory expectation—it’s a smarter way to conduct trials. It ensures that:

• Participant safety is protected
• Data remains credible
• Operations run efficiently

ICH E6(R3) places even more emphasis on risk-based, quality-focused strategies, and this chapter provides the tools to meet those demands.

👉 Barnett’s 2024/2025 GCP Q&A Reference Guide, with the RBQM chapter by Keith Dorricott and Donna Dorozinsky, is a valuable resource for anyone looking to improve compliance and drive trial success.