Implementing Risk-Based Quality Management: Insights from the Latest GCP Guide

The 2024/2025 edition of Barnett’s Good Clinical Practice (GCP) A Question & Answer Reference Guide is a comprehensive resource on clinical compliance, featuring over 500 pages of expert insights and answering 1,500+ questions related to GCP and regulatory expectations.

Part of this latest edition, edited by Donna Dorozinsky, CEO & Founder of Just in Time GCP, includes a dedicated chapter on Risk-Based Quality Management (RBQM)—a critical addition in light of the evolving clinical trial landscape and the finalization of ICH E6(R3). 

To provide deeper insights, this chapter—authored by Keith Dorricott, Director of Dorricott Metrics & Process Improvement—provides practical, real-world guidance on how sponsors and CROs can effectively implement RBQM to enhance compliance, improve trial efficiency, and align with the latest regulatory expectations.

Keith and Donna recently sat down to discuss this new chapter (you can access the full video here) and we’ve highlighted some key takeaways below.

What the RBQM Chapter Covers

1. Understanding Risk-Based Quality Management

RBQM has been a growing focus in clinical trials for years, but now, with ICH E6(R3) emphasizing risk-proportionate approaches, its implementation is now an even more critical part of GCP compliance.

The chapter begins by breaking down RBQM as a trial-wide strategy, highlighting its connection to Quality by Design (QbD) and its role in prioritizing resources based on risk. Instead of applying the same level of scrutiny to every aspect of a trial, RBQM ensures that attention is directed where it matters most for participant safety and data integrity.

2. Key Elements of an Effective RBQM Strategy

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

• Risk Assessment – Identifying critical-to-quality factors (CQFs) early in the trial planning process.
• Risk Control – Developing risk mitigation strategies and ensuring they are continuously updated.
• Risk Review – Treating risk management as an ongoing process that evolves as the trial progresses.
• Risk Communication – Ensuring that risk-based decision-making is effectively shared across teams, vendors, and regulatorss.

3. Challenges in RBQM Adoption

Despite being discussed for years, RBQM adoption still faces hurdles. Specifically, the chapter highlights several industry challenges, including:

• Terminology Confusion – Many struggle to differentiate RBQM, RBM (Risk-Based Monitoring), and QbD, leading to inconsistent implementation.
• Lack of Standardization – Sponsors and CROs often take different approaches, making alignment across teams and vendors difficult.
• Regulatory Expectations – Now that ICH E6(R3) emphasizes risk-proportionate oversight, sponsors and CROs must ensure structured documentation of risk assessments and mitigation efforts.

4. Documentation & the Trial Master File (TMF)

One of the most significant updates in ICH E6(R3) is its emphasis on essential records and data integrity. Regulatory inspections now focus on risk-based oversight, making proper documentation critical.  This chapter provides guidance on:

• Ensuring risk assessments are included in the TMF for compliance.
• Demonstrating a clear risk-management process—inspections will start with reviewing how risks were identified, mitigated, and monitored.
• Data integrity and long-term retention—with ICH E6(R3) outlining 5o+ categories of essential records, sponsors must ensure data security and accessibility for audits and regulatory review.

5. The Future of RBQM & Clinical Compliance

With ICH E6(R3) reinforcing risk-based approaches, RBQM will only become more deeply integrated into clinical research. The chapter explores:

• The push for industry standardization – Sponsors and CROs must align on risk-based frameworks to ensure consistency.
• The role of technology – Centralized monitoring and real-time risk tracking will be critical moving forward.
• The importance of a proactive approach – Instead of treating risk management as a reactive compliance task, organizations must embed it into their trial planning and execution strategies.

Final Thoughts

Risk-Based Quality Management (RBQM) is a critical component of modern clinical research, helping organizations focus on participant safety, data integrity, and trial efficiency. As ICH E6(R3) reinforces risk-proportionate approaches and Quality by Design (QbD), integrating these principles into clinical trial processes will improve compliance and streamline operations.

The new RBQM chapter, in Barnett’s 2024/2025 GCP Q&A Reference Guide authored by Keith Dorricott and edited by Donna Dorozinsky, provides essential insights into how to implement RBQM effectively under ICH E6(R3), making this book a valuable reference for anyone involved in clinical trials.