ou could hear the “Aha!” moment in the room. The conference delegates and members of the panel had come to a realization. One of the reasons why the implementation of Risk-Based Quality Management (RBQM) is so difficult: everyone does it differently. The international guidance in ICH E6 (R3) is very high level, and organizations have taken many varied approaches.

• Sponsors find that each CRO they go to implements RBQM in a different way, making it difficult to integrate and oversee.
• CROs find that each sponsor wants them to run RBQM their way, which means their staff are having to regularly switch between very different RBQM processes and systems.

The differences go beyond terminology into areas that really impact the effectiveness of RBQM such as the link between Critical to Quality Factors (CTQs) and risks, whether risks can be accepted, use of Key Risk Indicators, integration of issue management, and so on. In an environment of ever-increasing outsourcing of services, this leads to real inefficiencies and confusion and is a systemic risk in itself.

As discussion of these topics continued around the SCOPE Europe conference in Barcelona last year, an idea began to take shape. A volunteer group of experienced RBQM professionals from sponsors, service providers, and consultants agreed to meet regularly to discuss these challenges and to publish guidance and tools online for the industry. A well-known RBQM service provider offered to sponsor us, and so we launched the mindsON RBQM Expert Working Group (EWG) in 2025 to focus on assisting the industry and improving together.

We decided our aim was to help provide guide rails and emerging best practices. The first consideration was to assess the publicly available information from industry consortia in this area and to consider the gaps where the EWG could potentially add the most value for the industry. We saw a clear gap: Oversight of RBQM. With the recent adoption of ICH E6 (R3), there can be no doubt that regulators expect the industry to implement a risk-proportionate approach to all clinical trials. Where RBQM is outsourced to a service provider such as a CRO, it is also clear that the overall responsibility remains with the sponsor as stated in ICH E6 (R3) 3.6.6: “…the ultimate responsibility for the sponsor’s trial-related activities, including protection of participants’ rights, safety and well-being and reliability of the trial data, resides with the sponsor.” In addition, ICH E6 (R3) 3.9.5 states that “the range and extent of oversight measures should be fit for purpose and tailored to the complexity of and risks associated with the trial.” Oversight of RBQM itself, then, should be implemented in a risk-proportionate way. It should not be just about checking that SOPs are in place, reports are received in a timely way, and so on. But what should this oversight look like?

The aim of the EWG in this area was to develop a framework to assist organizations with RBQM oversight by drawing on members’ experience and expertise. There is little publicly available guidance in this area, and yet it is very important. If RBQM is implemented ineffectively and this is not recognized and corrected, risks will not be appropriately managed, and there may be significant negative consequences to participant safety, well-being, and rights, and/or to data reliability. This is why the regulators are constantly encouraging a risk-proportionate approach – because the industry is still not fully there.

What is RBQM Oversight?

The initial question the EWG focused on was “What is RBQM oversight?” The EWG agreed that RBQM oversight is about ensuring that risks to quality are actively managed. The starting point of a risk-proportionate approach is determining what is critical for trial success; i.e., the CTQs. It then looks to analyze the risks to those CTQs and track and control those risks. RBQM oversight, therefore, needs to constantly assess whether the CTQs need to be modified and the associated risks have been identified and are being tracked and controlled.

As RBQM oversight must be fit for purpose, the level of oversight should vary between trials and even during trials. A pivotal trial, use of a new service provider for a critical aspect of the trial, and/or adding new geographies to a trial are examples of where RBQM practice will be important for trial success, and so RBQM oversight will likely need to be more intense. During a trial, evidence may emerge that an increased, or a diminished, level of RBQM oversight is required.

So, what is the outcome from the EWG discussions? They have resulted in some initial assets that will be useful in assisting the industry in RBQM oversight, whether the trials are internally managed or are outsourced. We plan to make these available to the industry for free downloading by the early 2026:

• An article describing our thinking on and providing practical guidance for RBQM oversight.
• An RBQM Oversight Level Matrix which can be used to assess specific criteria such as “Sponsor Experience” and “Process & Systems Novelty” and to provide a guide on the intensity of oversight needed for a trial. Suggested mitigations for each of the criteria are included to help develop effective RBQM oversight.
• Reflection Questions and Sample Responses that can help probe the RBQM process both prior to implementation and during a trial. Example questions:
  • “Is there evidence of a study-specific risk assessment plan for the trial?”
  • “Has the risk assessment been revisited after protocol changes or as the trial progresses?”

The EWG is mindful of the guidance in ICH E8 (R1) on quality culture in organizations. These initial assets should be used in the spirit of critical thinking and open, proactive dialogue rather than as providing a fixed result or as a checklist.

We look forward to the next “Aha!” moment—and to seeing how new collaborations can further strengthen RBQM across the industry.