October 31 2019 Heather Paden, MS

In recent years, efforts to streamline clinical research activities while improving subject safety and data integrity have included risk based monitoring (RBM). As recently as May 2019, the International Council for Harmonisation (ICH) proposed revisions to its General Considerations for Clinical Studies (E8) guideline. Section 3 of E8 (R1) stresses the importance of managing the quality of safety measures and data collection as part of an entire Quality Plan in a clinical program and its studies. This effort is called Risk-Based Quality Management (RBQM).

On Thursday, October 31st, the FDA held a public meeting organized by the ICH entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Studies.” The purpose of the meeting was to provide information and solicit input from a broad range of non-ICH members, observers and other stakeholders (including patient advocates) on the draft revised E8(R1) Guideline. The FDA want us to “stop calling it Risk-Based Monitoring and call it Risk-Based Quality Management – it’s not just about monitoring, it is an end to end process.”  During the public meeting it was stressed that these are new guidances to change the way we are doing clinical research, not a new set of regulations to sit on top of current ones. These are really intended to change how we are doing research by implementing “quality by design” .

How are RBM and RBQM related? The quality by design approach to clinical research involves focusing on factors critical to quality to ensure the protection of subjects, the generation of reliable and meaningful results, and the management of risks to those ends. 

How do we design quality into clinical studies and clinical development programs? Clinical program teams need to identify factors critical to quality by proactive, cross-functional discussions and decision making at the time of study concept and design. This step includes identification of critical data and processes, as well as identification and evaluation of risks during protocol development. After protocol finalization, RBM directs monitoring focus and activities to the evolving areas of greatest need; those that have the most potential to impact subject safety and data quality.

RBM includes risk control, review and reporting. Thus, RBQM is a critical strategy in clinical research that when introduced at the beginning stages of the project and implemented throughout the lifetime of the project, will lead to improved subject safety, higher data quality, and more meaningful clinical trial results.


Risk Based Quality Management is not just about monitoring, it is an end to end process.

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