[FDA 2013, p11].
How to apply these strategies?
- Identify critical data and processes
- Perform a risk assessment to identify and understand the risks that could affect the collection of critical data or the performance of critical processes
- Develop a monitoring plan that focuses on the important and likely risks to critical data and processes.
Thus, inferring from the FDA guidance we get the first definition of the RbM from the FDA point of view:
RbM – is the adequate mix of strategies including centralized and on-site monitoring practices with the goal of human subject protection and trial integrity.
EMA sets the scope wider than the FDA and speaks in its reflection paper about risk based quality management (not only about monitoring), where the quality is defined as “fitness for purpose”. It opens a discussion about the new ways how to facilitate the existing quality practices, requirements and standards with the new risk-based approach. It opposes two ways of trial management: a reactive (fire-fighting approach) versus a preventive one. It claims that the aim of the RbM is “protecting trial subjects’ rights, well-being, integrity and safety and the assurance of quality of data and the trial results”.
In conclusion, the EMA definition of the RbM can be summarized as follows:
RbM is an important part of a preventive clinical trial management approach, which aims to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle in order to guarantee the protection of trial subjects’ rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility.
Summing up, there is definitely a semantic difference in scope of risk-adaptive approach and its improvement between EMA and FDA. Nevertheless, there is no significant differences in instructions and purposes. FDA puts focus on optimization of monitoring component, EMA speaks about the proactive approach in whole trial management. The reason of the difference in scopes is probably because it is not a path description, just a direction.
EMA, Nov 2013. Reflection paper on risk based quality management in clinical trials [WWW Document]. URL http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
FDA, Aug 2013. Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring [WWW Document]. URL http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf
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