Understanding FDA’s Risk-Based Approach to Monitoring of Clinical Investigations

Posted in Process Improvement

The FDA recently released “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry,” which provides updated recommendations on how sponsors of clinical trials should approach risk-based monitoring activities. The FDA’s guidance emphasizes a risk-based approach to monitoring with monitoring efforts focused on areas with the highest potential risk to patient safety and data integrity. This approach allows sponsors to allocate their resources efficiently and effectively, ensuring that monitoring activities are tailored to the specific risks associated with each clinical trial.

The guidance outlines the principles of risk-based monitoring, including the identification of critical data and processes, the assessment of potential risks, the establishment of risk tolerance levels, and the development of a monitoring plan. Once critical data and processes are identified, sponsors should assess potential risks associated with these elements. Risks can arise from various sources, such as the study design, the investigational product, the study population, and the study conduct. Sponsors should evaluate the likelihood and impact of these risks on patient safety and data integrity to determine the level of monitoring required.

The guidance emphasizes the importance of establishing risk tolerance levels, which are predetermined thresholds that sponsors use to determine the need for monitoring. Risk tolerance levels should be based on the severity of the potential risk, the quality of the data being collected, and the robustness of the study processes. Based on the risk assessment and risk tolerance levels, sponsors should develop a monitoring plan tailored to the specific risks and needs of each trial and should include the rationale for the chosen monitoring approach, the frequency and intensity of monitoring, the responsibilities of the monitoring team, and the documentation requirements. The guidance also emphasizes the use of centralized monitoring techniques, such as statistical algorithms and data analytics, as part of the risk-based approach to monitoring. These techniques can help sponsors identify trends, patterns, and outliers in the data, which can be indicative of potential risks or data quality issues.

In conclusion, the FDA’s “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” provides valuable recommendations for sponsors on how to optimize clinical trial monitoring. By adopting a risk-based approach, sponsors can efficiently allocate their resources to areas with the highest potential risk, ensuring patient safety and data integrity while improving the overall efficiency of clinical trial monitoring. By establishing risk tolerance levels, developing a tailored monitoring plan, and utilizing centralized monitoring techniques, sponsors can implement effective monitoring strategies that align with regulatory expectations and best practices in clinical research.

Want to learn more? WCG Avoca Quality Consortium (AQC) members can visit the Risk-Based Quality Management – Quality by Design area of the Knowledge Center to access the many relevant tools available, including: 

AQC members are invited to join the discussion at the next Risk-Based Quality Management CoLAB meeting by registering through the Meeting Calendar.

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Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

Published: May 2023