Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA

FDA’s regulations require sponsors to monitor the conduct and progress of their clinical investigations.

The regulations are not specific about how sponsors are to conduct such monitoring; therefore, a range of approaches to monitoring are compatible with the regulations. The RBM guidance discusses the importance of identifying critical data and processes necessary for human subject protection and integrity of the investigation, conducting a risk assessment, and developing a monitoring plan specific to the investigation. The RBM guidance also encourages sponsors to tailor monitoring plans to the needs of the investigation, describes factors to consider in developing a monitoring plan, and provides examples of monitoring methods and techniques.

FDA believes risk-based monitoring is an important tool to allow sponsors to identify and address issues during the conduct of clinical investigations. FDA’s experience since finalizing the RBM guidance in 2013 suggests that additional guidance would be beneficial regarding FDA’s recommendations for planning a monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results. The following questions and answers are intended to assist sponsors in planning and conducting risk-based approaches to monitoring

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A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry