FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

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4-6 June 2024
Munich, Germany

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The U.S. Food and Drug Administration (FDA) published the final Q&A paper on a risk-based approach to monitoring of clinical trials.
According to the agency, the purpose of the guidance is to provide recommendations on implementing a risk-based approach to monitor investigational studies on human drugs, biologics, medical devices, and combinations products. It expands on FDA's 2013 guidance for industry "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring" with additional recommendations to facilitate and encourage sponsors to implement risk-based monitoring. 

Background

Sponsors must monitor their clinical investigations, but they have flexibility in how to do it. FDA believes risk-based monitoring can allow sponsors to identify and address issues that could affect processes that protect human research participants and clinical trial integrity during clinical investigations.  

The new guidance thus focuses on the agency´s recommendations for

• planning a monitoring approach,
• developing content for monitoring plans, and
• addressing and communicating results from monitoring.

Revisions to the draft guidance included changes made in response to public comments that requested clarification of some of FDA's recommendations for planning and implementing risk-based approaches to monitor clinical investigations.   

More information can be found in the final guidance for industry, "A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers".