FDA Guidance on Risk-Based Monitoring of Clinical Trials
The FDA recently released a final version of the draft guidance entitled “Oversight of Clinical Investigations A Risk Based Approach to Monitoring.” The original draft version was the first to provide sponsor guidelines for monitoring a clinical study. The intent of the draft guidance was to assist clinical trial sponsors in developing risk-based monitoring strategies for clinical studies involving medical products and devices with the ultimate goal of improving human subject protection and the quality of clinical trial data. The main difference between the final and draft versions is that the language in the final version provides greater clarity and emphasizes factors pertaining to these issues.
Among the main points brought out in the final version of the guidance are:
1. Greater emphasis on a centralized risk-based monitoring system – New technology allows centralized monitoring of data quality and therefore monitoring is no longer restricted only to on-site monitoring.
2. Greater emphasis on the importance of good protocol design – “The most important tool for ensuring human subject protection and high-quality data is a well-designed and articulated protocol.” U.S. FDA
3. Greater emphasis on sponsor/CRO communication – When working with a Contract Research Organization, delegating monitoring to the CRO requires greater clarity, communication and follow up from the sponsor.
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