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U.S. Department of Health and Human Services

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Guidance Webinars


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Guidance Webinar: Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring

On October 24, 2011, FDA presented a webinar on a new draft guidance entitled "Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring". The webinar was intended to assist sponsors in developing risk-based approaches to monitoring. 
In today’s increasingly complex clinical trial environment, key goals remain to enhance human subject protection while maintaining the high quality and integrity of clinical trial data. Reliable approaches to monitoring are critical, and although a variety of monitoring approaches are available for overseeing clinical trial conduct, the most common approach remains frequent visits to each clinical trial site.
The draft guidance encourages sponsors to use a variety of approaches, including centralized monitoring methods, as they fulfill their responsibilities of monitoring investigator conduct and the progress of investigational new drug (IND) or investigational device exemption (IDE) studies. The guidance reflects the growing consensus that risk-based approaches to monitoring will enable sponsors to monitor study conduct more effectively and efficiently.  

Listed below are the video and slides from this October 24th Guidance Webinar, as well as a link to the draft guidance.


Guidance Webinar Video and Slides