Training and Continuing Education
-
Guidance Webinar: Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring
The draft guidance Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, issued in August 2011 and presented on 24 October 2011 from 11 a.m. to 12 p.m. EST as part of the Critical Path Initiative's Guidance Webinar series, is 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The draft guidance encourages sponsors to use a variety of approaches, including centralized monitoring methods, as they fulfill their responsibilities of monitoring investigator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, slides, transcript, and questions taken from the audience at this 24 October Guidance Webinar.
-
Guidance Webinar Video, Transcript, Audience Questions
-
-
-
