Background
The FDA announced a public workshop to be held on July 17, 2019 entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”. The workshop was convened by Duke University’s Robert J. Margolis, MD, Center for Health Policy and further details on the agenda can be found here.
These slides where part of Session 3: Analytical Tools and Methods to Support Risk-Based Monitoring.
Slides
Watch a recording of the workshop here: (The recording is nolonger available from Duke Margolis - if I can find a new version it will be posted soon)
Further Reading On This Topic
- In 2013, the FDA released guidance for industry entitled “Oversight of Clinical Investigations - A Risk Based Approach to Monitoring”.
- In 2018, the ICH GCP guidance on Good Clinical Practice (ICH E6 R2) was updated with inclusion on the topic of central monitoring and integrating risk-based approaches into quality management systems. This is a unified standard for the EU, Japan, and United States.
- In 2019, the FDA released draft guidance for industry, to expand on the earlier guidance, entitled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers”.
- The 1997 guidance ICH E8 (R1) General Considerations For Clinical Studies contains guidance on identifying factors critical to study quality.