In this webinar, FDA discusses the new draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations - Questions and Answers, released in March 2019. FDA will also review the importance of a risk-based approach to clinical trial monitoring and how to provide feedback on this draft guidance.
Recorded on April 1, 2019.
Ansalan Stewart, Ph.D.
Health Science Policy Analyst
Division of Clinical Trial Quality
Office of Medical Policy (OMP) | Center for Drug Evaluation and Research (CDER) | FDA
- Sponsors of clinical trials
- Contract research organizations
- Clinical trialists
- Clinical trial site staff
- Foreign regulators
- Consultants servicing the clinical trial enterprise
For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
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