CTN webinar: Research 101 session 2: FDA basics & essential regulatory compliance

This is the second session in a series titled “Research 101,” which will provide basic education about doing clinical research.

This webinar outlines the basics of FDA oversight and reviews other essential regulatory activities to successfully keep a study in compliance, including ongoing management and reporting requirements. The regulatory portion reviews essential regulatory activities, such as IRB approvals and informed consent requirements. Lastly, there is a discussion of current challenges and best practices when working on regulatory compliance.