May 15, 2023, 1:00 – 2:15 PM
Applying the FDA Framework in Conducting IRB Review
Virtual presentation co-presented by the UK Office of Research Integrity (ORI) and the UK Center for Clinical and Translational Science (CCTS)
Objectives:
Examine when an activity falls under FDA regulations.
Outline a step-by-step framework for applying FDA regulations in clinical investigations.