60222 Challenges and Risk Management for Investigator-Initiated FDA-IND Clinical Trials

Course overview

Discussion about the challenges of and risk management for investigator initiated Food and Drug Administration Investigational New Drug (FDA-IND) clinical trials. Topics include the application process to start clinical trials through the FDA-IND, communication between the FDA, funding agencies, and the Institutional Review Board (IRB), and follow-up IND reports. It also discusses how to recognize challenges and risk management in investigator-initiated trials, and the problem-solving experience in investigator-initiated IND studies.