IRB review of FDA-regulated research requires the interpretation and application of regulatory standards that are different from and often in addition to those of the Common Rule, including issues of continuing review, informed consent, and investigational new drugs/investigational device exemptions (INDs/IDEs). Understanding how these differences are tied to the unique mission of FDA can demystify the “why” behind the differing and additional regulatory requirements. By tying the regulatory criteria governing FDA-regulated research to an understanding of the agency itself, this webinar aims to provide participants with an accessible and memorable framework for IRB review of research subject to FDA oversight.
- What is FDA-regulated research?
- What is the mission of the FDA – and how is that different than the mission of OHRP?
- Examples of areas in which FDA and OHRP regulations differ and how mission difference explains regulatory differences
- Understand how to determine which studies are FDA-regulated
- Discuss the mission of the FDA and how it connects to the regulations
- Clarify the complexity of FDA requirements where the requirements differ from the Common Rule
This webinar will be beneficial to IRB members, IRB/HRPP staff, clinical research support personnel and others new to FDA-regulated research
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.
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HRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit thehrpconsultinggroup.com.