FDA and OHRP Requirements for the Preparation and Maintenance of IRB Meeting Minutes
Institutions and institutional review boards (IRBs) are responsible for oversight of human subject research under HHS and FDA regulations. As part of meeting this responsibility, IRBs must prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. Unfortunately, IRBs have routinely been cited in OHRP Determination Letters and FDA Warning Letters for failing to prepare and maintain adequate minutes. In this web seminar, we will discuss the FDA and OHRP Joint Guidance on Minutes of IRB Meetings recommendations and the responsibilities of institutions and IRBs in the preparation and maintenance of minutes of IRB meetings to ensure compliance with regulatory requirements.
- Discuss common noncompliance issues and top IRB findings from FDA BIMO inspections
- Describe the purpose of minutes and meeting minute content requirements
- Review expectations for documenting attendance, actions, vote, modifications and/or disapproval, and resolution of controverted issues
Who Should Attend
- Clinical Research Associates
- Project Managers
- Principal Investigators
- Clinical Research Coordinators
- Regulatory Affairs Professionals
- Institutional Officials
- Institutional Review Board Members and Administrators
- Academic Medical Center and Research Institution Professionals supporting clinical research
- Personnel responsible for ensuring compliance with GCP regulations
Elizabeth Ronk Nelson, M.P.H.
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: firstname.lastname@example.org
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-21-027-L04-P. Released: 4/21.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.