Course Description

Having inadequate written procedures continues to be one of the most commonly cited findings for institutional review boards (IRBs) during the FDA’s Bioresearch Monitoring (BIMO) inspections. Both the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations state that IRBs must follow written procedures for their functions and operations to protect the rights and welfare of human subjects. This web seminar will review the FDA’s Final Guidance on IRB Written Procedures to include a Written Procedures Checklist that incorporates the HHS and FDA regulatory requirements for written procedures for the IRB and recommendations on the type of operational details to support each of these requirements.

Learning Objectives

• Discuss the background of the guidance
• Identify the required and suggested elements of Written Procedures
• Review the key similarities and differences in HHS and FDA requirements
• Consider the process for development and review of Written Procedures

Who Should Attend

• Clinical Research Associates
• Project Managers
• Clinical Investigators
• Clinical Research Coordinators
• Regulatory Affairs Professionals
• Institutional Officials
• Institutional Review Board Members and Administrators
• Academic Medical Center and Research Institution staff supporting clinical research
• Personnel responsible for ensuring compliance with Good Clinical Practice (GCP) regulations

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Registration Fees

$735

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: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 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#: 0778-0000-21-043-L04-P. Released: 7/21. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.