This course examines the evolution of the Institutional Review Board and how current events are shaping its future and that of the conduct of clinical research. Special attention is given to how IRBs can develop internal systems that assist in meeting their regulatory obligations of protecting human research participants in response to new requirements.
Attendees will learn how the role of the IRB has changed since the regulations that govern them were codified and how clinical research professionals, institutions, and regulatory agencies have adapted to secure compliance while keeping pace with the changes in clinical research industry. Primary attention will be given to examination and development of Quality Systems within the Institutional Review Board and their positive impact on meeting the demands for regulatory compliance and the protection of human research subjects. The content is appropriate for any professional working with IRBs that review, approve, and oversee clinical investigations regulated by the FDA.
Explain the regulations, agencies, and guidance that govern IRB composition and function
Compare and contrast the IRB model of past and present and how IRBs have adapted to meet their objectives
Identify the new and proposed regulations, guidance, and legislation and the impact on IRB function and operation
Discuss current IRB-specific compliance concerns and how they impact on Good Clinical Practice standards for Principal Investigators, Sponsors, and Contract Research Organizations (CROs)
Implement methods for developing and/or assessing a proactive, risk-based human research protection program
Utilize corrective and preventative action plans and other tools to detect and deter noncompliance
Describe how regulatory authorities inspect and assess IRBs, their current findings, and proper responses
Define Quality Improvement (QI) and explore how to leverage it to help fulfill IRB responsibilities
Examine how the IRB’s approach to the protection of human research participants intersects and differs from those of other key clinical research team members
This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, or others involved in site and IRB assessment and/or selection, Clinical Investigators, Study Coordinators, IRB Members, IRB Professionals, Institutional Officials involved in oversight of clinical research, and GCP-Focused Regulatory Affairs Professionals working with IRBs that review, approve, and oversee clinical investigations regulated by the FDA
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
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Day 1: 8:30 a.m. – 5:00 p.m.
- The Role of IRBs in Clinical Research: Established and Evolving
- New Developments and Emerging Trends in IRB Oversight and Function
- Scandal and Scrutiny: Current Compliance Concerns and the “Ripple Effect”
Day 2: 8:30 a.m. – 5:00 p.m.
- Operational Quality Systems for the IRB: Format for Compliance
- Regulatory Authority Inspections and Assessments: Current Focus and Processes
- Using Risk Management Assessments and Quality Improvement as Tools for Securing Compliance
Critical Review of Regulatory and Industry Documents
Assessment of Corrective and Preventative Action Plans and Responses
FDA Mock Audit/Inspection Exercise
Problem Solving Scenarios
Group Discussions of Best Practices
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-044-L04-P. Released: 11/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.