APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

• Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
• Discuss research findings among experts present at the meeting
• Solicit additional feedback to refine proposed solutions

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

• Introduction to the Clinical Trials Transformation Initiative (CTTI) by Judith M. Kramer
• Origin of the Project, "Use of Central IRBs for Multi-center Clinical Trials" by Jane Perlmutter*
• Results of Literature Review by Devon Check*
• Early Interviews with Experts by Kathryn Flynn*
• Interviews to Obtain Feedback on Proposed Solutions - Rational for "Considerations Document" by Kevin Weinfurt*