Expert Meeting

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

CTTI Project: Single IRB

Meeting Location

DoubleTree by Hilton Hotel Silver Spring, 8727 Colesville Rd., Silver Spring, MD

 

CLICK HERE for the meeting brief.
CLICK HERE for the meeting agenda.
CLICK HERE for a list of the meeting attendees.

Meeting Objectives:

  • Review upcoming NIH policy and Common Rule changes regarding single IRB review as well as existing FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials.
  • Discuss the remaining gaps in knowledge, guidance and tools for implementing a single IRB review model.
  • Propose solutions regarding implementation of single IRB model for federally funded (e.g., NIH-sponsored), and for FDA-regulated drug and device, multicenter clinical studies.

Meeting Presentations:

  1. Introduction to CTTI and the Single IRB Project by Sara Calvert
  2. NIH Single IRB Policy by Petrice Brown-Longenecker
  3. Changes to the Common Rule for Single IRB by Lyn Lau
  4. FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials by Bridget Foltz
  5. Resources from the CTTI Single IRB Projects by Cynthia Hahn
  6. SMART IRB Platform Overview by Petra Kaufmann
  7. SMART IRB Exchange NIH Trial Innovation Network by Emily Serdoz
  8. AAHRPP Proposed Single IRB Review Standard by Robert Hood