Sponsors' Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

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Webinar Presenters

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Soo Bang, Sr. Director, Business Development & Global Alliances, Celgene Corporation
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences across different sponsor organizations in implementation of central IRB model for multi-centered clinical trials

Webinar Agenda

  1. Introduction: CTTI Use of Central IRBs for Multi-center Clinical Trials Project and Recommendations
  2. Sponsors’ role in choosing to use a central IRB for multi-center clinical trials
  3. One biopharmaceutical sponsor’s approach for adapting to new paradigm for IRB review in the U.S.
  4. A federal sponsor's experience of using a single central IRB for clinical trial networks
  5. Questions and Discussion