A variety of distinctive ethical, regulatory, and legal challenges stand in the way of greater adoption of decentralized clinical trial (DCT) components and study designs.

As technologies rapidly evolve, the research community collectively lacks a common understanding of how best to ensure participant protection in ways permitting DCTs to flourish.

To help the community address these challenges and align on approaches, Medable and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) convened thought leaders to develop IRB review recommendations.

Join this webinar for a discussion of the working group’s findings and practical tips for better DCT implementation and oversight.

• Describe decentralized elements of key interest to IRB reviewers
• Summarize ethical and operational considerations for sponsors and sites
• Improve the way participants understand and engage with DCT tools and approaches

• Presenters

Barbara E. Bierer

MD

Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School

Leanne Madre

JD, MHA

VP of Evidence & Best Practices, Medable

Luke Gelinas

PhD

Senior IRB Chair Director, Advarra