Best Practices for IRB Review of DCTs: Expert Perspectives
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
Barbara E. Bierer
Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School
VP of Evidence & Best Practices, Medable
Senior IRB Chair Director, Advarra
Who should watch?
This content applies to IRB and HRPP professionals involved in reviewing research and overseeing IRB activities. It also applies to research professionals representing sponsors, CROs, and sites who are involved in the planning, development, and execution of clinical drug and device trials involving decentralized trial modalities.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour