Serve On Boards To Review And Monitor Clinical Trials
Tips for Success
- Build strong, positive relationships with pharmaceutical companies and other potential Sponsors early in the therapy development process to ensure your patient community is represented in the DSMB.
- Work with your Scientific/Medical Advisory Board as well as researchers focused on your disease to learn more about the IRB process at their respective institutes.
- Encourage your Scientific/Medical Advisory Boards and researchers to serve on their own institutional IRBs.
- Introduce Sponsors to your Scientific/Medical Advisory Board as well as other known specialists for your disease and select members of your patient community to potentially increase the expertise on the DSMB.
- Communicate the protections that IRB and DSMB provide participants of clinical trials to your disease community.
Institutional Review Board
Guidance for Institutional Review Boards: Frequently Asked Questions – IRB Registration U. S. Food and Drug Administration (FDA) (link)
Guidance Document: Institutional Review Boards Frequently Asked Questions U. S. Food and Drug Administration (FDA) (link)
Recommendation on IRB Membership and Definition of Non-scientist Human Health and Services (HHS) Office of Human Research (link)
Data Safety and Monitoring Board
Guidance Document: Establishment and Operation of Clinical Trial Data Monitoring Committees U. S. Food and Drug Administration (FDA) (link)