Data Safety Committees: What Are They And When Are They Needed?


Data Safety Committees: What are They and When are they needed?


On August 11, 2016, Edward Liechty, MD gave a presentation on the importance of data safety committees. The video of the presentation can be accessed with the link above. The presentation is approximately 31 minutes long and is followed by approximately 22 minutes of discussion.

Additional Resources:

Translational Research Ethics Consultation Service (TREX)


FDA guidance for data safety and monitoring committees

NIH guidelines for data safety and monitoring committees

DeMets, D. L., & Ellenberg, S. S. (2016). Data monitoring committees—expect the unexpected. New England Journal of Medicine, 375(14), 1365-1371.

IU Center for Bioethics | 410 W. 10th St., Suite 3100 | Indianapolis, IN 46202 | Tel: 317-278-4034 | Fax: 317-278-4050