SDAC: Selected DMC Charter and Background Material

Industry-Modified NIH MOdel
Original NIH Model - Clinical Trials

The role of an Independent Statistical Analysis Center in the Industry-Modified National Institutes of Health Model by Fisher, Roecker, and DeMets. Drug Information Journal 35:115-129, 2001.

Data Monitoring Committees: Lessons, Ethics, Statistics Study Group A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 365:711-22, 2005

Guidance for Clinical Trial Sponsors on The Establishment and Operation of Clinical Trial Data Monitoring Committee issued March 2006.

Sample DSMB Charter (based on Diabetes Control and Complications Trial)

Additional Information

Jeanne McCabe
Clinical Trials Program Manager