Why are we Seeing More Independent Data Safety Monitoring

Overview: It is important to see what the FDA regulations and the ICH GCP recommendations are in regard to DMC's. Most importantly, when does an adverse event (AE) or string of AE's lead to changes in a study protocol or even discontinuation of a study. Why should you Attend: With the increasing requirements for a DMC oversight it behooves all involved to know the set-up and function of these committees. Forewarned is forearmed.