Monthly Archives

June 2017

ICH E6 R2: Waiting and Watching no Longer an Option When it Comes to Risk-Based Monitoring

By | Blog | No Comments

As is typical of our industry, despite ringing endorsements of Risk-Based Monitoring (RBM) from both the FDA and EMA back in 2013, researchers have been conservative with respect to adopting this proven approach as standard within their clinical trials.

However, the introduction of ICH E6 R2 this year means that waiting and watching is no longer acceptable.…