In November 17, 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries to address some of major developments in technology, medical breakthroughs and business processes – taking into account unprecedented yet justified expectations by regulators, patients, investigators and caregivers.

The eCF webinar explored what was removed and discussed some of the opportunities and challenges presented by additions to the E6 text:

• How to eliminate sponsor control over Investigator entries/Source data? Where did the contemporaneous investigator copy go and should we forget all about it?
• How to develop and document risk-based approaches to monitoring in order to protect reliability of trial results (Data Integrity)? How to develop monitoring plans which describe the strategy, methods, responsibilities, and requirements for monitoring the trial?
• CSV formally makes its way into GCP in a more prescriptive manner than ever before – too late, too little?

Slides used during the event can be downloaded by eCF members from the Members area of the website.