In a recent Comprehend webinar, “Three Key Ways ICH E6 (R2) Impacts Study Oversight,” CGI’s (formerly Paragon) Karen McCarthy Schau outlined best practice reasons why Sponsors should focus on Study Oversight when addressing ICH E6 guidelines and the upcoming R2 addendum.
ICH E6 (R2) Focus
To frame the discussion, Ms. Schau pointed out three key statements from the addendum on which she would focus:
1. ..encourage implementation of improved and more efficient approaches to clinical trial[s]..
2. ..methods used to assure and control the quality of the trial should be proportionate to the risks..
3. ..the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.