The long-anticipated revised version (R3) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH GCP E6) introduces important changes to clinical research, especially in academic settings. Now that most of the revised guideline has entered into force in Switzerland, clinical research professionals are grappling with what these changes mean in practice. In order to help the research community navigate these developments, Regulatory Affairs Watch’s editorial team compiled a series of questions and turned to swissethics for its perspective. This exchange highlights how core principles of ICH GCP E6(R3) are interpreted and applied in Switzerland as well as how evolving requirements intersect with institutional realities. Moreover, swissethics addresses practical considerations such as documentation, investigator qualifications, and the use of interactive tools to enhance participant understanding. This article aims to provide clinical research professionals with a clear, actionable overview of swissethics’ key expectations following the revision of ICH GCP E6.
Pietro Gervasoni (Mon,) studied this question.
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