As of April 2022, ICH E8(R1) is officially in effect. This is the first revision of ICH E8 since it was adopted in 1997, and sites, sponsors, and CROs need to move quickly to adjust to the new standards.
The revision of ICH E8 is the first step of ICH’s Good Clinical Practice Renovation project, which started in 2017 and continues with the third revision of ICH E6 (likely to be approved in 2022).
These revisions affect all clinical research professionals, but they’re especially significant for sponsors, CROs, or coordinating centers that run multicenter trials. Since ICH E8(R1) revolves around study design, you need a deep understanding of the new guidelines to create study protocols.
That’s why, with the help of our global compliance team, we put together this guide to ICH E8(R1). Check out our key takeaways for organizations that design protocols and run clinical trials.