How To Prepare For ICH E6(R3) GCP When You're Still Struggling With (R2)

By Sheri Jacobsen, Jamie Chalfin, and Caitlin Schuler

The initial edition of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline was completed in 1996, defining the roles and expectations of all involved in clinical trials, including investigators, sponsors, and Institutional Review Boards. GCP encompasses trial initiation, monitoring, reporting, and record-keeping, incorporating guidance on Essential Documents and the Trial Master File.

ICH guidelines are instrumental in ensuring the safety, quality, and adherence to the intended use of biotech and pharmaceutical products during their entire lifecycle. ICH E6 specifies the standards for Good Clinical Practices (GCP) in trials, prioritizing human participant safety, data accuracy, and credibility. Health Authorities in each country enforce these standards through national regulations.

The ICH E6 GCP Guideline underwent revisions in 2016 to promote more efficient and effective clinical trial practices while maintaining human subject protection and data reliability. It introduced standards for electronic records and essential documents, aiming to enhance trial quality and efficiency.

In 2022, sponsors are still adapting to the revisions, with the release of a draft revision (R3) in March 2021, posing additional challenges before addressing (R2) expectations. In this blog post, the authors provide strategies to confidently navigate the new revisions.