ICH E6 Guideline Revision Fact Sheet
The ICH E6, Good Clinical Practice (GCP) is being revised for the first time in 20 years. The revisions address the problem of changes to the scale and complexity of clinical trials, and ensure appropriate use of technology and a modern approach to GCP. This will enable implementation of innovative approaches to better e
nsure human subject protection and data quality.
This whitepaper outlines the proposed changes and how they will impact the clinical research landscape.