ICH E6 Guideline Revision Fact Sheet

ICH E6 guideline revision fact sheet

The ICH E6, Good Clinical Practice (GCP): Consolidated Guideline 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. 

The hope is to enable implementation of innovative approaches to better ensure human subject protection and data quality. This paper outlines the proposed changes.

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