10 February 2017

ICH E6(R1) on Good Clinical Practice (GCP) has been amended to encourage implementation of improved and more efficient approaches to clinical trials design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Following the adoption of the Integrated Addendum to the ICH E6 Guideline, a training presentation has been developed by the Expert Working Group.

Please now find on the E6(R2) page a presentation of the Integrated Addendum to GCP available for download.