CTU Bern (Clinical Trials Unit)

ICH adopted the Integrated Addendum to the Good Clinical Practice (GCP) Guideline

On November 30th, 2016 the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the adoption of the Integrated Addendum to the Good Clinical Practice (GCP) Guideline E6(R2). ICH states that the “guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results”. The amendment will now be implemented by ICH members through national and regional guidance. The main changes by the amendment cover the following areas:

  • Perhaps the most significant change is the requirement to adopt risk management principles in a Quality Management System and in monitoring of a trial.
  • The amendment also includes the principle for sponsors to address detected significant non-compliance through root cause analysis, and prevention of reoccurrence (CAPA plan).
  • Clarifications regarding electronic data capture.
  • Enhanced oversight requirements for investigators and sponsors.

The updated guideline E6(R2) can be found here.

The CTU Lecture on 17.01.2017 will introduce the new addendum and the most important changes.