Preparing for the Revised Good Clinical Practice Guideline – ICH GCP (R3)

Preparing for the Revised Good Clinical Practice Guideline – ICH GCP (R3)

What is Good Clinical Practice?

The International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline (ICH GCP) is a globally recognised, ethical, scientific, and quality standard for conducting clinical trials. It sets the responsibilities and expectations of sponsors, investigators, and all other professionals involved in designing, conducting, monitoring, recording, and reporting of clinical trials. Complying with the guideline helps to ensure that the rights, safety, and well-being of participants are protected, and that the trial data and results are reliable.

The current guideline (ICH E6(R2)) is available here.

Updates to the ICH GCP Guideline

The ICH GCP guideline is currently undergoing a major renovation. This is a huge event in the clinical trials space! A draft of the newly revised guideline (R3) was released in May 2023. It resembles a restructured and heavily expanded version of R2. The draft is organised as follows:

  • I – Introduction
  • II – Principles of ICH GCP
  • III – Annex 1 (interventional clinical trials)
  • Glossary
  • Appendices

The revised guideline (R3) draft is available here.

This draft is still in the public consultation stage. Comments from regulatory agencies around the world are due in over the next couple of months. Once this stage is complete, work on a new section, Annex 2, will begin. This section will cover additional considerations for non-traditional interventional clinical trials. Development of the Annex 2 draft is expected to take approximately 12-18 months.

Updates to our ICH GCP Training Course

As a provider of ICH GCP training, we are keeping a close watch on the renovation and have been reviewing the currently available draft R3 guideline. We are preparing for a major revision of our online training course, which we aim to update in a timely manner once the complete revised guideline (R3) has been approved.

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