The International Council on Harmonisation (ICH) has released the first two parts of a long-awaited third revision to ICH E6 – Good Clinical Practice and invited public comment on the draft that would replace and expand on the current GCP guideline, ICH E6(R2).

The 73-page guideline, which the council has been developing since 2019, is intended to update GCP principles and practices in response to recent years’ developments in clinical trials, including new trial designs, technologies and methods (CenterWatch Weekly, Nov. 1, 2021).

The document consists of six pages covering basic principles and an annex that addresses the responsibilities of IRBs, investigators and sponsors as well as guidance on managing data contained in computerized systems. A second annex on innovative trial designs and the use of real-world data is still being drafted and may be available for public comments as soon as March 2024.

Interested parties should submit comments to their national regulatory agency (e.g., the FDA in the U.S., the European Medicines Agency in the EU) or directly to the ICH Secretariat at step2comments@ich.org. Comments submitted to the Secretariat should use the ICH Excel template.

Read the E6(R3) draft guideline here: https://bit.ly/439Av3B.