ICH Guideline E6 (GCP)

The ICH Guideline E6 (Good Clinical Practice, GCP) is an international ethical and scientific quality standard for planning, initiating, performing, recording, oversight, evaluation, analysis and reporting clinical trials involving human participants. It ensures the protection of participants’ rights, safety, and well-being while promoting the credibility and reliability of clinical trial data.

Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), E6 harmonizes GCP principles across regulatory regions, including Argentina, Brazil, Canada, China, Chinese Taipei, Egypt, the EU, Japan, Jordan, the Republic of Korea, Mexico, Saudia Arabia, Singapore, Switzerland, Türkiye, the United Kingdom, and the U.S.A. It provides guidance on trial protocols, sponsor and investigator responsibilities, informed consent, and monitoring practices.

ICH E6 is a cornerstone for clinical research, emphasizing compliance with principles that have their origin in the Declaration of Helsinki. By fostering international consistency, it facilitates mutual acceptance of trial data by regulatory authorities, streamlining drug development and ensuring high standards of safety and integrity.