New version of ICH GCP Guideline E6(R3) on Good Clinical Practice
Background and objective
The GCP Guideline E6(R3) is a revision of the E6(R2) from 2016.
This update has been a long time in the making. In June 2019, the ICH Assembly endorsed the revision following the ICH reflection paper on GCP published in 2017. On 6 January 2025, the GCP E6(R3) reached Step 4 of the ICH process, adopting the principles and Annex 1.
The overall objective is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
The guideline builds on key concepts described in ICH E8(R1), including fostering a quality culture, proactively designing quality into clinical trials and drug development, engaging stakeholders, identifying factors crucial to trial quality and adopting a proportionate risk-based approach.
Key modifications - Principles, Annex 1 and Annex 2
The revision consists of, inter alia, (i) a new structure to provide clarity and better readability, (ii) greater emphasis on proportionality within a risk-based approach, (iii) new language to facilitate innovations in clinical trial design, technology and operational approaches, (iv) more detailed guidance on the informed consent process and data governance and (v) a reference to public involvement and trial diversity.
For example, as noted a new element is a proportional risk-based approach, which is reflected in principle no 7. This principle states, that clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected and that avoids unnecessary burden on participants and investigators.
Moreover, another update is a new section on data governance. This Section provides guidance to the investigator and the sponsor on, inter alia, the management of data integrity, such as in relation to blinding of data, and which key procedures the parties must follow to cover the full data life cycle.
A draft version of Annex 2 was endorsed on 6 November 2024 as Step 2 and is currently under public consultation. It encompasses further considerations and clarification of the scope of trials involved such as pragmatic and decentralized clinical trials and those using real-world data (RWD). The document is anticipated to be finalised as a Step 3 Sign off/Step 4 version and implemented in Mid-2025.
Additional annexes may be developed to address interested parties' emerging needs and innovations in trial design and conduct.
Upon completion, E6(R3) will consist of a general principles and objectives document, Annex 1 and Annex 2.
Read the ICH E6(R3) Step 4 Final Guideline incl. principles, Annex 1 and Appendices A-C
Read the ICH E6(R3) Annex 2 draft version
Read the ICH E6(R3) Concept Paper
Further information on the ICH Efficacy Guidelines can be found here
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