ICH GCP E6 R3

Aug 23 , 2024

ICH E6(R3) Guideline

1 I. INTRODUCTION

2 Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the

3 conduct of trials that involve human participants. Clinical trials conducted in accordance with

4 this standard will help to assure that the rights, safety and well-being of trial participants are

5 protected; that the conduct is consistent with the principles that have their origin in the

6 Declaration of Helsinki; and that the clinical trial results are reliable. The term “trial conduct”

7 in this document includes processes from planning to reporting, including planning, initiating,

8 performing, recording, oversight, evaluation, analysis and reporting activities as appropriate.

9 The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual

10 acceptance of clinical trial data for ICH member countries and regions by applicable regulatory

11 authorities.

12 This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for

13 Clinical Studies. This includes fostering a quality culture and proactively designing quality into

14 clinical trials and drug development planning, identifying factors critical to trial quality, and

15 engaging stakeholders, as appropriate, using a proportionate risk-based approach.

16 Clinical trials vary widely in scale, complexity and cost. Careful evaluation of the priorities

17 involved in each trial and the risks associated with the priorities will help ensure efficiency by

18 focusing on activities critical to achieving the trial objectives.

19 Guideline Scope

This guideline applies to interventional clinical trials of investigational products 1 20 that are

21 intended to be submitted to regulatory authorities. This guideline may also be applicable to

22 other interventional clinical trials of investigational products that are not intended to support

23 marketing authorisation applications in accordance with local requirements.

24 Guideline Structure

25 This ICH GCP Guideline is composed of principles and annexes that expand on the principles,

26 with specific details for different types of clinical trials. The principles are intended to apply

27 across clinical trial types and settings and to remain relevant as technological and

28 methodological advances occur. The principles outlined in this guideline may be satisfied using

29 differing approaches and should be applied to fit the intended purpose of the clinical trial.

30 Annex-1 is intended to provide information on how the principles can be appropriately applied

31 to clinical trials. Additional annexes may be developed to respond to stakeholder needs and to

32 address emerging innovations in trial design and conduct. This guideline should be read in

33 conjunction with other ICH guidelines relevant to the design and conduct of clinical trials,

34 including multiregional trials.