I. INTRODUCTION TO ICH E6 (R3) Guideline on good clinical practice (GCP) Step 5

ICH HARMONISED GUIDELINE
GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5

23 January 2025
EMA/CHMP/ICH/135/1995
Committee for Human Medicinal Products

Date for coming into effect 23 July 2025

Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable. The term “trial conduct” in this document includes processes from planning to reporting, including planning, initiating, performing, recording, oversight, evaluation, analysis and reporting activities as appropriate.

The objective of this ICH GCP Guideline 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.

This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, engaging interested parties, as appropriate, and using a proportionate risk-based approach.

Clinical trials vary widely in scale, complexity and cost. Careful evaluation of critical to quality factors involved in each trial and the risks associated with these factors will help ensure efficiency by focusing on activities critical to achieving the trial objectives.

Guideline Scope

This guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities. The Principles of GCP in this guideline may also be applicable to other interventional clinical trials of investigational products [1] that are not intended to support marketing authorisation applications in accordance with local requirements.

The Annexes provide the basis for the appropriate interpretation and application of the principles and should therefore be appropriately considered; however, various approaches to the provisions in the Annexes may be considered provided they are justified and achieve the intended purpose of the application of the principles.

This guideline encourages a risk-based and proportionate approach to the conduct of a clinical trial.

Guideline Structure

This ICH GCP Guideline is composed of Principles and Annexes that expand on the principles, with specific details for different types of clinical trials. The principles are intended to apply across clinical trial types and settings and to remain relevant as technological and methodological advances occur. The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial.

Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials. Additional annexes may be developed to respond to the needs of interested parties and to address emerging innovations in trial design and conduct. This guideline should be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials, including multiregional trials.

[1] For the purpose of this guideline, the term “investigational products” should be considered synonymous with drugs, medicines, medicinal products, vaccines and biological products.

Author: © European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.

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