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 1 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, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.
Clinical trials vary widely in scale, complexity and cost. Careful evaluation of the priorities involved in each trial and the risks associated with the priorities 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. This guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.
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 is intended to provide information on how the principles can be appropriately applied to clinical trials. Additional annexes may be developed to respond to stakeholder needs 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.