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.