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.