ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)

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.