ICH GCP E6 R2

Aug 28 , 2024

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR

GOOD CLINICAL PRACTICE ICH

E6(R2)

INTRODUCTION

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for

designing, conducting, recording and reporting trials that involve the participation of human

subjects. Compliance with this standard provides public assurance that the rights, safety and

well-being of trial subjects are protected, consistent with the principles that have their origin

in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP Guideline is to provide a unified standard for the European

Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data

by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the

European Union, Japan, and the United States, as well as those of Australia, Canada, the

Nordic countries and the World Health Organization (WHO).

This guideline should be followed when generating clinical trial data that are intended to be

submitted to regulatory authorities.

The principles established in this guideline may also be applied to other clinical

investigations that may have an impact on the safety and well-being of human subjects.