Checklist for GCP compliance investigation (Medical institution)

Abstract

This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). This checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.