[In order to perform clinical trials efficiently in Japan--important issues in medical institutions raised by the GCP on-site review].

The guidelines for Good Clinical Practice (GCP) in Japan have been harmonized with ICH-GCP. Both the protection of human rights and the carrying out of clinical trials ethically and scientifically, conforming to the GCP, are necessary for the safety and efficacy of clinical data of common technical documents. It is standard practice in Japan, the U.S., and the E.U. to ensure conformity with all data from raw data to application materials. In April, 2004, the new independent organization Pharmaceuticals and Medical Devices Agency (PMDA) was established in Japan. The PMDA provides services focusing on the three key areas of Review, Safety, and Relief. The Office of Conformity Audit is one of the offices in the Center for Product Evaluation of the PMDA. In the conformity audit service of the Office of Conformity Audit of the PMDA, the reliability and conformity with the GCP between case report forms (CRFs) as basis materials and application materials is confirmed by the document-based conformity review, and the conformity between medical records as raw data and CRFs is assessed through the on-site GCP review. Therefore, such application materials are considered to be consistent with international standards. The important issues raised by the GCP on-site review by the Office of Conformity Audit of the PMDA are summarized in this study. We hope that our findings at investigational sites will promote the protection of human rights and improve the quality of clinical trials in Japan.