Systems Implemented by Sponsors to Assure Conduct of Clinical Trials in Compliance with Japanese GCP

Abstract

The systems implemented by a sponsor for conducting clinical trials in accordance with Japanese good clinical practice (GCP) are presented from the planning stage to the new drug application (NDA) stage. Special attention is given to the sponsor's internal organization for review of clinical trial plans, selection of medical institutions/investigators, monitoring, and review of case report forms and final reports, as well as auditing. Major problems in quality assurance are discussed from the standpoint of the sponsor. Some of the differences in the Japanese GCP and draft International Conference on Harmonization (ICH) GCP are also discussed.