The quality assurance and quality control issues for sponsors on GCP compliance in Japan

✍ Scribed by Kouichi Inoue; Saburo Hasebe

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 101 KB
• Volume: 3
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199806)3:2<65::aid-qaj63>3.0.co;2-r

✦ Synopsis

Implementing and maintaining quality assurance (QA) and quality control (QC) systems for clinical trials is essential for sponsors to assure the integrity and reliability of clinical trials and the data obtained from clinical trials. The main points of the revised Good Clinical Practice (GCP) in Japan are the abolition of the chief investigator, the clarification of responsibility of the sponsor, stipulated in the provisions for preparing standard operating procedures (SOPs) for QA and QC systems, monitoring by way of source data verification, and auditing. These provisions imply that the sponsor is ultimately responsible for conducting and managing clinical trials, and the sponsor's activities must be supported by elaborate SOPs, intensive training and education of the monitors, and extensive consensus on the auditing method must be pursued by auditors.