[Present situation and future subjects of N.SAS study--based on experience of managing data center]

The "National Surgical Adjuvant Study" (N-SAS) was established as a study group on carcinostatics on the market as part of the Ministry of Health and Welfare's 1995/1996 consignment project. Patient registration started in October 1996, and later it was restructured as a consignment study by Taiho Pharmaceutical Co., Ltd. in April 1997. It still continues to date. EPS Co., Ltd. has operated the "N.SAS Data Center" to conduct three clinical trials of N.SAS study. In the following, we analyse the current situation and subjects of N.SAS study from the viewpoint of the data center, recognising the necessity of infrastructure at medical institutions while complying with enforcement of newly GCP and GPMSP. First, the organization and function of N.SAS, and the role and position of data center on N.SAS study, are explained. Some notes are introduced from conducting In-house Monitoring on N.SAS, especially methods and formation of communicating information between N.SAS Data Center and institutions. We also propose an infrastructure which will be essential for smooth promotion of long-term and large-scale trials like the N.SAS study.