Abstract
The environment of clinical trial for new drug development in our country is stagnating in quality and quantity due to acceptance of foreign clinical data and strengthening of restrictions (new GCP) and other reasons, and it is an urgent issue to activate clinical trials. The Ministry of Health, Labour and Welfare and the Ministry of Education, Culture, Sports, Science and Technology (MECSST) were planning an activation of clinical trials. Under this program, they have promoted training of clinical trial coordinators at medical organizations with cooperation of the Japan Medical Association, and construction of a large-scale trial network connecting multiple medical institutions. Its results have been gradually recognized, but clinical trials still cost several times higher than in the West. In order to improve this situation, it is imperative to construct a thorough system from electronic patient records as a source of information through clinical trials, and to realize more efficient, high quality and inexpensive clinical trials. This is a report of our development of a system that ensures security and authenticity of not only electronic patient records but also data among databases of laboratories, Contract Research Organizations (CROs), physicians, pharmacists, nurses and many other specialists, by integrating electronic authentication and electronic signature through the Web technology and Healthcare Public Key Infrastructure (HPKI).
