抄録
At present, development work for new drugs is demanded on accompanying pressing needs in the medical world. Clinical trials for new drugs as the latest products may increase gradually in medical facilities based on new GCP, and we must correspond to them with flexibility, though probably influenced by different quantity and quality in clinical trials. In our University Dental Hospital, the office-work division and pharmaceutical services play roles with different duties as to treatment fees and management of drug storage, respectively. This must be surely based between contract workers and corresponding clients for clinical trials. For the execution of practical use, a committee composed of members of the institutional review board (IRB), who must be practically working, including two members chosen from outside, and moreover its office, were established also in our Hospital in 1999. In addition, a cooperation system organized by clinical research coordinators (CRC) was set up to maintain safe and suitable responsibility of clinician's activity, and we also made up a guideline for standard procedures concerning clinical trials of new drugs.
Our aim is to build up a system for clinical trials of new drugs and medical management based on new GCP. Furthermore, we aim continually to improve clinical trials in the future.
