薬理と治療

Abstract

The Clinical Trials Act became effective on April 1, 2018, as a result of several scientific misconduct issues, and brought a major shift in clinical research in Japan. Although the clinical research monitoring is required by the law, many investigators at Kanazawa University Hospital（KUH）hardly understand how to manage the monitoring duties by themselves. Therefore, we surveyed the current situation of understanding of the clinical research monitoring by the investigators at KUH. We sent 10 monitoring managers of 18 pieces of clinical researches conducted by KUH a questionnaire and obtained 7 number of questionnaire respondents. All the respondents were medical doctors, and 5 of them had experienced principal investigators in some other clinical researches. Furthermore, 5 of 7 respondents had experienced some clinical trials. On the other hand, all of the respondents had no experience in clinical monitoring previously. Because of that, all of them poorly understood the monitoring work and showed great concern for the accomplishment of clinical monitoring duties by themselves. These suggest that clinical research monitoring is a special skill even from clinical researchers who had experienced principal investigators. We revealed that the investigators of clinical research needed some kind of support for clinical monitoring. We have been constructing a system to support the investigators by doing the monitoring duties and holding a seminar and training periodically. By thoroughly performing notification of our system, we will continue to support even more to ensure the quality and authenticity of the clinical research.