2015 年 46 巻 4 号 p. 211-224
Ethical Guidelines for Medical Research Involving Human Subjects have been enforced since April 2015 by the Ministry of Health, Labour and Welfare and the Ministry of Education, Science and Technology. According to the guidelines, a research project categorized as interventional or invasive clinical study that starts from October 2015 or later should implement monitoring and if necessary audit. Several study groups have issued guidelines on monitoring and audit, which seem to be appropriate for large-scale drug clinical trials, but a quality assurance system for other kinds of research is needed, especially for exploratory clinical research. We developed a scheme for exploratory clinical research, which we have been using even before monitoring and audit become mandatory. This scheme is composed of: (1) a questionnaire-based check sheet; (2) letter for site visit; (3) site visit protocol; and (4) site visit check sheet. We found that the scheme which we have implemented is useful for human subject protection and quality assurance of clinical research. This scheme can be applied flexibly according to the type and characteristics of other research projects.