薬理と治療

Abstract

The Ethical Guidelines for Clinical Research mandate the monitoring of invasive intervention studies to secure the reliability. Monitoring is also mandatory for specified clinical trials in Clinical Trials Act. In academia, establishing a monitoring system that can be implemented with limited resources is essential. In this study, we present a feasible monitoring system that will secure a certain level of quality while being implemented in an investigator‒initiated clinical trial（corresponding to a multicenter, double‒blind, comparative, and specified clinical trial）. This monitoring system is implemented through a combination of several factors such as: developing a monitoring plan that considers the research implementation system of the institution, creating monitoring work support tools, providing practical monitoring education for personnel who already belong to research institutions, and outsourcing some operations to the Clinical Research Organization（CRO）. In this way, a monitoring system that can be implemented even with limited resources, can be developed.