Drug Evaluation Committee Principles of Monitoring Services (As it should be)
Clinical Evaluation Subcommittee
August 2016
In recent years, the clinical trial environment has been changing with the progress of computerization of clinical trials and the implementation of new methods such as risk based monitoring and remote monitoring. However, despite the changes in the environment, the essence and purpose of monitoring work is expected to remain unchanged.
The Drug Evaluation Committee's Clinical Evaluation Subcommittee's 2015 Task Force 3 examined the ideal form of monitoring work to be performed correctly so that both the monitors and the sites are not burdened by non-essential work.
This document proposes a set of Principles for monitoring as a way of thinking about how monitors should act, and presents Explanations and case studies of the Principles. Although this document is intended for monitors, their trainers and managers, we believe that it can be used not only in clinical trials, but also in investigator-initiated clinical trials and clinical research, which share the same essence.
In addition to improving understanding of monitoring, we hope that this document will help both monitors and staff at medical institutions to improve their work efficiency.