薬理と治療

Abstract

Objectives We propose a concrete model of IT using central monitoring system, to optimize the process of clinical trial. Methods We assessed every process of current monitoring practices and discriminated the process which can be conducted by Off Site monitoring. Furthermore, we researched more efficient monitoring practices by consolidated information and use of IT system. Result We proposed the Project Portal Site for the institutions, sponsors, CROs and SMOs to share and exchange all study related information. Sponsor’s Operation Center manages the Project Portal Site and conducts the Off Site monitoring. We listed the functions of Project Portal Site and tasks of Operation Center. We estimated that this model is able to reduce the monitoring practices more than 40%compare to the ordinary practice. Conclusion The proposed IT based central monitoring system might be able to contribute to improve the quality in terms of information sharing and consolidation by drastic reduction of monitoring related number of man-hour.