Abstract
Development of computer and information-communication technology has brought significant changes to clinical trials. The Action Plan for the 5-Year Clinical Trials Vitalization Plan 2012 set the target of “utilizing information technology further” and aims to have the Institutional Review Boards prepare review materials in electronic form for clinical trial procedures. Digitalization can simultaneously improve both the efficiency and quality of operations. However, it has some disadvantages, such as data corruption that instantly causes loss of visual readability and difficulty in detecting falsifications. This paper explains the points to be considered for correct digitalization of clinical trial procedures, including clarification of legal issues.
