Application of electronic data capture system to a clinical study in Japan

Abstract

The major factors that have heretofore prevented an efficient implementation of clinical trials include deviations from the protocol at the investigator's site, defectiveness in filling out the case report forms (CRFs), frequent monitoring and fixing work of patient data by the sponsor, handwritten preparation of various documents, and so on. As an experiment in electronic implementation of an efficient clinical trial utilizing information technology, we formed an electronic data capture (EDC) system that efficiently collects clinical data from the investigator's site, and applied it to a clinical trial. As a result, there was no patient with a GCP violation and thus all were eligible as study subjects and the number of correction log form (CLF) for CRFs was considerably reduced. In addition, it was possible to conduct an efficient clinical trial and shorten the study period by utilizing this EDC system. We discuss the future readiness for clinical trials based on this experience of implementation, as well as the challenges that lie ahead.