RESEARCH ARTICLE a i To

Full list of author information is available at the end of the articledrugs and medical devices (designated “registration trials” in the present article). The Japanese infrastructure for registration trials has improved since the introduction of the Good Clinical Practice (GCP) standard in 1997 and plans for the promotion of registration trials by the is now widely recognized not only for practical pursuit, but also for quality assurance in these trials. On the other hand, investigator-initiated health research is conducted based on Japanese governmental guidelines