1. Japanese Society for Medical and Biological Engineering:Guidelines to decide the applicability to Clical Trials Act. <http://jsmbe.org/rinkenhou-guideline.html> [accessed January 9, 2021]. (in Japanese)
3. Ministry of Health Labour and Welfare:Medical Practitioners’Act, No. 201.<https://www.mhlw.go.jp/web/t_doc?dataId=80001000> [accessed January 9, 2021]. (in Japanese)