Hiroshi Ohtsu, MS is currently the manager of clinical epidemiology and director of JCRAC data center at National Center for Global Health and Medicine, Center for Clinical Sciences. He is biostatistician and researcher of standardization of clinical research (e.g., CDISC standard, Clinical Data Management, Mythology of clinical research). He obtained Master of Science (Mathematics) in Kyushu University, Japan. After he worked Fujisawa pharmaceutical company (Astellas Pharma.), we worked as an instructor or project assistant professor at the University of Tokyo and Juntendo University. He is also a researcher at the Institute for Medical Regulatory Science, Waseda University. He has been involving numerous clinical research protocols as well as domestic and international initiatives including 'Clinical Innovation Network Japan'.