*Mihoko Okada¹, Chris Decker², Rhonda Facile², Yuki Ando³, Naoichi Sato⁴, Naoki Nakashima⁵, Daisuke Koide⁶, Satoshi Ueno⁷ (1. Institute of Health Data Infrastructure for All, 2. Clinical Data Interchange Standards Consortium (CDISC), 3. Pharmaceuticals and Medical Devices Agency, 4. Medical Information Center, Kyushu University Hospital, 5. Department of Medical Informatics, Graduate School of Medical Sciences, Kyushu university, 6. Department of Biostatistics & Bioinformatics, Graduate School of Medicine, The University of Tokyo, 7. Center for Health Informatics Policy, National Institute of Public Health)

*Chris Decker¹ (1. Clinical Data Interchange Standards Consortium (CDISC))

*Rhonda Facile¹ (1. Clinical Data Interchange Standards Consortium (CDISC))

*Yuki Ando¹ (1. Pharmaceuticals and Medical Devices Agency)

*Naoichi Sato¹, Naoki Nakashima² (1. Kyushu University Hospital Medical Information Center, 2. Medical informatics, Graduate School of Medical Sciences, Kyushu University)

*Daisuke Koide¹ (1. Dept.of Biostatistics & Bioinformatics, Grad. of Med, The Univ. of Tokyo)

*Satoshi Ueno¹ (1. National Institute of Public Health)