Friday, 05 November; 13:00pm – 17:30pm Japan Standard Time
This half-day workshop will feature presentations on how CDISC can be utilized by academia in Japan. New initiatives like the CDISC Academic Start Pack and CDISC Open Source Alliance (COSA) will be discussed. Researchers will share the challenges, value, use cases and review processes of using CDISC standards.
Please note: this workshop will be held in Japanese.
Academic-focused presentations by thought leaders from...
- National Hospital Organization (NHO) Nagoya Medical Center
- University Hospital Medical Information Network (UMIN) Center
- Sapporo Medical University
- Tohoku University Graduate School of Medicine
- Kanazawa University
| 13:00-13:05 | Opening Remarks | Akira Soma, J3C Chair, Japan Oracle |
| 13:05-13:30 | CDISC Open Source Alliance (COSA) | Dr. Sam Hume, VP, Data Science, CDISC |
| 13:30-13:55 | CDISC Academic Start Pack | Rhonda Facile, VP, Development Opportunities & Partnerships, CDISC |
| 13:55-14:25 | AMED Project - Research on Inter-Institutional Collaboration for Promoting the Use of CDISC Standards in Academia | Dr. Toshiki Saito, Director, Department of Regenerative Medicine, Clinical Research Center, National Hospital Organization Nagoya Medical Center |
| 14:25-14:45 | Challenges with Promoting the Use of CDISC Standards in Academic Organizations - Case of Clinical Research Data Center at Tohoku University Hospital | Dr. Takuhiro Yamaguchi, Professor at Division of Biostatistics, Tohoku University Graduate School of Medicine and Director of Clinical Research Data Center, Tohoku University Hospital |
| 14:45-15:05 | A Case of Data Management in Conformity with CDISC/SDTM in Academia - Kanazawa University | Dr. Shizuko Takahara, Assistant Professor, Innovative Clinical Research Center, Kanazawa University |
| 15:05-15:25 | Break | -- |
| 15:25-15:45 | Some TIPS for Collaboration with Academia Based on an Experience of Assessing Convertability of ISS Study Data to CDISC-compliant Data Format | Yumiko Kawabata, Biostatistics Group2, Biostatistics & Programming, Clinical Science and Operation, R&D, Sanofi KK |
| 15:45-16:05 | CRO Support for Investigator-Initiated Clinical Trials | Takahiro Tano, Japan CRO Association |
| 16:05-16:25 | CDISC Education in Japan | Yoshiteru Chiba, UMIN Center |
| 16:25-16:45 | Tips for Obtaining Useful Information to Aid in Implementing CDISC Standards | Naoto Yazaki, CDISC Task Force, Data Science Expert Committee, Japan Pharmaceutcal Manufactuers Association |
| 16:45-17:05 | Public Tools Available for Use with CDISC Standards | Kunihito Ebi, Fujitsu Limited |
| 17:05-17:10 | Closing Remarks | Dr. Takahiro Kuchi, Director, UMIN Center, the University of Tokyo Hospital Professor, Department of Health Communication |