1. CDISC User Group in Deutschland/Japan Hajime Shimizu (nickname: Akiba) CDISC Japan User Group introduction to team activity

2. 1.CJUG/SDTM team 2.CDISC Topic in Japan Contents CJUG=CDISC Japan User Group

4. Our members 140+ people Pharma, CRO, IT, Academia Data Manager, Statistician, Programmer etc. Our activities Monthly Meeting Guest speaker Group tasks Socializing event CJUG/SDTM team Deutschland Japan in next slide

5. Group Tasks Read/Learn SDTM incl. Translation SDTM relevant topics 1.WHO DD 2.File size issue 3.What's dataset-XML? 4.Therapeutic Area 5.SDTM by R (free statistical software)etc. Virtual SDTM creation Legacy Data Conversion All domains Protocol  ADaM Global study CJUG/SDTM team in next slide

6. Imaginary protocol Generate data Make it into SDTM We learn more about SDTM Virtual SDTM creation Caffeine enhances concentration. More calculation can be done. (2+9) mod 10 = ? (9+5) mod 10 = ? (5+1) mod 10 = ?

7. CRF should be in CDISC compliant. Check data by OpenCDISC in early phase. Define.XML requires a lot of information. SDRG template is good. ADaM is so flexible than SDTM. What we've learnt SDRG=Study Data Reviewers Guide

9. PMDA requires e-data submission in CDISC format near future. Authority released several documents. Basic Principles on Electronic Submission http://www.pmda.go.jp/files/000160019.pdf Notification on Practical Operations http://www.pmda.go.jp/files/000206451.pdf Technical Conformance Guide http://www.pmda.go.jp/files/000206449.pdf Data Standards Catalog http://www.pmda.go.jp/files/000206482.zip CDISC in Japan

10. From Oct 2016, PMDA receives e-data submissions in CDISC. After Apr 2020, e-data submission is mandatory. When it starts? Oct 2016 Apr 2020 Transition period CDISC

11. All trials in a submission must be in CDISC format. Legacy data conversion Japanese texts are submitted in separate datasets. comments, reported terms Drugs should be coded in WHO DD. FDA includes WHO DD in catalog. PMDA states it in guideline SI Unit --STRESU Japan specific features

12. Plan of CDISC pilot 2015 (PMDA) http://www.pmda.go.jp/files/000161446.pdf Report of CDISC pilot 2014 2 nd -half (PMDA) Coming soon Report of CDISC pilot 2014 1 st -half (PMDA) http://www.pmda.go.jp/files/000160439.pdf Report of CDISC pilot 2013 (PMDA) http://www.pmda.go.jp/files/000160068.pdf More information

13. hajime.shimizu@takeda.com