Freundschaft Konferenz

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Presentation transcript:

Freundschaft Konferenz 2018/11/15 CDISC User Group in Deutschland/Japan Freundschaft Konferenz introduction to team activity Hajime Shimizu (nickname: Akiba) CDISC Japan User Group

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

CJUG/SDTM team

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

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

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

What we've learnt 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. SDRG=Study Data Reviewers Guide

CDISC topics in Japan

CDISC in Japan 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

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

Japan specific features 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

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

Contact hajime.shimizu@takeda.com