CDISC User Group in Deutschland/Japan

Hajime Shimizu (nickname: Akiba)CDISC Japan User Group

Freundschaft  Konferenzintroduction to team activity

1.CJUG/SDTM team

2.CDISC Topic in Japan

Contents

CJUG=CDISC Japan User Group

CJUG/SDTM team

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

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

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 = ?

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

CDISC topics 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

CDISC in Japan

• 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

• 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

• 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

More information

Contacthajime.shimizu@takeda.com