cdisc user group in deutschland/japan hajime shimizu (nickname: akiba) cdisc japan user group...
TRANSCRIPT
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