1. 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

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

3. CJUG/SDTM team

4. 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

5. 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

6. 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 = ?

7. 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

8. CDISC topics in Japan

9. CDISC in Japan
PMDA requires e-data submission in CDISC format near future.
Authority released several documents.
Basic Principles on Electronic Submission
Notification on Practical Operations
Technical Conformance Guide
Data Standards Catalog

10. 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 Apr 2020
Transition period CDISC

11. 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

12. More information Plan of CDISC pilot 2015 (PMDA)
Report of CDISC pilot nd-half (PMDA)
Coming soon
Report of CDISC pilot st-half (PMDA)
Report of CDISC pilot 2013 (PMDA)

13. Contact