Japan User Group

Japan User Group

Yoshiteru Chiba

Head of CDISC Japan User Group

CJUG-SDTM Team Update

The monthly CJUG-SDTM meeting took place 10 May at the NTT DATA Mathematical Systems Inc. Seminar Room. We welcomed new members Habu, Toshiaki (Taiho Pharmaceutical CO.,LTD.) Mihara, Tomoko (Osaka University Hospital).

Attendees heard many informative presentations from our members including "Reconcilation between Define.XML and aCRF" “Akiba”-san presented method and purpose to reconcile between Define.XML and aCRF; "Activity Report on define.xml" “Muraoka”-san shared the experience and issue that has been accumulated through these activities with define.xml sub-team "Activity Report on Study Data Reviewer's Guide" “Matsunaga”-san shared the experience and issue that has been accumulated through these activities with Study Data Reviewer's Guide sub-team.  

The Ducks (Beginners) and Turtles (Intermediate) participated in team activities. The Ducks discussed a new sub-team division called “Simulated Clinical Trial Project”. The members of the sub-team were divided into several groups and exchanged opinions on validation software

The Turtles’ Biomedical concept sub-team discussed the patterns of CRF collection, and the patterns in DSTERM, DSDECOD, and DSCAT's "PROTOCOL MILESTONE" and "DISPOSITION EVENT" when using SDTM in DS domain. Next time, we will discuss about QS domain (combination of QSCAT and QSTEST etc.).

The Regulatory compliance sub-team’s discussions were centered on CRF design. Next time, we will discuss deliverables etc.

NTT DATA Mathematical Systems Inc. presented. "Analyzing text data using the software, text mining/data mining/deep learning." “Takashi Inaba” -san (Tsuzuki Denki Co., Ltd.) presented. "Data Analysis for the implementation of health management using Data Mining and Text Mining."

CJUG CDASH Team Update

42 members from pharmaceutical, CRO, Lab and academia comprise the CJUG CDASH team. There are currently four sub-teams who get together to discuss the following topics:

  • CRF Library with CDASH conformance
  • Investigate needs and advantage for using CDASH
  • CRF sample with CDASH conformance
  • CDASH v2.0 translation in Japanese following CDISC-COP-007

Recent Outcomes

A team member presented “A supportive document to understand CDASH:  For beginners” during the poster session at the Japan Society of Clinical Trials and Research annual meeting. This reference document is geared toward CDASH beginner implementers who want to understand the ins and outs of CDASH. The document is based on CDASH IG v2.0.