The J3C supports global CDISC initiatives in Japan and provides regional feedback to the central CDISC organization. The committee's primary activities are defined in collaboration with CDISC Executive Operations and include:
- Introducing CDISC and broadening its presence in Japan
- Acting as a liaison between CDISC and Japanese entities
- Helping the CDISC organization to acquire collaborations and partnership with existing Japanese organizations
- Organizing and planning for annual CDISC Japanese conferences and events
For more information on the CDISC Coordinating Committees, please see the CDISC Coordinating Committees Charter.
Draft Japanese Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 Available for Public Review - Comments due 02 February 2018
The Nagoya Medical Center, Translational Research Informatics Center (TRI) and CDISC Japan User Group (CJUG) SDTM Team have worked collaboratively to translate the Study Data Tabulation Model Implementation Guide version 3.2 (SDTMIG v3.2) into Japanese.
Today, the Japan CDISC Coordinating Committee (J3C) is pleased to announce that the draft translation of the “fourth batch” (content from Section 6.3 "Findings" through Section 6.4 "Findings About Events or Interventions" of SDTMIG v3.2) is now available for public comment. Public review for this particular standard will be completed in small batches rather than for the whole document at once, while taking into consideration the document as a whole. Public review for the following batches is anticipated to take place every 5 weeks going forward, until the entire translation has been reviewed.
Please note, this review is to assess the quality of the translation of SDTMIG v3.2 into Japanese. This is not a review of SDTMIG v3.2, which can be found here.
CDISC and the J3C encourage those using this standard in Japan to participate in this public review in order to contribute to the improvement and quality of the translation. The 35-day public review period for the second batch of the Japanese translation of SDTMIG v3.2 will end on 24 November 2017.
CDISC and the J3C held a public webinar on 15 September 2017 to present the collaborative work of The Nagoya Medical Center, Translational Research Informatics Center (TRI) and CDISC Japan User Group (CJUG) SDTM Team who translated the SDTMIG v3.2 into Japanese. They also demonstrated and explained the public review process, including the use of JIRA to provide comments on the translation. Please view a recording of the public webinar here.