Draft Japanese Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 Available for Public Review
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.
The Japan CDISC Coordinating Committee (J3C) is pleased to announce that the draft translation of the “fifth batch” (content from Section 6.3 of SDTMIG v3.2) is now available for public comment. Public review for this particular standard is being 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 fiver 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 Japanese to participate in this public review 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 9 March 2018.
To view the user guide: Draft Japanese SDTMIG v3.2 section6.3
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SDTM v1.4 と ADaMIG v1.0 が日本語に翻訳されました。CDISC は翻訳を行ってくださった名古屋医療センター、日本のCDISCユー ザーグループ (CJUG)および先端医療振興財団 臨床研究情報センター (TRI) に大変感謝しております。これらの文書はCOP-007に 順守して作成されました。
CDISC is pleased to announce SDTM 1.4 and ADaMIG 1.0 have been translated to Japanese. We are very grateful to the Nagoya Medical Center, CDISC Japanese User Group (CJUG), and Translational Research Informatics Center (TRI) for their assistance in providing the translations. These documents were created in compliance with COP-007.