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Introduction

New Draft Japanese Translation of SDTMIG v3.2 Now Available for Public Review – Comments due 2 February 2017

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 6.3-6.4 "Findings" 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 2 February 2017.

Instructions for Reviewers

Wiki and JIRA use the same credentials, Register and/or Log in (top right) to WIKI and JIRA before starting. Download SDTMIGjp_v3.2_section6.3-6.4.docx and open in desktop application for review.

If you have no comments after review:

  1. Click 'Like' at the bottom of the page. This will help us determine who has reviewed the documents.

To add comments from within JIRA:

  1. Go to the Japanese Translation project in JIRA at: https://jira.cdisc.org/projects/JPN/issues/ (Please note, JIRA may ask you to log-in again. Your JIRA log-in is the same as your Wiki log-in)

  2. Click on the "Create" button in the top menu to bring up the Create Issue form.
  3. Choose the Japanese Translation Project.
  4. Choose the appropriate issue type - "Review Comments".
  5. Fill out the form.
    1. Provide a short summary of your comment in the "Summary" field.
    2. Choose SDTMIGjp_v3.2_section6.3-6.4 from the list in the "Component(s)" field.
    3. Enter the Line Number the comment refers to.
    4. Enter your comment, and any additional, details in the "Description". To help the team address your comment properly, be thorough.
  6. Click the "Create" button in the bottom right corner of the form to submit.

Public Review Documents 

SDTMIGjp_v3.2_section6.3-6.4.docx

 

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