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SDTM v1.4日本語版(案)パブリックレビュー



SDTM v1.4日本語版(案)


Japan CDISC Coordinating Committee


現在、独立行政法人 国立病院機構 名古屋医療センター様および公益財団法人 先端医療振興財団 臨床研究情報センター様が共同して、SDTM v1.4およびSDTM IG v3.2日本語版(案)を作成されております。本翻訳はCDISCの翻訳手順書である「COP 007 - CDISC Translations」のプロセスに従って作成されており、品質管理の一環としてCDISC Japan User Group SDTMチームの有志による独立レヴューも行われております。


今般、SDTM v1.4についてCOP 007に従ったパブリックレヴューの準備が整いましたのでご連絡申し上げます。パブリックレヴューの目的は、適切な翻訳物となるようにより広い範囲の利用者の方からご意見を伺い、適宜成果物に反映させることです。





SDTM v1.4





※コメント提出方法については文末の【別紙】「How to use the CDISC Public Comment Tracker」をご参照ください。







  • 日本語訳ではなく原文のCDISC標準そのものに関する質問または修正の提案
  • 本翻訳物の作成に際して日本語化の対象としていない個所(例、ドメインモデル例示テーブル中のテキスト)に対する翻訳の要望
  • 原文の正しい解釈に影響を与えないような代替表現の提案(個人の好みに属すると思われる同義の異なる日本語表現の提案を含む)
  • 変更を要望する個所や具体的な変更内容が特定されていない意見(例、「よりわかりやすい日本語の提示をお願いしたい」等)




How to use the CDISC Public Comment Tracker


For Comment Authors



Welcome to the CDISC Public Comment tracker guide for Comment Authors. This document is to assist with entering issues into the Comment tracker and explain the fields available and what can be entered into each. This guide assumes that you already have a copy of the document being reviewed. The public comment tracker is located at 

  1. When you go to you should have the option to sign in or register. If you have ever registered for a document review or are a member of a CDISC team, you should already have a login and be able to sign in. If you do not have a login or are not sure, use the Register link to create a new account. If you have any questions or issues with signing in, please contact
  2. If you have no comments, please record that you have reviewed the document:
    1. Go to the “COMMENTS” section (left menu).
    2. Click on the “LIST TOOLS” tab in the ribbon at top and then choose “ITEMS”, and then “New Item” in the ribbon.
    3.  Type “OK” in the comment title.
    4. Choose the documents in the drop down for “Document Being Commented On
    5. Check the box, “Reviewed – No Comments

                f. Save the comment.

     3. To provide detailed feedback, click on COMMENTS section (left menu). If there are other document comments listed, you can filter your view by clicking the arrow to the right of “Document Being Comment On” header and choose your document from the drop down list. This should display all recent comments by all authors for the document you are reviewing, and allow you to see if your issue has already been submitted by someone else. If you do not see your issue mentioned in other comments, create a new comment.

     4. To create a new comment:

                a. At top select the “LIST TOOLS” tab and then select ITEMS.

                b. Select NEW ITEM on the left, in the ribbon at top to create a new comment.

     5. Here is the list of fields and descriptions:

      1. Comment Title – A brief description of the issue.
      2. Document Being Commented On – this a drop down menu of all documents in review. Choose the document you are currently reviewing.
      3. Document Section – This can include items such as page, section, subsection, or line number.
      4. Reviewed– No Comments – This is checked when the document has been reviewed and no changes are suggested. You can simply enter OK in the Comment Title and click save if this is checked.
      5. Comment – This is a free text field that allows you describe the issue in detail.
      6. Comment Author – An auto-populated field with the comment author’s login.
      7. Comment Category – General categories to help group comments:

                                     i.         Typo - Use this category if there is a misspelling or other typographical error.

                                     ii.         Question - Do not use this category for review of this document.

                                     iii.         Major Issue - Use this category if the translation is incorrect or should cause misunderstanding and must be resolved before the final publication of the standard.

                                     iv.         Minor Issue - Use this category if the translation should be replaced with more stable description or wording to avoid possible misunderstanding.

                                     v.         Suggestion - Use this category if the comment is a recommendation to the team.

     6. Click Save to submit the comment.



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