Translations - Japanese

Standards

 

CDASH Model v1.0 and CDASH Implementation Guide v2.0

CDASHIG v2.0とCDASH Model V1.0が日本語訳されました。CDASHIG v2.0、CDASH Model V1.0、およびCDASHIG メタデータテーブルでは、臨床試験データを収集するための基本的な基準に加え、具体的なCase Report Form(CRF:症例報告書)の標準を実装する方法を規定しています。CDISC は翻訳を行ってくださった国立がん研究センター東病院、医療イノベーション推進センター (TRI)、および日本のCDISCユー ザーグループ (CJUG)およびに大変感謝しております。この文書はCOP-007に 順守して作成されました。

CDISC is pleased to announce the CDASHIG v2.0 and the CDASH Model v1.0 have been translated in Japanese. CDASHIG v2.0, the CDASH Model v1.0, and CDASHIG metadata tables define standards for the collection of clinical trial data and how to implement the standard for specific case report forms. We are very grateful to the National Cancer Center Hospital East, the Translational Research Center for Medical Innovation, and the CDISC Japanese User Group (CJUG) for their assistance in providing the translations. These documents were created in compliance with COP-007.

Downloads:

CDASH Model v1.0

CDASHIG v2.0


SDTMIG v3.2, SDTM v1.4, ADaMIG v1.0

CDISC is pleased to announce SDTMIG v3.2, SDTM v1.4 and ADaMIG v1.0 have been translated to Japanese. We are very grateful to the National Hospital Organization 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.

SDTMIG v3.2 と 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国立病院機構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。

Downloads:

PDF iconSDTMIG v3.2_JPN_v1.0.pdf

PDF icon SDTM v1.4_JPN_v1.0.pdf

PDF icon ADaMIG v1.0_JPN_v1.0.pdf


Summary Documents

Hajimete-no-ADaM (ADaM Summary Document)

In close collaboration with the CDISC ADaM team, the CDISC Japan User Group (CJUG) ADaM team has prepared a summary document of ADaM v2.1 in Japanese. The team’s intention is to publish a concise and user-friendly document geared toward users new to ADaM. The CJUG ADaM Team followed COP 007 to ensure the quality of the content of this document.

はじめての ADaM Summary Document


Translation Discrepancy Disclaimer

Should any discrepancy between the original CDISC documentation and its translation be recognized, the original CDISC documentation shall prevail. In light of this, the translated version of a standard or related documentation will include a disclaimer noting to use the original version of the document for any clarification.