Version: 
1.0
Release Date: 
2019-09-03

Version 1.0 of the Therapeutic Area User Guide for Traditional Chinese Medicine Coronary Artery Disease-Angina (TAUG-TCM-CAD-Angina) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Coronary Artery Disease-Angina and the necessary metadata to represent such data consistently with Controlled Terminology, SDTM, and ADaM.

中医冠心病心绞痛治疗领域数据标准用户指南1.0版(TAUG-TCM-CAD-Angina) 遵照CDISC标准开发程序开发,本指南描述了与冠心病心绞痛相关的最常见的生物医学概念以及呈现此类数据所需的元数据, 并且和受控术语,SDTM,ADaM标准达成统一。

Developed in partnership with CDISC volunteers, Xiyuan Hospital of China Academy of Chinese Medical Sciences, National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), and supported by the Chinese CDISC Coordinating Committee (C3C) and other TCM Institutions in China, TAUG-TCM-CAD-Angina is CDISC’s first standard to be released for Traditional Chinese Medicine as well as the first standard published in Chinese and English.

TAUG-TCM-CAD-Angina由CDISC志愿者、中国中医科学院西苑医院、美国国立癌症研究所-企业词汇服务部 (NCI-EVS)合作开发,开发过程得到了CDISC中国协调委员会(C3C)和其他中医单位的支持,TAUG-TCM-CAD-Angina是CDISC发布的首个中医治疗领域标准,也是首个以中文和英文两种语言出版的标准。

TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.

TA标准将基础标准扩展到呈现与疾病领域内特定适应症相关的数据。CDISC标准详细说明如何模型和呈现数据; 但并没有规定应该收集哪些数据,也没有规定如何进行临床试验、试验的评估或终点。

Public Review Comments

公众审评意见

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.

CDISC发布公众审评意见和决议,以确保透明度,并向实施者展示在标准开发过程中如何处理意见。

TA Specifications

TA 说明

TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2

TA说明展示了如何为SDTM和SDTMIG的不同版本修改TAUG示例。这些说明帮助FDA和日本PMDA进行测试,以支持这些标准并将其包含在各自的技术一致性指南中.1, 2

The specifications comprise five worksheets in an Excel workbook:

TA说明由1个Excel工作簿中5个工作表组成。

  • Read Me – Information on how to read the other worksheets
  • 阅读说明–关于如何阅读其他工作表的信息
  • Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  • 摘要- TAUG的目录,附有示例和示例使用的域和变量
  • Known Issues – A list of modeling issues noted in the TAUG
  • 已知问题–TAUG中列出的建模问题列表
  • Domains – Domains used and their status in different versions of the SDTMIG
  • 域–SDTMIG不同版本中使用的域及其状态
  • Variables – Variables used and their status in different versions of the SDTM
  • 变量–SDTM不同版本中使用的变量及其状态
  1. http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
  2. https://www.pmda.go.jp/files/000206449.pdf