Translations - Chinese


Foundational Standards and Therapeutic Area User Guides

 

ADaM

 

ADaM v2.1

The Analysis Data Model (ADaM) v2.1 specifies the fundamental principles and standards to follow in the creation of analysis datasets and associated metadata. Metadata are “data about the data” or “information about the data.” ADaM supports efficient generation, replication, and review of analysis results.

分析数据模型(ADaM) 文档规定了创建分析数据集和相关元数据时要遵循的基本原则和标准。元数据是“关于数据的数据”或“关于数据的信息”。分析数据模型支持分析结果高效地生成,再现和审阅。

 

ADaMIG v1.1

ADaMIG v1.1 specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues.

ADaMIG阐述了 ADaM标准数据集结构,变量及命名规则;同时还指出了对实施过程中的问题的标准解决方案。

 

ADaM OCCDS v1.0

ADaM OCCDS v1.0: The statistical analysis data structure presented in this document describes the general data structure and content typically found in occurrence analysis. Occurrence analysis is the counting of subjects with a given record or term, and often includes a structured hierarchy of dictionary coding categories. Examples of data that fit into this structure include those used for typical analysis of Adverse Events, Concomitant Medications, and Medical History. The structure is based on the ADaM v2.1 and ADaMIG v1.1.

ADaM OCCDS v1.0: 本文中的统计分析数据结构描述了发生类数据分析中的一般性数据结构与内容。发生类数据分析用于计算有某条记录或词的受试者频数,通常包括结构化层级的词典编码归类。符合这种结构的数据示例:用于不良事件、合并用药及病史的典型分析。这种数据结构是基于ADaM模型V2.1和ADaM分析数据模型实施指南(ADaM IG)V1.1。

 

SDTMIG

 

SDTMIG v3.2

SDTMIG v3.2 is the implementation guide for Human Clinical Trials and corresponds with SDTM v1.4. SDTMIG v3.2 includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD. All previous annotations in SDTMIG 3.1.3, published in 2012, have been incorporated in SDTMIG v3.2.

SDTMIG v3.2是 SDTM v1.4用于临床试验的实施指南。SDTMIG v3.2中新增了11个域:EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, TD。2012年发布的SDTMIG 3.1.3中的注释,均已合并到了SDTMIG v3.2。


Therapeutic Area User Guide

Traditional Chinese Medicine - Coronary Artery Disease-Angina

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。


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.