Most Commonly Used Controlled Terminology
常用受控术语
The Chinese CDISC Coordinating Committee (C3C) discussed and selected the most used Controlled Terms for Chinese translations. Volunteers from the Controlled Terminology group translated this list of Controlled Terms into Chinese following the agreed translation process (cross review by volunteers and final round review by team lead). This list of translated Controlled Terms as published on CDISC website for Public Review for one month. The C3C went through the comments and refined the translation again.
C3C讨论后挑选了最常用的受控术语做了中文翻译。CT组志愿者，按照既定翻译流程（志愿者先内部交叉审阅，组长做最终审阅），将此受控术语列表翻译成中文。然后上传中文受控术语到CDISC官网，开放公众审阅一个月。C3C整理收集到的公众审阅意见后，重新做必要的调整并定稿发布。
Most Commonly Used Controlled Terminology - Chinese Translation 常用受控术语
Foundational Standards
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 Guides
Traditional Chinese Medicine - Acupuncture
Version 1.0 of the Therapeutic Area User Guide for Traditional Chinese Medicine Acupuncture (TAUG-TCM-Acupuncture) was developed under the CDISC Standards Development Process. The purpose of this User Guide is to describe how to use CDISC standards to represent data pertaining to traditional (manual) acupuncture studies. Version 1.0 primarily focuses on “common” acupuncture device-related concepts, such as acupuncture study design elements, acupuncture device information, device (treatment) exposure, device events, and common adverse events collected that are related to acupuncture administration and needle events. The User Guide provides advice and examples for representing the data using SDTM.
The TAUG was developed by volunteers from the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) and Chinese CDISC Coordinating Committee (C3C).
TAUGs 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.
中医针刺治疗领域标准用户指南 (版本1.0)
发表日期：2023年6月6日
中医针刺治疗领域标准用户指南 (版本1.0) 的开发严格遵循了 “CDISC 标准开发流程”。本指南的目的是描述如何使用 CDISC 标准来展示与传统针灸 (手工刺入式) 研究相关的数据。版本1.0主要关注常见的针刺设备相关的概念, 比如针刺研究设计元素、针刺设备信息、设备 (干预措施) 暴露、设备类事件以及常见的与针刺治疗或针灸针事件相关的不良事件，并提供使用临床数据采集标准 (CDASH) 和研究数据制表模型 (SDTM) 来收集和展示数据的实例。
本用户指南由来自广州中医药大学第二附属医院 (广东省中医院), 美国国家卫生研究院 - 美国国家癌症研究所 - 企业词汇服务部 (NIH NCI-EVS), CDISC 中国协调委员会 (C3C) 的志愿者支持和开发。
TAUGs 扩展了基础标准以表示与疾病领域内特定适应症相关的数据。 CDISC 标准详细说明了如何构建数据；但并不规定应收集哪些数据，也不规定应如何开展临床试验、进行评估或终点评价。
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.