Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Published Date:

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 collecting and representing the data using CDASH and  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)


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。

Public Review Comments


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。