CDISC Foundational Standards (CDASH, SDTM, ADaM) in Chinese version

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收藏 2013-07-19

前同事们协调官方授权编译的CDISC standard，版上还是有不少从事clinical trial领域的同学的，所以分享一下。
http://www.cdisc.org/may-2013-newsletter#foundational
[url=]CDISC Foundational Standards (CDASH, SDTM, ADaM) in Chinese version are released for public review[/url]
The China CDISC Coordinating Committee (C3C) and CDISC Standards Translation and Review (C-STAR) project team are pleased to announce the release of CDASH (v1.1), SDTM (SDTM v1.2 /SDTMIG v3.1.2) and ADaM (ADaM 2.1 /ADaMIG 1.0) for public review after 2 years of effort. (See below for the Chinese version of this announcement).

C-STAR was setup in May 2011 to review the Chinese translation of CDISC Foundational Standards which were provided by Absolute Systems Clinical Data Co., Ltd. All participants are volunteers from CRO, pharmaceutical companies and academia who are CDISC standard experts or practitioners experienced in this area. In order to ensure the highest quality of the translation and the adherence to the original English version, a very strict translation process was developed: translation, editing, proofreading, review and then cross review.

CDISC Foundational Standards provide the basis for the complete CDISC suite of standards, supporting the clinical research process from protocol through data collection, data management, data analysis and reporting. The Clinical Data Acquisition Standards Harmonization (CDASH) Standard defines basic standards for the collection of clinical trial data. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). The SDTMIG should be used in close concert with the current version of the CDISC Study Data Tabulation Model (SDTM) that describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities. The ADaM document explains the purpose of the Analysis Data Model. It describes fundamental principles that apply to all analysis datasets, with the driving principle being that the design of analysis datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of submitted analysis datasets. The Analysis Data Model supports efficient generation, replication, and review of analysis results.

The translation of CDISC standards is expected to greatly increase CDISC awareness in China clinical research industry, including academia and regulatory agencies. In addition, C3C and C-STAR are making every effort to introduce and facilitate CDISC standards into practice in China, so China can gradually improve the data quality of clinical trials and play a more important role in the global clinical research environment.

Please note that comments are being requested on the translation into Chinese, NOT on the standards themselves.

CDISC基础标准（CDASH，SDTM和ADaM）中文版发布征集意见稿中国CDISC协调委员会（C3C）与CDISC标准翻译审阅（C-STAR）项目组很高兴宣布：经过两年的努力，CDASH （v1.1），SDTM（SDTM v1.2/SDTMIG v3.1.2）和 ADaM （ADaM v2.1 /ADaMIG v1.0)中文版征集意见稿发布了。 C-STAR成立于2011年5月，以审阅CDISC基础标准（CDISC Foundational Standards）的中文翻译初稿。这些初稿由北京阿贝斯努信息技术有限公司（Absolute Clinical Data Systems Co., Ltd）提供。所有参与的志愿者均来自CRO、制药企业或学术界中的CDISC标准的专家及在该领域有丰富经验的从业者。为了确保最高的翻译质量，并忠于英文原版，C-STAR项目组制定了一套非常严格的翻译流程：翻译，编辑，校对，审阅，然后交叉审阅。 CDISC基础标准（CDISC Foundational Standards）提供了CDISC全部配套标准的基础，支持临床试验的全过程：从方案设计到数据采集、数据管理、数据分析及报告生成。临床数据获取标准（CDASH）定义了临床数据采集的基本标准。临床试验中研究数据列表模型实施指南（SDTMIG）意在指导递交给监管机构，如美国食品药品管理局（FDA）的标准临床试验列表数据集的组织、结构及格式。在使用SDTMIG时应紧密参照当前版本的CDISC研究数据列表模型（SDTM），该模型描述了用于递交给监管机构的临床研究数据所需应用的通用概念模型。分析数据模型（ADaM）文档解释了分析数据模型的目的，描述了适用于所有分析数据集的基本原则。其驱动原则是，分析数据集与其关联的元数据的设计，能够促进对递交的分析数据集的内容、来源、和目的的清晰理解。利用ADaM可以高效地生成、再现、审阅分析结果。 CDISC标准的中文版的翻译将能在中国临床研究领域，包括在学术界和监管机构，扩大CDISC的知晓度。另外，C3C和C-STAR将不遗余力地介绍和促进CDISC标准在中国的应用，以使中国可以逐渐改善临床试验数据的质量，并在全球临床研究领域扮演更重要的角色。请于2013年7月16日之前，将您的建议使用如下CDISC收集建议模板发回给我们。

Click here to view the standards for review.

Please send your comments by 16 July 2013 using the CDISC comment templates below:

Please send your comments on these Chinese versions of CDISC standards to CDISCChina@cdisc.org.