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CDASH Model v1.0 CDASH 模型 v1.0

Clinical Data Acquisition Standards Harmonization Model
临床数据采集标准协调模型

Version 1.0 版本 1.0

Notes to Readers 读者须知

This is Version 1.0 of the Clinical Data Acquisition Standards Harmonization Model.
这是临床数据采集标准协调模型的版本 1.0。

Revision History 修订历史

Date 日期Version 版本
2017-09-201.0 Final 1.0 最终版

© 2017 Clinical Data Interchange Standards Consortium. All rights reserved. See also Representations and Warranties, Limitations of Liability, and Disclaimers.
© 2017 临床数据交换标准联盟。保留所有权利。另请参见陈述和保证、责任限制及免责声明。

1 Introduction 1 引言

The Clinical Data Acquisition Standards Harmonization (CDASH) Model describes the foundational structure for the organization, naming, and description of variable and associated attributes to support data collection in clinical trials. The CDASH Model provides naming conventions for the CDASH Implementation Guide (CDASHIG) variables along with additional metadata to help facilitate mapping collected data to their respective SDTM Implementation Guide (SDTMIG) variables.
临床数据采集标准协调(CDASH)模型描述了组织、命名和描述变量及其相关属性的基础结构,以支持临床试验中的数据收集。CDASH 模型为 CDASH 实施指南(CDASHIG)变量提供了命名约定,并附加了元数据,以帮助将收集的数据映射到相应的 SDTM 实施指南(SDTMIG)变量。

The CDASH Model aligns with and is structured similarly to the SDTM Model. The CDASH Model organizes data into classes, which represent meaningful groupings of data in clinical research. It defines CDASH metadata for identifier variables, timing variables, general observation class variables (Events, Interventions, and Findings), domain-specific variables, and special-purpose domain variables, (e.g., DM, CO).
CDASH 模型与 SDTM 模型一致,并且结构相似。CDASH 模型将数据组织成类别,这些类别代表临床研究中有意义的数据分组。它定义了 CDASH 元数据,包括标识符变量、时间变量、一般观察类别变量(事件、干预和发现)、特定领域变量以及特殊用途领域变量(例如,DM、CO)。

Sponsors may implement any CDASH variable defined by a Class within one of its respective CDASHIG domains. Any variable found in a data class in the CDASH Model may be implemented in any CDASHIG domain within that class. For example, the Interventions class variable --ROUTE, although not defined in the Substance Use (SU) domain, may be added to SU if needed. The domain-specific section of the CDASH Model defines variables that may not be reused across multiple Domains for a given Class.
赞助商可以在其各自的 CDASHIG 领域内实施由某个类别定义的任何 CDASH 变量。CDASH 模型中数据类中的任何变量都可以在该类的任何 CDASHIG 领域中实施。例如,干预类变量 -- ROUTE,尽管未在物质使用 (SU) 领域中定义,但如果需要,可以添加到 SU 中。CDASH 模型的领域特定部分定义了在给定类别中可能无法在多个领域之间重用的变量。

Similar to the SDTM Model and SDTMIG, not all CDASH Model variables are replicated in each CDASHIG domain. Commonly used CDASH Model variables are included within their respective CDASHIG Domains.
与 SDTM 模型和 SDTMIG 类似,并非所有 CDASH 模型变量都在每个 CDASHIG 领域中复制。常用的 CDASH 模型变量包含在各自的 CDASHIG 领域中。

Attributes defined for each Model variable are: Class, Name, Label, Question Text, Prompt, Data Type, SDTM Target, SDTM Mapping Instructions, Definition, Controlled Terminology Codelist Name, and Implementation Notes.
每个模型变量定义的属性包括:类别、名称、标签、问题文本、提示、数据类型、SDTM 目标、SDTM 映射说明、定义、受控术语代码列表名称和实施说明。

Reference the CDASHIG for more information about using this Model to implement each of the domain classes (including Findings About) and creating custom domains.
参考 CDASHIG 以获取有关使用此模型实现每个领域类(包括发现相关)和创建自定义领域的更多信息。

2 The CDASH Model 2 CDASH 模型

2.1 Interventions 2.1 干预措施

Interventions 干预措施

2.2 Events 2.2 事件

Events 事件