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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

2.3 Findings 2.3 发现

Findings 发现

2.4 Identifiers 2.4 标识符

Identifiers 标识符

2.5 Timing 2.5 时间安排

Timing 时机

2.6 Special Purpose 2.6 特殊目的

Special Purpose 特殊目的

2.7 Domain-Specific 2.7 领域特定

Domain-Specific  领域特定

Appendices 附录

Appendix A: Representations and Warranties, Limitations of Liability, and Disclaimers
附录 A:陈述与保证、责任限制和免责声明

CDISC Patent Disclaimers CDISC 专利免责声明

It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention.
实施和遵守本标准可能需要使用受专利权保护的主题。发布本标准并不表明对与之相关的任何权利要求或专利权的存在或有效性持有任何立场。CDISC,包括 CDISC 董事会,不对识别实施本标准可能需要许可的专利权利要求负责,也不对其注意到的专利或专利权利要求的法律有效性或范围进行调查。

Representations and Warranties
陈述和保证

"CDISC grants open public use of this User Guide (or Final Standards) under CDISC's copyright."
CDISC 授予公众开放使用本用户指南(或最终标准)的权利,受 CDISC 版权保护。

Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant's ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy ("the Policy")); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants.
每个参与制定本标准的参与者在其贡献(或其代表)时应被视为声明、保证和承诺,尽其所知和能力:(a)其拥有或有权授予在其拥有相关知识产权的所有司法管辖区或地区对其所有贡献的相关许可;(b)参与者在此所作的授予、确认和协议没有限制;以及(c)该贡献不使任何贡献、草案标准、最终标准或其实施的全部或部分,受到与本政策中规定的许可义务不一致的额外限制或要求,或要求任何此类贡献、最终标准或实施的全部或部分:(i)以源代码形式披露或分发;(ii)为制作衍生作品而许可(除非如 CDISC 知识产权政策(“政策”)第 4.2 节所述);或(iii)免费分发,除非如第 3、5.1 和 4 节所述。政策第 2 条。如果参与者知道任何参与者或其他方所作的贡献可能使任何贡献、草案标准、最终标准或实施的全部或部分受到第 9.3 节中列出的一个或多个许可义务的约束,该参与者应及时通知 CDISC 主席,主席应及时通知所有参与者。

No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT STANDARDS, ARE PROVIDED "AS IS" WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL, FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION.
没有其他担保/免责声明。所有参与者承认,除非根据 CDISC 知识产权政策第 9.3 节的规定,所有草案标准和最终标准,以及对最终标准和草案标准的所有贡献,均按“原样”提供,且不提供任何形式的担保,无论是明示、暗示、法定或其他,参与者、代表、CDISC 总裁、CDISC 董事会及 CDISC 明确否认任何关于适销性、非侵权、特定或预期用途的适用性或任何其他因任何提案、最终标准或草案标准或贡献而产生的担保。

Limitation of Liability 责任限制

IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
在任何情况下,CDISC 或其任何组成部分(包括但不限于 CDISC 董事会、CDISC 总裁、CDISC 员工和 CDISC 成员)对任何其他个人或实体不承担因本政策或任何相关协议而产生的利润损失、使用损失、直接、间接、附带、后果性或特殊损害的责任,无论是基于合同、侵权、担保或其他原因,无论该方是否事先被告知可能发生此类损害。

Note: The CDISC Intellectual Property Policy can be found at: cdisc_policy_003_intellectual_property_v201408.pdf.