CDISC的ADaMIG (V1.2) 中英文对照【5】_第五章 附录

本AdaMIG (v1.2)来自CDISC官网以下链接：

https://www.cdisc.org/standards/foundational/adam/adam-implementation-guide-v1-2-release-package

本章为最终章。

 

5 Appendices附录

Appendix A: Abbreviations and Acronyms附录A：缩写词和首字母缩写词

The following is a list of abbreviations and acronyms used multiple times in this document. Not included here are explanations of the various SDTM domains (e.g., QS, DM). Also not included is a description of the variables referenced. 以下是本文档中多次使用的缩写和首字母缩略词的列表。这里不包括各种SDTM域（例如QS，DM）的说明。也未包括所引用变量的描述。

 

ADaM	CDISC Analysis Data Model【CDISC分析数据模型】
ADaM Model document	The document entitled "Analysis Data Model (ADaM)" 【标题为“分析数据模型（ADaM）”的文档】
ADaMIG	Analysis Data Model Implementation Guide【分析数据模型实施指南】
ADSL	ADaM Subject-Level Analysis Dataset【ADaM受试者水平分析数据集】
BDS	ADaM Basic Data Structure【ADaM基本数据结构】
BLOCF	Baseline Observation Carried Forward【进行基线观察】
CBER	FDA Center for Biologics Evaluation and Research【FDA生物制品评估与研究中心】
CDASH	Clinical Data Acquisition Standards Harmonization【临床数据采集标准的统一】
CDER	FDA Center for Drug Evaluation and Research【FDA药物评估与研究中心】
CDISC	Clinical Data Interchange Standards Consortium【临床数据交换标准协会】
CDRH	FDA Center for Devices and Radiological Health【FDA设备与放射卫生中心】
CRO	Contract Research Organization【合同研究组织】
DAO	Data as Observed【观察数据】
eCTD	electronic Common Technical Document【电子通用技术文件】
FDA	U.S. Food and Drug Administration【美国食品药品监督管理局】
ITT	Intent-to-Treat【意向治疗】
IVRS	Interactive Voice Response System【互动语音响应系统】
LOCF	Last Observation Carried Forward【最后的观察结转】
LOV	Last Observed Value【最后观察值】
LVPD	Last Value Prior to Dosing【给药前的最终值】
OCCDS	ADaM Occurrence Data Structure【ADaM发生数据结构】
PMDA	Pharmaceuticals and Medical Devices Agency (Japan)【药品和医疗器械局（日本】
SAP	Statistical Analysis Plan【统计分析计划】
SDTM	Study Data Tabulation Model【研究数据列表模型】
SDTMIG	Study Data Tabulation Model Implementation Guide【研究数据列表模型实施指南】
TAUG	Therapeutic Area User Guide【治疗区用户指南】
TCG	Technical Conformance Guide【技术符合性指南】
WOC	Worst Observed Case【观察到的最坏情况】
WOCF	Worst Observation Carried Forward【进行最差的观察】
XML	Extensible Markup Language【可扩展标记语言】

 

Appendix B: Revision History附录B：修订历史

This section lists changes in the ADaMIG from Version 1.1 to Version 1.2. 本节列出了ADaMIG从版本1.1到版本1.2的更改。

 

Section部分	Type 类型	Description描述
Section 1.2	Clarification	In place of a general reference to the CDISC website, specific website references were added for the Study Data Tabulation Model document and the SDTMIG.【代替对CDISC网站的一般引用，为研究数据列表模型文档和SDTMIG添加了特定的网站引用。】
Section 1.2	New	Added reference to the PMDA Technical Conformance Guide.【添加了对《 PMDA技术符合性指南》的引用。】
Section 1.3	Clarification	Removed version number from references to the OCCDS document and the FDA Technical Conformance Guide since the most current versions of these documents will always be applicable.【从对OCCDS文件和FDA技术符合性指南的引用中删除了版本号，因为这些文件的最新版本将始终适用。】
Section 1.3.1	Modification	Updated section to reference applicability of documents to Version 1.2 as well as Versions 1.0 and 1.1.【更新了本节，以引用文档对版本1.2以及版本1.0和1.1的适用性。】
Section 1.4	Clarification	Changed explanation of Section 4 from "…presents standard solutions for implementation issues, illustrated with examples" to "…provides important additional guidance".【将第4节的解释从“…提供实施问题的标准解决方案，以示例说明”更改为“…提供重要的附加指南”。】
Section 1.5.1	Modification	Defined the new term of "Scope"; sorted the terms alphabetically; and change the name of the section from "General ADaM Definitions" to "General ADaM Definitions and Concepts".【定义了“范围”的新术语；按字母顺序对术语进行排序；并将该部分的名称从“常规ADaM定义”更改为“常规ADaM定义和概念”。】
Section 1.5.2	Clarification	In the definition of Analysis parameter, "--STRESU" was added to the list of examples of SDTM qualifiers. In the definition of Analysis Value, the example of a derived analysis value for average heart rate was replace with one for body mass index. In the definition of Parameter-variant, AVALCATy was provided as an example of a parameter-variant variable.【在“分析”参数的定义中，“-STRESU”已添加到SDTM限定词的示例列表中。在分析值的定义中，将平均心率的推导分析值的示例替换为体重指数的示例。在参数变量的定义中，提供了AVALCATy作为参数变量的示例。】
Section 1.6.1	Clarification	Text re-written to acknowledge that the structure being provided in this section is an example and that requirements may vary across regulatory agencies.【重写文字以确认本节中提供的结构是一个示例，并且各个监管机构的要求可能会有所不同。】
Section 2.2	Clarification	Within the second set of bullets in the section, in the 1st bullet point, changed "Information that exists in the submitted SDTM data" to "In