本AdaMIG (v3.2)来自CDISC官网以下链接：
https://www.cdisc.org/standards/foundational/adam/adam-implementation-guide-v1-2-release-package
Analysis Data Model Implementation Guide
Version 1.2 (Final)
Prepared by the
CDISC Analysis Data Model Team
Notes to Readers
• This Implementation Guide is Version 1.2 and corresponds to Version 2.1 of the CDISC Analysis Data Model.
• 此实现指南是版本1.2，对应于CDISC分析数据模型的版本2.1。
Revision History
|
Date |
Version |
|
2019-10-03 |
1.2 Final |
|
2016-02-12 |
1.1 Final |
|
20009-12-17 |
1.0 Final |
CONTENTS 目录
1 INTRODUCTION （介绍）................................................................................................................. 4
1.1 PURPOSE （目的）................................................................................................................................................................ 4
1.2 BACKGROUND（背景）....................................................................................................................................................... 4
1.3 WHAT IS COVERED IN THE ADAMIG（本IG涵盖的内容）.................................................................................................................... 4
1.3.1 Other ADaM-related CDISC Documents（其他与ADaM相关的CDISC文档）............................................................................................... 5
1.4 ORGANIZATION OF THIS DOCUMENT *（本文档的结构）..................................................................................................................... 6
1.5 DEFINITIONS（定义）.......................................................................................................................................................... 6
1.5.1 General ADaM Definitions （通用ADaM定义）.................................................................................................................... 6
1.5.2 Basic Data Structure Definitions （基本数据结构定义）............................................................................................................ 7
1.6 ANALYSIS DATASETS AND ADAM DATASETS（分析数据集和ADaM数据集）....................................................................................................... 7
1.6.1 Analysis Datasets Within the eCTD Folder Structure（分析eCTD文件夹结构中的数据集）............................................................................ 8
2 FUNDAMENTALS OF THE ADAM STANDARD （ADaM标准的基础）......................................................... 10
2.1 FUNDAMENTAL PRINCIPLES （基本原则）................................................................................................................................ 10
2.2 TRACEABILITY（可追溯性）.................................................................................................................................................... 10
2.3 THE ADAM DATA STRUCTURES ADaM（数据结构）......................................................................................................................... 11
2.3.1 The ADaM Subject-Level Analysis Dataset (ADSL) ADaM（受试者级别分析数据集(ADSL)）.......................................................................... 11
2.3.2 The ADaM Basic Data Structure (BDS)（ADaM基本数据结构(BDS)）.............................................................................................. 12
3 STANDARD ADAM VARIABLES（标准ADaM变量）................................................................................... 13
3.1 ADAM VARIABLE CONVENTIONS （ADaM变量约定）....................................................................................................................... 13
3.1.1 General Variable Conventions（通用变量约定）............................................................................................................. 13
3.1.2 Timing Variable Conventions（时间变量约定）.............................................................................................................. 15
3.1.3 Date and Time Imputation Flag Variables（日期和时间的输入标记变量）........................................................................................... 16
3.1.4 Flag Variable Conventions（标志变量约定）................................................................................................................... 17
3.1.5 Variable Naming Fragments（变量命名片段）................................................................................................................. 18
3.1.6 Additional Information about Section 3（关于第3节的其他信息）............................................................................................... 20
3.2 ADSL VARIABLES ADSL变量.............................................................................................................................................. 21
3.3 ADAM BASIC DATA STRUCTURE (BDS) VARIABLES（ADaM基本数据结构变量）.......................................................................................... 34
3.3.1 Identifier Variables for BDS （Datasets BDS数据集的标识符变量）.................................................................................................. 34
3.3.2 Record-Level Treatment and Dose Variables for BDS Datasets *（BDS数据集纪录级别的用药（Treatment）和剂量变量）.......................................................... 35
3.3.3 Timing Variables for BDS Datasets（BDS数据集的时间变量）..................................................................................................... 37
3.3.4 Analysis Parameter Variables for BDS Datasets .（BDS数据集的分析参数变量）................................................................................. 44
3.3.4.1 Analysis Parameter Variables（分析参数变量）............................................................................................................... 44
3.3.4.2 PARAM, AVAL, and AVALC ............................................................................................................ 49
3.3.4.3 Analysis Parameter Criteria Variables for BDS Datasets（BDS数据集的分析参数标准变量）..................................................................... 50
3.3.5 Analysis Descriptor Variables for BDS（Datasets BDS数据集的分析描述符变量）................................................................................. 51
3.3.6 Time-to-Event Variables for BDS Datasets（BDS数据集的时间-事件变量）......................................................................................... 53
3.3.7 Toxicity and Range Variables for BDS Datasets （BDS数据集的毒性和范围变量）................................................................................. 53
3.3.8 Indicator Variables for BDS Datasets（BDS数据集的指标变量）.................................................................................................. 57
3.3.9 Datapoint Traceability Variables （数据可追溯性变量）.......................................................................................................... 60
3.4 ANALYSIS-ENABLING VARIABLES （可分析变量）...................................................................................................................... 61
3.5 DIFFERENCES BETWEEN SDTM AND ADAM POPULATION AND BASELINE FLAGS （SDTM和ADAM种群和基线标志之间的差异）............................................. 61
4 IMPLEMENTATION ISSUES, STANDARD SOLUTIONS, AND EXAMPLES（实现问题、标准解决方案和示例） ........ 62
4.1 EXAMPLES OF TREATMENT VARIABLES FOR COMMON TRIAL DESIGNS （常见试验设计的治疗变量示例）.............................................................. 62
4.2 CREATION OF DERIVED COLUMNS VERSUS CREATION OF DERIVED ROWS（创建派生列vs创建派生行） ......................................................... 64
4.2.1 Rules for the Creation of Rows and Columns （创建行和列的规则）...................................................................................... 65
4.2.1.1 Rule 1: A parameter-invariant function of AVAL and BASE on the same row that does not involve a transform of BASE should be added as a new column.（规则1:在同一行中不涉及BASE变换的AVAL和BASE的参数不变函数应添加为新列） ........................................................................................ 65
4.2.1.2 Rule 2: A transformation of AVAL that does not meet the conditions of Rule 1 should be added as a new parameter, and AVAL should contain the transformed value.（规则2:不满足规则1条件的AVAL转换应作为新参数添加，AVAL应包含转换后的值。） ...................................................................... 66
4.2.1.3 Rule 3: A function of one or more rows within the same parameter for the purpose of creating an analysis timepoint should be added as a new row for the same parameter. （规则3:为了创建分析时间点，在同一个参数中包含一行或多行的函数应该作为同一参数的新行添加。）.......................................................... 68
4.2.1.4 Rule 4: A function of multiple rows within a parameter should be added as a new parameter. （规则4:一个参数中的多行函数应该作为新参数添加。）........... 73
4.2.1.5 Rule 5: A function of more than one parameter should be added as a new parameter.（规则5:具有多个参数的函数应该作为新参数添加。） ........................ 75
4.2.1.6 Rule 6: When there is more than one definition of baseline, each additional definition of baseline requires the creation of its own set of rows. （规则6:当有多个基线定义时，每一个额外的基线定义都需要创建自己的行集。）......................................................................................................... 76
4.3 INCLUSION OF ALL OBSERVED AND DERIVED RECORDS FOR A PARAMETER VERSUS THE SUBSET OF RECORDS USED FOR ANALYSIS （包含参数的所有观察和派生记录，而不是用于分析的记录子集）.................................................................................................................................................... 78
4.4 INCLUSION OF INPUT DATA THAT ARE NOT ANALYZED BUT THAT SUPPORT A DERIVATION IN THE ADAM DATASET （包含未被分析但在ADAM数据集中支持派生的输入数据）...................................................................................................................................................................... 81
4.5 IDENTIFICATION OF RECORDS USED FOR ANALYSIS （用于分析的记录的识别）............................................................................................ 85
4.5.1 Identification of Records Used in a Timepoint Imputation Analysis（在时间点归责分析中使用的记录的识别） ................................................... 85
4.5.2 Identification of Baseline Records（基线记录的识别） ....................................................................................................... 87
4.5.3 Identification of Post-Baseline Conceptual Timepoint Records（确定基线后概念时间点记录） ........................................................... 88
4.5.4 Identification of Records Used for Analysis – General Case（用于分析的记录的识别。一般情况） ............................................................... 90
4.6 IDENTIFICATION OF POPULATION-SPECIFIC ANALYZED RECORDS（识别特定人群的分析记录） ...................................................................... 92
4.7 IDENTIFICATION OF RECORDS WHICH SATISFY A PREDEFINED CRITERION FOR ANALYSIS PURPOSES （为分析目的而确定满足预定义标准的记录）................. 95
4.7.1 When the Criterion Has Binary Responses （当准则有二进制响应时）.......................................................................................... 95
4.7.2 When the Criterion Has Multiple Responses（当标准有多个响应时） ....................................................................................... 98
4.8 EXAMPLES OF TIMING VARIABLES（定时变量的例子） .................................................................................................................... 100
4.9 EXAMPLES OF BI-DIRECTIONAL LAB TOXICITY VARIABLES（双向实验室毒性变量的例子） ............................................................................. 100
4.10 OTHER ISSUES TO CONSIDER（其他需要考虑的问题） ............................................................................................................................. 102
4.10.1 Adding Records to Create a Full Complement of Analysis Timepoints for Every Subject（添加记录，为每个主题创建完整的分析时间点）................ 102
4.10.2 Creating Multiple Datasets to Support Analysis of the Same Type of Data.（创建多个数据集以支持对同一类型数据的分析）...................................... 102
4.10.3 Size of ADaM Datasets (ADaM数据集的大小)...................................................................................................................... 102
4.10.4 Traceability when the Multiple Imputation Method Is Used (使用多重归责法时的可追溯性).............................................................. 102
4.10.5 Copying Values onto a New Record(将值复制到新记录) .................................................................................................. 103
5 APPENDICES 附录 .................................................................................................................... 104
APPENDIX A: ABBREVIATIONS AND ACRONYMS （附录A:缩写和首字母缩写）........................................................................................................104
APPENDIX B: REVISION HISTORY（附录B:修订历史） .............................................................................................................................. 105
APPENDIX C: REPRESENTATIONS AND WARRANTIES, LIMITATIONS OF LIABILITY, AND DISCLAIMERS （附录C:声明与保证、责任限制和免责声明） ......................110
1 Introduction 介绍
1.1 Purpose 目的
This document comprises the Clinical Data Interchange Standards Consortium (CDISC) Version 1.2 of the Analysis Data Model Implementation Guide (ADaMIG), which has been prepared by the CDISC Analysis Data Model (ADaM) Team. The ADaMIG specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues.
本文档包括分析数据模型实施指南（ADaMIG）的临床数据交换标准协会（CDISC）版本1.2，该指南由CDISC分析数据模型（ADaM）团队编写。 ADaMIG指定ADaM标准数据集结构和变量，包括命名约定。它还指定了实施问题的标准解决方案。
The ADaMIG must be used in close concert with the current version of the document titled "Analysis Data Model (ADaM)," which is available for download at http://www.cdisc.org/adam. That 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 ADaM datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of submitted ADaM datasets. The Analysis Data Model supports efficient generation, replication, and review of analysis results.
必须与标题为“分析数据模型（ADaM）”的文档的当前版本紧密配合使用ADaMIG，该文档可从http://www.cdisc.org/adam下载。该文档解释了分析数据模型的目的。它描述了适用于所有分析数据集的基本原理，其驱动原理是ADaM数据集和相关元数据的设计有助于显式传达提交的ADaM数据集的内容，输入和用途。分析数据模型支持有效生成，复制和查看分析结果。
Note that in the remainder of the ADaMIG, the document titled "Analysis Data Model (ADaM)" is referred to as the ADaM Model document.
请注意，在ADaMIG的其余部分中，标题为“分析数据模型（ADaM）”的文档称为ADaM模型文档。
1.2 Background 背景
Readers of the ADaMIG should be familiar with the CDISC Study Data Tabulation Model (SDTM), which is available at https://www.cdisc.org/standards/foundational/sdtm, and the Study Data Tabulation Model Implementation Guide: Human Clinical Trials (SDTMIG), available at https://www.cdisc.org/standards/foundational/sdtmig, because SDTM datasets are the source for ADaM data.
ADaMIG的读者应该熟悉https://www.cdisc.org/standards/foundational/sdtm上提供的CDISC研究数据列表模型（SDTM），以及《研究数据列表模型实施指南：人类临床试验》（SDTMIG），网址为https://www.cdisc.org/standards/foundational/sdtmig，因为SDTM数据集是ADaM数据的来源。
The SDTM and ADaM standards were designed to support submission to a regulatory agency such as the U.S. Food and Drug Administration (FDA). Since inception, the CDISC ADaM Team has been encouraged and informed by FDA statistical and medical reviewers who participate in ADaM meetings as observers, and who have participated in CDISC-FDA pilots. The origin of the fundamental principles of ADaM was the need for transparency of communication with and scientifically valid review by regulatory agencies. The ADaM standard has been developed to meet the needs of the FDA and industry. ADaM is applicable to a wide range of drug development activities in addition to FDA regulatory submissions. It provides a standard for transferring datasets between sponsors and contract research organizations (CROs), development partners, and independent data monitoring committees. ADaM supports efficient data sharing among pharmaceutical sponsors, CROs, and any partners involved in in-licensing, out-licensing, or mergers.
SDTM和ADaM标准旨在支持向监管机构（例如美国食品和药物管理局（FDA））的提交。自成立以来，CDISC ADaM团队受到FDA统计人员和医学评审员的鼓励和告知，他们以观察员身份参加了ADaM会议，并参加了CDISC-FDA试点。 ADaM基本原则的起源是与监管机构保持沟通透明和科学有效审查的需要。已经开发了ADaM标准来满足FDA和行业的需求。除FDA法规要求外，ADaM还适用于广泛的药物开发活动。它提供了在发起人和合同研究组织（CRO），开发合作伙伴以及独立数据监控委员会之间传输数据集的标准。 ADaM支持在药品赞助商，CRO和参与许可内，许可外或合并的任何合作伙伴之间进行有效的数据共享。
In addition, readers of the ADaMIG should be aware of information provided by the FDA. Specifically, the FDA website has a central location for the posting of FDA regulations and guidance documents that relate to data standards. The main page, "Study Data Standards Resources," contains links to important documents, both published and draft, for Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). One such document is the Study Data Technical Conformance Guide, which is referred to in this implementation guide as the FDA TCG. Readers should also be aware that, for other regulatory agencies, other TCGs exist, such as the Pharmaceuticals and Medical Devices Agency (PMDA) TCG for Japan submissions (http://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0002.html).
此外，ADaMIG的读者应了解FDA提供的信息。具体地说，FDA网站位于中心位置，用于发布与数据标准有关的FDA法规和指导文件。主页“研究数据标准资源”包含指向药物评估和研究中心（CDER），生物制品评估和研究中心（CBER）和设备与放射卫生中心的重要文件（已发布和草稿）的链接。 （CDRH）（http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm）。其中一项文件是《研究数据技术符合性指南》，在该实施指南中称为FDA TCG。读者还应注意，对于其他监管机构，还存在其他TCG，例如日本药品和医疗器械局（PMDA）TCG（(http://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0002.html).
1.3 What Is Covered in the ADaMIG 本ADaMIG涵盖的内容
This document describes two ADaM standard data structures: the Subject-Level Analysis Dataset (ADSL) and the Basic Data Structure (BDS). The third ADaM standard data structure, the Occurrence Data Structure (OCCDS), is described in the document "ADaM Structure for Occurrence Data (OCCDS)".
本文档描述了两个ADaM标准数据结构：主题级分析数据集（ADSL）和基本数据结构（BDS）。第三个ADaM标准数据结构，即出现数据结构（OCCDS），在文档“出现数据的ADaM结构（OCCDS）”中进行了描述。
The ADSL dataset contains one record per subject. It contains variables including, but not limited to, subject-level population flags, planned and actual treatment variables for each period, demographic information, stratification and subgrouping variables, and important dates. ADSL contains required variables (as specified in this document) plus other subject-level variables that are important in describing a subject’s experience in the trial. ADSL and its related metadata are required in a CDISC-based submission of data from a clinical trial, even if no other ADaM datasets are submitted. Note that this ADaM requirement is also discussed in the FDA TCG.
ADSL数据集每个主题包含一个记录。它包含变量，包括但不限于受试者水平的人群标志，每个时期的计划和实际治疗变量，人口统计信息，分层和子分组变量以及重要日期。 ADSL包含必需的变量（如本文档中所指定）以及其他主体级别的变量，这些变量对于描述主体在试验中的体验很重要。即使没有其他ADaM数据集提交，基于CDISC的临床试验数据提交也需要ADSL及其相关元数据。请注意，FDA TCG中也讨论了此ADaM要求。
A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is not required; it is dependent on the analysis. In situations where there is no analysis timepoint, the structure is one or more records per subject per analysis parameter. This structure contains a central set of variables that represent the actual data being analyzed. The BDS supports parametric and nonparametric analyses such as analysis of variance (ANOVA), analysis of covariance (ANCOVA), categorical analysis, logistic regression, Cochran-Mantel-Haenszel test, Wilcoxon rank-sum test, time-to-event analysis.
BDS数据集包含每个主题，每个分析参数，每个分析时间点的一个或多个记录。不需要分析时间点；它取决于分析。在没有分析时间点的情况下，结构是每个受试者每个分析参数一个或多个记录。此结构包含一组中心变量，这些变量代表要分析的实际数据。 BDS支持参数分析和非参数分析，例如方差分析（ANOVA），协方差分析（ANCOVA），分类分析，逻辑回归，Cochran-Mantel-Haenszel检验，Wilcoxon秩和检验，事件发生时间分析。
Though the BDS supports most statistical analyses, it does not support all statistical analyses. For example, it does not support simultaneous analysis of multiple dependent (response/outcome) variables or a correlation analysis across a range of response variables.
尽管BDS支持大多数统计分析，但它不支持所有统计分析。例如，它不支持同时分析多个因变量（响应/结果）或跨一系列响应变量进行相关性分析。
The BDS was not designed to support analysis of incidence of adverse events or other occurrence data. Analysis of such data is supported in the OCCDS.
BDS并非旨在支持不良事件发生率或其他发生数据的分析。 OCCDS支持对此类数据进行分析。
This version of the implementation guide does not fully cover dose-escalation trials or integration of multiple studies.
该版本的实施指南未完全涵盖剂量递增试验或多项研究的整合。
1.3.1 Other ADaM-related CDISC Documents 其他与ADaM相关的CDISC文档
Other CDISC documents relevant to the ADaM standard have been produced by the ADaM Team, or by the ADaM Team in concert with other CDISC teams. The most current versions of these documents can be found on the CDISC website, at https://www.cdisc.org/standards/foundational/adam. Table 1.3.1.1 lists the documents available at the time of publication of ADaMIG v1.2 and describes their applicability to ADaMIG versions 1.0, 1.1, and 1.2.
其他与ADaM标准相关的CDISC文件是由ADaM团队或由ADaM团队与其他CDISC团队协作制作的。 这些文档的最新版本可以在CDISC网站上找到，网址为https://www.cdisc.org/standards/foundational/adam。 表1.3.1.1列出了发布ADaMIG v1.2时可用的文档，并描述了它们对ADaMIG 1.0、1.1和1.2版本的适用性。
Table 1.3.1.1 Other CDISC Documents and Their Applicability to ADaMIG Versions
表 1.3.1.1其他CDISC文档及其对ADaMIG版本的适用性
|
Document |
ADaMIG v1.0 |
ADaMIG v1.1 |
ADaMIG v1.2 |
|
Analysis Data Model (ADaM) v2.1, December 2009 |
Foundational document for ADaMIG v1.0 |
Applicable |
Applicable |
|
ADaM Examples in Commonly Used Statistical Analysis Methods v1.0, December 2011 |
Written for ADaMIG v1.0 |
Applicable |
Applicable |
|
The ADaM Basic Data Structure for Time-to-Event Analyses v1.0, May 2012 |
Written for ADaMIG v1.0 |
Applicable |
Applicable |
|
Update to the first CDISC SDTM/ADaM Pilot Project, January 2013 |
Written for ADaMIG v1.0 |
Applicable |
Applicable |
|
ADaM Data Structure for Adverse Event Analysis v1.0, May 2012 |
Written for ADaMIG v1.0 |
Superseded by OCCDS v1.0 |
Superseded by OCCDS v1.0 |
|
ADaM Occurrence Data Structure (OCCDS) v1.0, February, 2016 |
Not written for ADaMIG v1.0 |
Written for ADaMIG v1.1 |
Applicable |
|
CDISC ADaM Conformance Rules v2.0, March 2019 |
Applicable |
Applicable |
Mostly applicable |
|
Define-XML v2.0, March 2013 |
Applicable |
Applicable |
Applicable |
|
Analysis Results Metadata Specification for Define-XML Version 2 v1.0, January 2015 |
Applicable |
Applicable |
Applicable |
As shown in Table 1.3.1.1, for a particular version of the ADaMIG, documents with different release dates are often used together. If there are conflicts among the documents applicable to a particular version of the ADaMIG, the best practice is to use the content from the document with the most recent publication date.
The ADaM Team is currently working on additional ADaM standard documents addressing the following topics:
• Integration of multiple studies
• Pharmacokinetics
• Oncology
• Questionnaires, ratings, and scales
如表1.3.1.1所示，对于特定版本的ADaMIG，通常将具有不同发布日期的文档一起使用。 如果适用于特定版本ADaMIG的文档之间存在冲突，则最佳实践是使用文档中具有最新发布日期的内容。ADaM团队目前正在研究涉及以下主题的其他ADaM标准文档：
•整合多项研究
•药代动力学
•肿瘤科
•问卷，评分和量表
Some CDISC Therapeutic Area User Guides (TAUGs) are released in draft, provisional, or final versions that discuss analysis and propose approaches to ADaM implementation. These documents are useful to implementers of the ADaM standard, but do not officially comprise part of the ADaM standard until such time as the ADaM Team incorporates these recommendations in a release of the foundational standard.
一些CDISC治疗领域用户指南（TAUG）以草案，临时或最终版本发布，讨论了分析并提出了实施ADaM的方法。 这些文档对于ADaM标准的实施者很有用，但直到ADaM团队将这些建议纳入基础标准发布之时，才正式成为ADaM标准的一部分。
1.4 Organization of this Document 本IG的结构
This document is organized into the following sections:
本文档分为以下几节：
• Section 1, Introduction, provides an overall introduction to the importance of the ADaM standard and how it relates to other CDISC data standards.
•第1节“简介”全面介绍了ADaM标准的重要性以及它与其他CDISC数据标准的关系。
• Section 2, Fundamentals of the ADaM Standard, provides a review of the fundamental principles that apply to all analysis datasets and introduces two standard structures that are flexible enough to represent the great majority of analysis situations.
•第2节“ ADaM标准的基础知识”回顾了适用于所有分析数据集的基本原理，并介绍了两个标准结构，这些结构足够灵活以表示绝大多数分析情况。
• Section 3, Standard ADaM Variables, defines standard variables that are commonly used in the ADaM standard data structures.
•第3节“标准ADaM变量”定义ADaM标准数据结构中常用的标准变量。
• Section 4, Implementation Issues, Standard Solutions, and Examples, provides important additional guidance.
•第4节，实施问题，标准解决方案和示例，提供了重要的附加指导。
• Appendices provide additional background material and describe other supplemental material relevant to implementation.
•附录提供了其他背景材料，并描述了与实施相关的其他补充材料。
Throughout this document the terms "producer" and "consumer" are used to refer to the originator/sender/owner/sponsor of the data and the reviewer/user/recipient of the data, respectively. These terms are used to simplify the document and to avoid any implication that the statements made in the document only apply to ADaM datasets in the context of electronic submissions to regulatory agencies.
在整个文件中，术语“生产者”和“消费者”分别指数据的始发者/发送者/所有者/赞助者和数据的审阅者/用户/接收者。 这些术语用于简化文档，并避免暗示在文档中的声明仅在以电子方式提交给监管机构的情况下适用于ADaM数据集。
1.5 Definitions 定义
1.5.1 General ADaM Definitions 通用ADaM定义
Analysis-enabling – Required for analysis. A column or row in an ADaM dataset is analysis-enabling if it is required to perform the analysis. Examples: a hypertension category column added to the ADaM dataset to enable subgroup analysis, an age covariate added to enable the analysis to be age-adjusted, a center stratification factor in a multicenter study.
支持分析–分析所需。如果需要执行分析，则ADaM数据集中的列或行将启用分析。示例：在ADaM数据集中添加了一个高血压类别列，以进行子组分析；添加了年龄协变量，以使该分析可以进行年龄调整；这是多中心研究中的中心分层因素。
Record – A row in a dataset. A record is also referred to as an "observation" within this document.
记录–数据集中的一行。记录在本文档中也称为“观察”。
Scope – The extent or range within which an ADaMIG requirement applies (e.g., within a study, within a dataset, within a parameter, or within a specified subset of rows within a parameter). For example, AVALCATy is a categorization of AVAL or AVALC within a parameter. In this example, "within a parameter" is the scope of the statement, "AVALCATy is a categorization of AVAL". Throughout the ADaMIG, scope is often conveyed in sentences containing the text "within a ...".
范围–适用ADaMIG要求的范围或范围（例如，在研究内，数据集中，参数内或参数内行的指定子集内）。例如，AVALCATy是参数中AVAL或AVALC的分类。在此示例中，“参数内”是语句的范围，“ AVALCATy是AVAL的分类”。在整个ADaMIG中，范围通常以包含文本“……内”的句子传达。
Supportive – A column or row in an ADaM dataset is supportive if it is not required in order to perform an analysis but is included in order to facilitate traceability or review. Example: The LBSEQ and VISIT columns were carried over from the SDTM dataset in order to promote understanding of how the ADaM dataset rows relate to the study tabulation dataset.
支持性– ADaM数据集中的列或行不是进行分析所必需的，而是包含在其中以方便可追溯性或复查性的。示例：LBSEQ和VISIT列是从SDTM数据集继承而来的，以增进对ADaM数据集行与研究列表数据集的关系的了解。
Traceability – The property that enables the understanding of the data's lineage and/or the relationship between an element and its predecessor(s). Traceability facilitates transparency, which is an essential component in building confidence in a result or conclusion. Ultimately, traceability permits the understanding of the relationship between the analysis results, the ADaM datasets, the SDTM datasets, and the data collection instrument. Traceability is built by clearly establishing the path between an element and its immediate predecessor. The full path is traced by going from one element to its predecessors, then on to their predecessors, and so on, back to the SDTM datasets, and ultimately to the data collection instrument.
可追溯性–一种属性，使您能够了解数据的沿袭和/或元素与其前身之间的关系。可追溯性有助于提高透明度，这是建立对结果或结论的信心的重要组成部分。最终，可追溯性使您可以了解分析结果，ADaM数据集，SDTM数据集和数据收集工具之间的关系。可追溯性是通过明确建立元素与其前身之间的路径而建立的。从一个元素到其前任，然后再到其前任，依此类推，再回到SDTM数据集，最后到数据收集工具，可以跟踪完整路径。
Variable – A column in a dataset.
变量–数据集中的一列。
1.5.2 Basic Data Structure Definitions 基本数据结构定义
Analysis parameter – A row identifier used to characterize uniquely a group of values that share a common definition. Note that the ADaM analysis parameter contains all of the information needed to identify uniquely a group of related analysis values. In contrast, the SDTM --TEST column may need to be combined with qualifier columns such as --STRESU, --POS, --LOC, --SPEC, in order to identify a group of related values. In this document the word "parameter" is used as a synonym for "analysis parameter". Example: The primary efficacy analysis parameter is "Sitting Systolic Blood Pressure (mmHg)".
分析参数–行标识符，用于唯一地表征一组具有共同定义的值。请注意，ADaM分析参数包含唯一标识一组相关分析值所需的所有信息。相比之下，SDTM --TEST列可能需要与诸如--STRESU，-POS，-LOC，-SPEC之类的限定符列组合，以标识一组相关值。在本文中，单词“参数”被用作“分析参数”的同义词。示例：主要功效分析参数是“坐式收缩压（mmHg）”。
Analysis timepoint – A row identifier used to classify values within an analysis parameter into temporal or conceptual groups used for analyses. These groupings may be observed, planned, or derived. Example: The primary efficacy analysis was performed at the Week 2, Week 6, and Endpoint analysis timepoints.
分析时间点–行标识符，用于将分析参数中的值分类为用于分析的时间或概念组。这些分组可以被观察，计划或导出。示例：主要功效分析是在第2周，第6周和终点分析时间点进行的。
Analysis value – (1) The numeric (AVAL) or character (AVALC) value described by the analysis parameter. The analysis value may be present in the input data, a categorization of an input data value, or derived. Example: The analysis value of the parameter "Body Mass Index" was derived in an ADaM dataset from collected height and collected weight. (2) In addition, values of certain functions are considered to be analysis values. Examples: baseline value (BASE), change from baseline (CHG).
分析值–（1）分析参数描述的数字（AVAL）或字符（AVALC）值。分析值可以存在于输入数据中，输入数据值的分类中或导出。示例：在ADaM数据集中，从收集的身高和体重中得出参数“身体质量指数”的分析值。 （2）另外，某些功能的值被认为是分析值。示例：基线值（BASE），从基线（CHG）的变化。
Parameter-variant – A column that is derived as a function of AVAL (or AVALC) is parameter-variant if it is calculated differently for some parameters for which the variable is populated in a dataset. Thus, a column is parameter-variant if how it is derived depends on which parameter is on the row. For example, AVALCATy categorizes AVAL (or AVALC). The categories may differ depending on the parameter, which makes AVALCATy parameter-variant.
Parameter-variant（参数变量）–如果对某些参数（该变量在数据集中填充）的计算方式不同，则根据AVAL（或AVALC）派生的列将是参数变量。因此，如果列的派生方式取决于行中的参数，则该列将是参数变量。例如，AVALCATy将AVAL（或AVALC）分类。根据参数的不同，类别可能有所不同，这会使AVALCATy参数发生变化。
Parameter-invariant – A column that is derived as a function of AVAL (or AVALC) is parameter-invariant if it is calculated the same way for all parameters for which the variable is populated in a dataset. Thus, a column is parameter-invariant if how it is derived does not depend on which parameter is on the row. The parameter-invariant derivation remains the same across all parameters, though it may be left null for parameters where it does not apply. For example, the derivation for the change from baseline variable is CHG=AVAL-BASE, an equation that is the same for all parameters. CHG is therefore a parameter-invariant variable. The concept of parameter invariance is essential to the integrity of the BDS because it is an integral component in the rules defined in Section 4.2, Creation of Derived Columns Versus Creation of Derived Rows, that prohibit "horizontalization" (creation of new columns when the model dictates that a new row is required instead) by producers.
参数不变–如果以相同的方式对数据集中填充了该变量的所有参数进行计算，则作为AVAL（或AVALC）函数得出的列将是参数不变的。因此，如果列的派生方式不取决于行中的参数，则该列是参数不变的。参数不变推导在所有参数中都保持不变，尽管对于不适用的参数可以将其保留为空。例如，从基线变量的变化推导为CHG = AVAL-BASE，该方程对于所有参数都是相同的。因此，CHG是参数不变的变量。参数不变性的概念对于BDS的完整性至关重要，因为它是第4.2节“派生列的创建与派生行的创建”中定义的规则中不可或缺的组成部分，该规则禁止“水平化”（模型创建新列时）指示生产者改为需要新行。
1.6 Analysis Datasets and ADaM Datasets 分析数据集和ADaM数据集
The section compares and contrasts analysis datasets in general versus ADaM datasets in particular.
本节将一般分析数据集与特别是ADaM数据集进行比较和对比。
Analysis dataset – An analysis dataset is a dataset used for analysis and reporting.
分析数据集–分析数据集是用于分析和报告的数据集。
ADaM dataset – An ADaM dataset is a particular type of analysis dataset that either:
ADaM数据集– ADaM数据集是一种特殊类型的分析数据集，它可以：
1. is compliant with one of the ADaM defined structures and follows the ADaM fundamental principles, or 符合1.ADaM定义的结构之一并遵循ADaM基本原理，或
2. follows the ADaM fundamental principles defined in the ADaM Model document and adheres as closely as possible to the ADaMIG variable naming and other conventions.
2.遵循ADaM模型文档中定义的ADaM基本原则，并尽可能遵守ADaMIG变量命名和其他约定。
Non-ADaM analysis dataset – A non-ADaM analysis dataset is an analysis dataset that is not an ADaM dataset. Examples of non-ADaM analysis datasets include:
• An analysis dataset created according to a legacy company standard
• An analysis dataset that does not follow the ADaM fundamental principles
非ADaM分析数据集–非ADaM分析数据集是不是ADaM数据集的分析数据集。非ADaM分析数据集的示例包括：
•根据旧公司标准创建的分析数据集
•不遵循ADaM基本原则的分析数据集
It is important not to refer to non-ADaM analysis datasets as "ADaM datasets."
重要的是不要将非ADaM分析数据集称为“ ADaM数据集”。
To prevent confusion, non-ADaM analysis dataset names should not start with the prefix AD. It is good practice to start the names of non-ADaM analysis datasets with the two-letter prefix "AX" (see Figure 1.6.1).
为避免混淆，非ADaM分析数据集名称不应以前缀AD开头。优良作法是以两个字母的前缀“ AX”开头非ADaM分析数据集的名称（请参见图1.6.1）。
Currently ADaM has three structures: ADSL, BDS, and OCCDS, which correspond to the SUBJECT LEVEL ANALYSIS DATASET, BASIC DATA STRUCTURE, and OCCURRENCE DATA STRUCTURE classes of ADaM datasets. Analysis datasets that follow the ADaM fundamental principles and other ADaM conventions, but which do not follow one of the three defined structures (ADSL, BDS, OCCDS), are considered to be ADaM datasets with a class of ADAM OTHER. Controlled Terminology for the class element of the analysis dataset metadata can be downloaded at http://www.cdisc.org/terminology.
当前，ADaM具有三种结构：ADSL，BDS和OCCDS，它们对应于ADaM数据集的“对象级别分析数据集”，“基本数据结构”和“发生数据结构”类。遵循ADaM基本原理和其他ADaM约定但不遵循三个定义的结构（ADSL，BDS，OCCDS）之一的分析数据集被视为具有ADAM OTHER类的ADaM数据集。可以从http://www.cdisc.org/terminology下载分析数据集元数据的类元素的受控术语。
In the ADaM Model document, it is assumed that the original data sources for ADaM datasets are SDTM datasets, even when ADaM datasets are derived from other ADaM datasets. ADaM has features that enable traceability from analysis results to ADaM datasets and from ADaM datasets to SDTM datasets.
当前，ADaM具有三种结构：ADSL，BDS和OCCDS，它们对应于ADaM数据集的“对象级别分析数据集”，“基本数据结构”和“发生数据结构”类。遵循ADaM基本原理和其他ADaM约定但不遵循三个定义的结构（ADSL，BDS，OCCDS）之一的分析数据集被视为具有ADAM OTHER类的ADaM数据集。可以从http://www.cdisc.org/terminology下载分析数据集元数据的类元素的受控术语。
Figure 1.6.1 Categories of Analysis Datasets 分析数据集的类别
1.6.1 Analysis Datasets Within the eCTD Folder Structure 分析eCTD文件夹结构中的数据集
Regulatory agencies may have a specification for organizing datasets and their associated files in folders within a submission. An example is summarized in Figure 1.6.1.1, copied from the FDA TCG. For ease of use with the define file and in the eCTD (electronic Common Technical Document) folder structure, all analysis datasets should be kept in one folder. If a set of analysis datasets includes an ADaM-compliant ADSL dataset (as required for a CDISC-conformant submission), then the whole set of analysis datasets should be placed into the adam folder. If not, the whole set of analysis datasets should be placed into the legacy folder. Note that other agencies such as the PMDA may have different requirements, and other TCGs should be consulted for non-FDA submissions, as applicable.
监管机构可能有一个规范，用于组织提交中的文件夹中的数据集及其相关文件。 从FDA TCG复制的图1.6.1.1中总结了一个示例。 为了便于使用定义文件和eCTD（电子通用技术文档）文件夹结构，所有分析数据集都应保存在一个文件夹中。 如果一组分析数据集包括符合ADaM的ADSL数据集（符合CDISC提交要求），则应将整个分析数据集放置在adam文件夹中。 如果不是，则应将整个分析数据集的整个集合放入旧文件夹中。 请注意，其他机构（例如PMDA）可能有不同的要求，如果适用，应咨询其他TCG以获取非FDA提交的文件。
Figure 1.6.1.1 Folder Structure for Study Datasets
图1.6.1.1研究数据集的文件夹结构
第一章结束。