CDISC的ADaMIG (V1.2) 中英文对照【2】_第二章 ADaM标准的基础

本AdaMIG (v1.2)来自CDISC官网以下链接：

ADaMIG v1.2 Release Package | CDISC

2 Fundamentals of the ADaM Standard ADaM标准的基础

2.1 Fundamental Principles 基本原则

ADaM datasets must adhere to certain fundamental principles as described in the ADaM Model document: ADaM数据集必须遵守ADaM模型文档中描述的某些基本原则:

• ADaM datasets and associated metadata must clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.

•ADaM数据集和相关的元数据必须清楚明确地传达支持临床研究中进行的统计分析的数据集的内容和来源。

• ADaM datasets and associated metadata must provide traceability to show the source or derivation of a value or a variable (i.e., the data's lineage or relationship between a value and its predecessor(s)). The metadata must identify when and how analysis data have been derived or imputed.

•ADaM数据集和关联的元数据必须提供可追溯性，以显示值或变量的来源或派生（即，数据的沿袭或值与其前身之间的关系）。元数据必须标识何时以及如何导出或估算分析数据。

• ADaM datasets must be readily usable with commonly available software tools.

•ADaM数据集必须易于与通用软件工具一起使用。

• ADaM datasets must be associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.

•ADaM数据集必须与元数据关联，以促进清晰明确的通信。理想情况下，元数据是机器可读的。

• ADaM datasets should have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready." ADaM datasets contain the data needed for the review and re-creation of specific statistical analyses. It is not necessary to collate data into analysis-ready datasets solely to support data listings or other non-analytical displays.

•ADaM数据集的结构和内容应允许以最少的编程即可进行统计分析。 此类数据集被描述为“分析就绪”。 ADaM数据集包含审查和重新创建特定统计分析所需的数据。 不必仅将数据整理到可用于分析的数据集中以支持数据列表或其他非分析显示。

Refer to the ADaM Model document (available at https://www.cdisc.org/standards/foundational/adam) for more details.

有关更多详细信息，请参阅ADaM模型文档（可从https://www.cdisc.org/standards/foundational/adam获取）。

2.2 Traceability 可追溯性

To assist review, ADaM datasets and metadata must clearly communicate how the ADaM datasets were created. The verification of derivations in an ADaM dataset requires having at hand the input data used to create the ADaM dataset. A CDISC-conformant submission includes both SDTM and ADaM datasets; therefore, it follows that the relationship between SDTM and ADaM must be clear. This requirement highlights the importance of traceability between the analyzed data (ADaM) and its input data (SDTM).

为了帮助审核，ADaM数据集和元数据必须清楚地传达如何创建ADaM数据集。验证ADaM数据集中的派生需要手头有用于创建ADaM数据集的输入数据。符合CDISC的提交包括SDTM和ADaM数据集；因此，因此必须明确SDTM和ADaM之间的关系。此要求突出了在分析数据（ADaM）及其输入数据（SDTM）之间进行可追溯性的重要性。

Traceability is built by clearly establishing the path between an element and its immediate predecessor. As described in Section 1.5.1, General ADaM Definitions & Concepts, 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.

可追溯性是通过明确建立元素与其直接前身之间的路径来构建的。如部分 1.5.1， 一般 ADaM