CDISC的SDTMIG，3.2版翻译和学习2---第二章 SDTM基础

2 Fundamentals of the SDTM SDTM基础

2.1 Observations and Variables 观测（数据）和变量

The V3.x Submission Data Standards are based on the SDTM’s general framework for organizing clinical trials information that is to be submitted to the FDA. The SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset or table. Each variable can be classified according to its Role. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into five major roles:

先前向FDA递交的一系列基于IG V3.X版本的数据格式都是基于SDTM的通用框架。SDTM是围绕受试者在临床试验中观测数据的一系列概念创建。每一条观测数据通过一系列的变量，即表格中的不同列，进行描述。每一个变量可以根据其角色类型进行分类。对于每一条不重复观测，变量的角色决定了变量如何传达信息和如何使用。变量可被归纳为以下5种主要角色：

• Identifier
variables, such as those that identify the study, subject, domain, and sequence number of the record
•标识符 (Identifier)变量：例如，用来标识研究本身、参与研究的受试者、域名以及记录序号等

• Topic variables, which specify the focus of the observation (such as the name of a lab test)
• 主题 (Topic)变量：指明观测记录的主要目的（例如，某一实验室检测的名称）

• Timing variables, which describe the timing of the observation (such as start date and end date)
• 时间 (Timing)变量：描述观测记录的时间（例如，开始时间和结束时间）

• Rule variables, which express an algorithm or executable method to define start, end, and branching or looping conditions in the Trial Design model
• 规则变量：在试验设计模型里，表达一种算法或可执行的方法，来定义其开始或结束，分流或循环等条件

• Qualifier variables, which include additional illustrative text or numeric values that describe the results or additional traits of the observation (such as units or descriptive adjectives)
• 修饰语 (Qualifier)变量：包括用来进一步描述结果的说明性文字或者数值，或观测记录的更多特征（例如，单位或描述性形容词）

The set of Qualifier variables can be further categorized into
five sub-classes: 修饰变量可进一步细分为五个子类别：

• Grouping Qualifiers are used to group together a collection of observations within the same domain. Examples include --CAT and --SCAT.
• 分组修饰语 (Grouping Qualifiers) ：对同一域中的数据分组。例如：–CAT 和 --SCAT

• Result Qualifiers describe the specific results associated with the topic variable in a Findings dataset. They answer the question raised by the topic variable. Result Qualifiers are --ORRES, --STRESC, and --STRESN.
• 结果修饰语 (Result Qualifiers) ：在发现类数据集中，用来描述与主题变量相关的特定的结果。它们回答了主题变量（Topic Variable）所要表达的问题。例如：ORRES，–STRESC和 –STRESN

• Synonym Qualifiers specify an alternative name for a particular variable in an observation. Examples include --MODIFY and --DECOD, which are equivalent terms for a --TRT or --TERM topic variable, --TEST and --LOINC which are equivalent terms for a --TESTCD.
• 同义词修饰语 (Synonym Qualifiers) ：指定了观测记录中某一特定变量的其他可用名称。例如：–MODIFY和–DECOD是主题变量–TRT或–TERM的同义词修饰语，–TEST和–LOINC则是–TESTCD的同义词修饰语

• Record Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Examples include --REASND, AESLIFE, and all other SAE flag variables in the AE domain; AGE, SEX, and RACE in the DM domain; and --BLFL,–POS, --LOC, --SPEC and --NAM in a Findings domain
• 记录修饰语 (Record Qualifiers) ：从记录水平（而不是变量水平）定义某一观测的附加属性。例如：–REASND，–AESLIFE以及不良事件域（AE）中所有其他严重不良事件（SAE）的标识变量；人口统计学域（DM）中的AGE，SEX和RACE变量；发现类域中的–BLFL，–POS，–LOC，–SPEC和–NAM

• Variable Qualifiers are used to further modify or describe a specific variable within an observation and are only meaningful in the context of the variable they qualify. Examples include --ORRESU, --ORNRHI, and --ORNRLO, all of which are Variable Qualifiers of --ORRES; and
–DOSU, which is a Variable Qualifier of --DOSE.
• 变量修饰语 (Variable Qualifiers):用来进一步修饰和描述某一观测的特定变量，只能结合它所修饰的变量使用才有意义。例如：–ORRESU，–ORNRHI和–ORNRLO都是–ORRES的变量修饰语； --DOSU是–DOSE的变量修饰语。

For example, in the observation, “Subject 101 had mild nausea
starting on Study Day 6, “ the Topic variable value is the term for the adverse event, “NAUSEA”. The Identifier variable is the subject identifier, “101”. The Timing variable is the study day of the start of the event, which captures the information, “starting on Study Day 6”, while an example of a Record Qualifier is the severity, the value for which is “MILD”. Additional Timing and Qualifier variables could be included to provide the necessary detail to adequately describe an observation.
例如，对“受试者101在研究的第六天开始出现轻度恶心症状”这一观测记录，其主题变量值是不良事件术语“恶心”。标识符变量则是该受试者编号“101” 。时间变量值是该不良事件出现时研究已开始的天数， “开始于研究第6天”。该事件严重程度可视为记录修饰语的示例，其值为“轻度”，其他时间和修饰变量可视情况加入，以提供必要的细节来对观测记录进行充分的描述。

2.2 Datasets and Domains数据集和域

Observations about study subjects are normally collected for all
subjects in a series of domains. A domain is defined as a collection of
logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Each domain is represented by a single dataset. Each domain dataset is distinguished by a unique, two-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in four ways:

as the dataset name,

the value of the DOMAIN variable in that dataset,

as a prefix for most variable names in that dataset,

and as a value in the RDOMAIN variable in relationship tables [Section8 - Representing Relationships and Data].
通常情况下，所有研究受试者的观测数据都会收录到一系列不同的域中。域（Domain）是一组具有共同主题并且逻辑相关的观测结果的集合。其内在关系逻辑可能基于数据的科学属性或者与其在试验中的角色。每个域通过对应的数据集进行呈现。

每个域都由两个英文字母组成的代码进行区别，该代码在整个数据递交过程中要保持始终一致。域代码储存在SDTM标准变量DOMAIN中，有以下四种应用方式：

• 作为数据集的名称；

• 作为数据集中变量DOMAIN的值；

• 作为数据集中大多数变量名的前缀；

• 作为关系型数据集中变量RDOMAIN的值（参见第8章）。

All datasets are structured as flat files with rows representing observations and columns representing variables. Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document