4.1.4 General Considerations: SDTM, SEND, and/or ADaM 一般注意事项：SDTM、SEND 和/或 ADaM

4.1.4.1 Variables in SDTM and SEND: Required, Expected, and Permissible SDTM 和 SEND 中的变量：必需、预期和允许

For the purposes of SDTM and SEND submissions, all required, expected, and permissible variables that were collected, plus any variables that are used to compute derivations, should be submitted

出于 SDTM 和 SEND 提交的目的，应提交收集的所有必需、预期和允许变量，以及用于计算派生的任何变量。

FDA recognizes that SDTM contains certain operationally derived variables that have standard derivations across all studies (e.g., --STDY, EPOCH). If the data needed to derive these variables are missing, then these variables cannot be derived and the values should be null. The following are examples of some of the permissible and expected variables in SDTM and SEND that should be included, if available:

FDA认识到SDTM包含某些操作派生的变量，这些变量在所有研究中都有标准推导（例如，--STDY，EPOCH）。如果缺少派生这些变量所需的数据，则无法派生这些变量，并且值应为 null。以下是 SDTM 和 SEND 中应包含的一些允许变量和预期变量（如果可用）的示例：

1. Clinical baseline flags (e.g., last non-missing value prior to first dose) for laboratory results, vital signs, ECG, pharmacokinetic concentrations, and microbiology results. Nonclinical baseline flags (e.g., last non-missing value prior to first dose in parallel design studies) for laboratory results, vital signs, and ECG results. Currently for SDTM and SEND, baseline flags should be submitted if the data were collected or can be derived.

实验室结果、生命体征、心电图、药代动力学浓度和微生物学结果的临床基线标志（例如，首次给药前的最后一个非缺失值）。实验室结果、生命体征和心电图结果的非临床基线标志（例如，在平行设计研究中首次给药前的最后一个非缺失值）。目前，对于 SDTM 和 SEND，如果收集了数据或可以派生数据，则应提交基线标志。

2. EPOCH designators in SDTM. Please follow CDISC guidance for terminology. The variable EPOCH should be included for clinical subject-level observation (e.g., adverse events, laboratory, concomitant medications, exposure, and vital signs). This will allow the reviewer to easily determine during which phase of the study the observation occurred (e.g., screening, on-therapy, follow-up), as well as the actual intervention the subject experienced during that phase.

SDTM 中的 EPOCH 指示符。请遵循 CDISC 术语指南。对于临床受试者水平的观察（例如，不良事件、实验室、伴随药物、暴露和生命体征），应包括可变 EPOCH。这将使评价员能够轻松确定观察结果发生在研究的哪个阶段（例如，筛查，治疗，随访），以及受试者在该阶段经历的实际干预。

3. Whenever --DTC, --STDTC or --ENDTC, which have the role of timing variables, are included in a general observation class domain, the matching study day variables (--DY, --STDY, or --ENDY, respectively) should be submitted. For example, in most findings domains, --DTC is expected, which means that --DY should also be submitted. In the SDTM subject visits domain, SVSTDTC is required and SVENDTC is expected; therefore, both SVSTDY and SVENDY should be submitted.

每当具有时序变量作用的 --DTC、--STDTC 或 --ENDTC 包含在一般观测类域中时，应提交匹配的研究日变量（分别为 --DY、--STDY 或 --ENDY）。例如，在大多数发现域中，--DTC是预期的，这意味着--DY也应该提交。在SDTM受试者访问领域，SVSTDTC是必需的，SVENDTC是预期的;因此，应同时提交 SVSTDY 和 SVENDY。

As mentioned in section 4.1.3.3, in certain GLP nonclinical studies submitted in SEND, PCDTC and PCDY may be imputed.

如第4.1.3.3节所述，在SEND中提交的某些GLP非临床研究中，PCDTC和PCDY可能会被归因。

4.1.4.2 Dates in SDTM and SEND SDTM 和 SEND 域中的日期

Dates in SDTM and SEND domains should conform to the ISO 8601 format. Examples of how to implement dates are included in the SDTMIGs and SENDIGs

SDTM 和 SEND 域中的日期应符合 ISO 8601 格式。如何实现日期的示例包含在 SDTMIG 和 SENDIG 中

4.1.4.3 Naming Conventions in SDTM and SEND( SDTMIG 和 SENDIG 中指定的命名约定)

Naming conventions (variable name and label) and variable formats should be followed as specified in the SDTMIGs and SENDIGs.

应遵循 SDTMIG 和 SENDIG 中指定的命名约定（变量名称和标签）和变量格式。

4.1.4.4 SDTM and SEND Versions SDTM and SEND版本

When submitting clinical or nonclinical data, sponsors should not mix versions within a study. As noted above, the Catalog lists the versions that are supported by FDA.

在提交临床或非临床数据时，申办方不应在研究中混合使用。如上所述，该目录列出了FDA支持的版本。

4.1.4.5 Data Definition Files for SDTM, SEND, and ADaM （SDTM, SEND, and ADaM的数据说明文件）[译注：即define.xml]

The data definition file describes the metadata of the submitted electronic datasets, and is considered arguably the most important part of the electronic dataset submission for regulatory review. This data definition specification for submitted datasets defines the metadata structures that should be used to describe the datasets, variables, possible values of variables when appropriate, and controlled terminologies and codes. An insufficiently documented data definition file is a common deficiency that reviewers have noted. Consequently, the sponsor needs to provide complete detail in this file, especially for the specifications pertaining to derived variables. In addition, sponsors should also make certain that the code list and origin for each variable are clearly and easily accessible from the data definition file. The version of any external dictionary should be clearly stated both in the data definition file and in the full TS domain when it is submitted. The internal dataset label should also clearly describe the contents of the dataset. For example, the dataset label for an efficacy dataset might be ‘Time to Relapse (Efficacy).’

数据定义文件描述了所提交的电子数据集的元数据，并且可以说是提交电子数据集以供监管审查的最重要部分。此提交数据集的数据定义规范定义了应用于描述数据集、变量、变量的可能值（如果适用）以及受控术语和代码的元数据结构。记录不充分的数据定义文件是审稿人注意到的常见缺陷。因此，发起人需要在此文件中提供完整的详细信息，特别是对于与派生变量相关的规范。此外，发起人还应确保每个变量的代码列表和原点都可以从数据定义文件中清晰易行地访问。提交时，任何外部字典的版本都应在数据定义文件和完整的 TS 域中明确说明。内部数据集标签还应清楚地描述数据集的内容。例如，功效数据集的数据集标签可能是“复发时间（疗效）”。

Separate data definition files should be included for each type of electronic dataset submission, i.e., a separate data definition file for the SDTM datasets of a given clinical study, a separate data definition file for the SEND datasets of a given nonclinical study, and a separate data definition file for the ADaM datasets of a given clinical study. The data definition file should be submitted in XML format, i.e., a properly functioning define.xml. In addition to the define.xml, a printable define.pdf should be provided if the define.xml cannot be printed. To confirm that a define.xml is printable within the CDER IT environment, it is recommended that the sponsor submit a test version to cder-edata@fda.hhs.gov prior to application submission. The Catalog lists the currently supported version(s) of define.xml. It should be noted that define.xml version 2.0 is the preferred version. Sponsors should include a reference to the style sheet as defined in the specification (as listed in the Catalog) and place the corresponding style sheet in the same submission folder as the define.xml file. Within the eCTD study tagging file (STF), valid file-tags for define.xml are ‘data-tabulation-data-definition’ for SEND or SDTM datasets or ‘analysis-data-definition’ for ADaM datasets.

每种类型的电子数据集提交都应包含单独的数据定义文件，即给定临床研究的SDTM数据集的单独数据定义文件，给定非临床研究的SEND数据集的单独数据定义文件，以及给定临床研究的ADaM数据集的单独数据定义文件。数据定义文件应以XML格式提交，即功能正常的define.xml。除了define.xml之外，如果无法打印define.xml，还应提供可打印的define.pdf。为了确认define.xml在CDER IT环境中是可打印的，建议申办方在提交申请之前向 cder-edata@fda.hhs.gov 提交测试版本。目录列出了define.xml当前支持的版本。应该注意的是，定义.xml 2.0 版是首选版本。发起人应包括对规范中定义的样式表的引用（如目录中所列），并将相应的样式表放在与define.xml文件相同的提交文件夹中。在eCTD研究标记文件（STF）中，define.xml的有效文件标签是SEND或SDTM数据集的“数据制表数据定义”或ADaM数据集的“分析数据定义”。