Clinical Data Acquisition Standards Harmonization Model
临床数据采集标准协调模型
Version 1.0 版本 1.0
Prepared by the 准备由CDISC CDASH Team CDISC CDASH 团队
Notes to Readers 读者须知
This is Version 1.0 of the Clinical Data Acquisition Standards Harmonization Model.
这是临床数据采集标准协调模型的版本 1.0。
Revision History 修订历史
| Date 日期 | Version 版本 |
|---|---|
| 2017-09-20 | 1.0 Final 1.0 最终版 |
© 2017 Clinical Data Interchange Standards Consortium. All rights reserved. See also Representations and Warranties, Limitations of Liability, and Disclaimers.
© 2017 临床数据交换标准联盟。保留所有权利。另请参见陈述和保证、责任限制及免责声明。
1 Introduction 1 引言
The Clinical Data Acquisition Standards Harmonization (CDASH) Model describes the foundational structure for the organization, naming, and description of variable and associated attributes to support data collection in clinical trials. The CDASH Model provides naming conventions for the CDASH Implementation Guide (CDASHIG) variables along with additional metadata to help facilitate mapping collected data to their respective SDTM Implementation Guide (SDTMIG) variables.
临床数据采集标准协调（CDASH）模型描述了组织、命名和描述变量及其相关属性的基础结构，以支持临床试验中的数据收集。CDASH 模型为 CDASH 实施指南（CDASHIG）变量提供了命名约定，并附加了元数据，以帮助将收集的数据映射到相应的 SDTM 实施指南（SDTMIG）变量。
The CDASH Model aligns with and is structured similarly to the SDTM Model. The CDASH Model organizes data into classes, which represent meaningful groupings of data in clinical research. It defines CDASH metadata for identifier variables, timing variables, general observation class variables (Events, Interventions, and Findings), domain-specific variables, and special-purpose domain variables, (e.g., DM, CO).
CDASH 模型与 SDTM 模型一致，并且结构相似。CDASH 模型将数据组织成类别，这些类别代表临床研究中有意义的数据分组。它定义了 CDASH 元数据，包括标识符变量、时间变量、一般观察类别变量（事件、干预和发现）、特定领域变量以及特殊用途领域变量（例如，DM、CO）。
Sponsors may implement any CDASH variable defined by a Class within one of its respective CDASHIG domains. Any variable found in a data class in the CDASH Model may be implemented in any CDASHIG domain within that class. For example, the Interventions class variable --ROUTE, although not defined in the Substance Use (SU) domain, may be added to SU if needed. The domain-specific section of the CDASH Model defines variables that may not be reused across multiple Domains for a given Class.
赞助商可以在其各自的 CDASHIG 领域内实施由某个类别定义的任何 CDASH 变量。CDASH 模型中数据类中的任何变量都可以在该类的任何 CDASHIG 领域中实施。例如，干预类变量 -- ROUTE，尽管未在物质使用 (SU) 领域中定义，但如果需要，可以添加到 SU 中。CDASH 模型的领域特定部分定义了在给定类别中可能无法在多个领域之间重用的变量。
Similar to the SDTM Model and SDTMIG, not all CDASH Model variables are replicated in each CDASHIG domain. Commonly used CDASH Model variables are included within their respective CDASHIG Domains.
与 SDTM 模型和 SDTMIG 类似，并非所有 CDASH 模型变量都在每个 CDASHIG 领域中复制。常用的 CDASH 模型变量包含在各自的 CDASHIG 领域中。
Attributes defined for each Model variable are: Class, Name, Label, Question Text, Prompt, Data Type, SDTM Target, SDTM Mapping Instructions, Definition, Controlled Terminology Codelist Name, and Implementation Notes.
每个模型变量定义的属性包括：类别、名称、标签、问题文本、提示、数据类型、SDTM 目标、SDTM 映射说明、定义、受控术语代码列表名称和实施说明。
Reference the CDASHIG for more information about using this Model to implement each of the domain classes (including Findings About) and creating custom domains.
参考 CDASHIG 以获取有关使用此模型实现每个领域类（包括发现相关）和创建自定义领域的更多信息。
2 The CDASH Model 2 CDASH 模型
2.1 Interventions 2.1 干预措施
Interventions 干预措施
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Interventions 干预措施 | N/A | 1 | --YN | Any [Intervention] 任何[干预] | An indication whether or not any data was collected for the intervention topic. 是否收集了干预主题的任何数据的指示。 | Has the subject had any [intervention topic(s)] (after/before) [study-specific time frame] (after/before [study-specific time frame] )?; [Was/Were] (there) any [intervention topic(s)] [taken/performed/used/collected] (after/before ) study-specific time frame])? 受试者在[研究特定时间范围]（之前/之后）是否有过任何[干预主题]？[是否有]在研究特定时间范围（之前/之后）[进行/使用/收集]任何[干预主题]？ | Any [Intervention Topic] 任何[干预主题] | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | General prompt question to aid in monitoring and data cleaning. This provides verification that all other fields on the CRF were deliberately left blank. This is a field that can be used on any interventions CRF to indicate whether or not there is data to record. 一般提示问题，用于监测和数据清理。这提供了验证，确保 CRF 上的所有其他字段都是故意留空的。该字段可以在任何干预 CRF 上使用，以指示是否有数据需要记录。 |
| Interventions 干预措施 | N/A | 2 | --TRT | Name of Treatment 治疗名称 | The topic for the intervention observation, usually the reported name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation. 干预观察的主题通常是观察期间给药间隔内所报告的治疗、药物、药品或疗法的名称。 | What [is/was] the (type of) [treatment/intervention topic]?; [If other is selected], [explain/specify/provide more details] 该（类型的）[治疗/干预主题]是什么？; [如果选择了其他]，[请解释/说明/提供更多细节] | [Treatment/Intervention]; [Specify Other/ Explain/Specify Details [Treatment/Intervention] [治疗/干预]; [指定其他/解释/指定细节 [治疗/干预]] | Char 字符 | --TRT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | If --TRT is preprinted/pre-specified, the value should also be mapped into the --TRT variable. E.g., if Oral Steroid is preprinted on a CM CRF, "Oral Steroid" should be stored in CMTRT. The CDASH field --TRT can also be used to collect any free text values linked to the sponsor standardized value collected in the CDASH field --DECOD. For example, the CDASH field --DECOD may have a value of "OTHER" and the associated free text intervention topic is collected in the CDASH field --TRT. In this scenario, the Item prompt "Specify Other" may be used. 如果 --TRT 是预先打印/预先指定的，则该值也应映射到 --TRT 变量中。例如，如果口服类固醇在 CM CRF 上预先打印，则“口服类固醇”应存储在 CMTRT 中。CDASH 字段 --TRT 也可用于收集与 CDASH 字段 --DECOD 中收集的赞助商标准化值相关的任何自由文本值。例如，CDASH 字段 --DECOD 的值可能为“其他”，相关的自由文本干预主题则收集在 CDASH 字段 --TRT 中。在这种情况下，可以使用项目提示“指定其他”。 |
| Interventions 干预措施 | N/A | 3 | --DECOD | Dictionary or Standardized Term 字典或标准术语 | The dictionary or sponsor-defined standardized text description of the topic variable, --TRT, or the modified topic variable (-- MODIFY), if applicable. 主题变量的字典或赞助商定义的标准化文本描述，--TRT，或修改后的主题变量（--MODIFY），如适用。 | What [is/ was] the [treatment/ intervention topic] ? 治疗主题是什么？ | [Intervention Topic] [干预主题] | Char 字符 | --DECOD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | When populated by a coding dictionary (e.g., WHO Drug or MedDRA), Question Text and Prompt are not applicable. WHO Drug may be used for coding treatment names and MedDRA may be used for coding procedures. When these dictionaries are used, --DECOD is equivalent to those dictionaries' Preferred Term. The CDASH field --DECOD may be used to collect standardized pre-specified values (CDISC Controlled Terminology or sponsor-defined) on a CRF. The CDASH field --TRT can be used to collect any free text values linked to the sponsor standardized value. For example, the CDASH field --DECOD may have a value of "OTHER" and the associated free text intervention topic is collected in CDASH field --TRT. 当由编码字典（例如，WHO 药物或 MedDRA）填充时，问题文本和提示不适用。WHO 药物可用于编码治疗名称，MedDRA 可用于编码程序。当使用这些字典时，--DECOD 等同于这些字典的首选术语。CDASH 字段--DECOD 可用于在 CRF 上收集标准化的预先指定值（CDISC 控制术语或赞助商定义）。CDASH 字段--TRT 可用于收集与赞助商标准化值相关的任何自由文本值。例如，CDASH 字段--DECOD 的值可能为“其他”，相关的自由文本干预主题则收集在 CDASH 字段--TRT 中。 |
| Interventions 干预措施 | N/A | 4 | --MOOD | Mood 情绪 | The mode or condition of the record that specifies whether the intervention (activity) is intended to happen or has happened. 记录的模式或状态，指明干预（活动）是计划发生还是已经发生。 | Does this record describe scheduled treatment or performed treatment? 该记录是描述计划治疗还是已执行治疗？ | [Scheduled/Performed] [计划/执行] | Char 字符 | --MOOD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (BRDGMOOD) （BRDGMOOD） | "SCHEDULED" is used when collecting subject-level intended dose records. "PERFORMED" is used when collecting subject-level actual dose records. This would most commonly be a heading on the CRF and not a question to which the site would provide an answer. If collecting both the scheduled and performed dosing in the same horizontal record, the sponsor may append "_SCHEDULED" to the variable name to capture the scheduled dose. “计划”用于收集受试者级别的预期剂量记录。“实际”用于收集受试者级别的实际剂量记录。这通常是 CRF 上的一个标题，而不是现场需要回答的问题。如果在同一水平记录中收集计划和实际给药，赞助商可以在变量名称后附加“_SCHEDULED”以捕获计划剂量。 |
| Interventions 干预措施 | N/A | 5 | --CAT | Category 类别 | A grouping of topic-variable values based on user-defined characteristics. 基于用户定义特征的主题变量值分组。 | What [is/was] the category (of the intervention])? 干预的类别是什么？ | [Category/ Category Value]; NULL [类别/类别值]; NULL | Char 字符 | --CAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "category" can be included as the column header. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. 赞助商定义的受控术语。这通常是在 CRF 或屏幕上的标题，而不是站点提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。如果提出问题，回答通常是赞助商定义的代码列表。如果表格布局为网格，则可以将“类别”等词作为列标题。示例在 CDASHIG 元数据表或 SDTMIG 中提供。 |
| Interventions 干预措施 | N/A | 6 | --SCAT | Subcategory 子类别 | A sub-division of the --CAT values based on user-defined characteristics. 基于用户定义特征的--CAT 值的子划分。 | What [is/was] the subcategory (of the [intervention])? 该[干预]的子类别是什么？ | [Subcategory/ Subcategory Value]; NULL [子类别/子类别值]; NULL | Char 字符 | --SCAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "subcategory" can be included as the column header. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. 赞助商定义的受控术语。这通常是在 CRF 或屏幕上的标题，而不是站点提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。如果提出问题，回答通常是赞助商定义的代码列表。如果表格以网格形式布局，则可以将“子类别”等词作为列标题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。 |
| Interventions 干预措施 | N/A | 7 | --PRESP | Pre-Specified Intervention 预先指定的干预 | An indication that a specific intervention or a group of interventions is pre-specified on a CRF. 在 CRF 上预先指定特定干预或一组干预的指示。 | N/A | N/A | Char 字符 | --PRESP | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | For pre-specified interventions, a hidden field on a CRF defaulted to Y, or added during the SDTM dataset creation. If a study collects both pre-specified interventions as well as free-text interventions, the value of --PRESP should be Y for all pre-specified interventions and null for interventions reported as free-text. 对于预先指定的干预措施，CRF 上的一个隐藏字段默认为 Y，或在 SDTM 数据集创建时添加。如果一项研究同时收集预先指定的干预措施和自由文本干预措施，则所有预先指定的干预措施的--PRESP 值应为 Y，而自由文本报告的干预措施的值应为 null。 |
| Interventions 干预措施 | N/A | 8 | --OCCUR | Occurrence 发生 | An indication that the pre-specified intervention happened or was administered when information about the occurrence of the specific intervention is solicited. 一个指示，表明在询问特定干预发生情况时，预先指定的干预已发生或已实施。 | Was [--TRT/ intervention] [taken/performed/administered/consumed] (after/before [study-specific time frame])?; Has the subject [had/taken/performed/administered/consumed] the [--TRT/ intervention]? 在[研究特定时间范围]（之前/之后）是否[进行了/施行了/给予了/消费了] [--TRT/干预]？受试者是否[进行了/施行了/给予了/消费了] [--TRT/干预]？ | [--TRT/ Intervention] [Had/Taken/Performed/Administered/Consumed] [--TRT/干预] [已/采取/执行/施用/消费] | Char 字符 | --OCCUR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | Used for specific interventions that are collected as defined by the protocol. If the term is preprinted/pre-specified, the value should also be mapped into the --TRT variable. E.g., if Oral Steroid is preprinted on a CM CRF, "Oral Steroid" should be stored in CMTRT. The CDASH field --OCCUR is not used for spontaneously free text reported --TRT. Should not be used to indicate data was not collected. Used only when the value can be collected using values from the CDISC CT (NY) codelist. --OCCUR is a Yes/No variable and in the SDTM submission datasets, --OCCUR is populated when --PRESP is "Y" and --OCCUR is null when --PRESP is null. 用于根据协议定义收集的特定干预。如果术语是预印刷/预先指定的，则该值也应映射到 --TRT 变量。例如，如果口服类固醇在 CM CRF 上预印刷，则“口服类固醇”应存储在 CMTRT 中。CDASH 字段 --OCCUR 不用于自发自由文本报告的 --TRT。不得用于指示数据未被收集。仅在可以使用 CDISC CT (NY) 代码表中的值收集该值时使用。--OCCUR 是一个是/否变量，在 SDTM 提交数据集中，当 --PRESP 为“Y”时，--OCCUR 被填充，当 --PRESP 为 null 时，--OCCUR 为 null。 |
| Interventions 干预措施 | N/A | 9 | --STAT | Completion Status 完成状态 | The variable used to indicate that data are not available by having the site recording the value as "Not Done". 用于指示数据不可用的变量，通过将站点记录的值设置为“未完成”来实现。 | Was the [intervention topic] not [answered/done/assessed/evaluated]?; Indicate if ([intervention topic] was) not [answered/assessed/done/evaluated]. [干预主题]是否没有[回答/完成/评估/评价]？; 指出是否([干预主题]没有) [回答/评估/完成/评价]。 | Not Done 未完成 | Char 字符 | --STAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". If collected, the Origin (column in the Define-XML) = "CRF", if populated from other sources such as a free text or sponsor-defined listing for --REASND, the Origin ="DERIVED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。如果收集，则来源（Define-XML 中的列）= "CRF"；如果从其他来源填充，例如自由文本或赞助商定义的--REASND 列表，则来源="DERIVED"。 | (ND) | The value of "Not Done" indicates the data are not available or the question was not asked. Do not use this CDASH field when information on whether or not a pre-specified intervention was performed is collected as this should be collected using the CDASH field --OCCUR. “未完成”的值表示数据不可用或未询问该问题。当收集是否进行了预先指定的干预的信息时，请勿使用此 CDASH 字段，因为应使用 CDASH 字段--OCCUR 进行收集。 |
| Interventions 干预措施 | N/A | 10 | --CSTAT | Collected Completion Status 收集的完成状态 | The variable used to indicate that data are not available by having the site recording a sponsor-defined value (e.g., Not Collected/Not Evaluated/Not Assessed/Not Available/Not Answered) 用于指示数据不可用的变量，通过让站点记录赞助商定义的值（例如：未收集/未评估/未评定/不可用/未回答） | Was the [intervention topic] not [collected/answered/done/assessed/evaluated/available]?; Indicate if ( [intervention topic] was) not [collected/answered/ assessed/ done/evaluated/available]. [干预主题]是否未[收集/回答/完成/评估/评价/可用]？; 指出是否([干预主题]未)[收集/回答/评估/完成/评价/可用]。 | Not Collected 未收集 | Char 字符 | --STAT | This does not map directly to an SDTM variable. For the SDTM dataset, the SDTM variable --STAT is populated by mapping the value of the CDASH variable CSTAT "NOT COLLECTED" to "NOT DONE". If collected, the Origin (column in the Define-XML)="CRF", if populated from other sources such as a free text or sponsor-defined listing for --REASND, the Origin ="DERIVED". 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，SDTM 变量--STAT 通过将 CDASH 变量 CSTAT 的值“未收集”映射为“未完成”来填充。如果已收集，来源（Define-XML 中的列）=“CRF”；如果是从其他来源填充，例如自由文本或赞助商定义的--REASND 列表，则来源=“派生”。 | N/A | A "Not Collected" check/tick box, which indicates the data/specimen was not collected. Typically, there would be one check box for each pre-specified intervention. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank. Do not use this CDASH field when information on whether or not an intervention was performed is collected as this typically would be collected using the CDASH field --OCCUR. “未收集”复选框，表示数据/样本未被收集。通常，每个预先指定的干预措施会有一个复选框。当询问多个问题以确认空结果字段确实是空时，此字段可能会很有用。当收集干预是否执行的信息时，请勿使用此 CDASH 字段，因为这通常会通过 CDASH 字段--OCCUR 进行收集。 |
| Interventions 干预措施 | N/A | 11 | --REASND | Reason Not Done 原因未完成 | An explanation of why the data are not available. 数据不可用的原因说明。 | Was the [is/was] the reason that the [intervention topic/data/information/sponsor-defined phrase] was not [collected/answered/done/assessed/evaluated]? 这是否是[干预主题/数据/信息/赞助商定义的短语]未被[收集/回答/完成/评估/评价]的原因？ | Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available] 原因未[回答/收集/完成/评估/评定/可用] | Char 字符 | --REASND | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology may be used. The reason the data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused, etc.) or entered as free text. When --REASND is used, --STAT should also be populated in the SDTM dataset. 赞助商定义的受控术语可以使用。数据不可用的原因可以从赞助商定义的代码列表中选择（例如，设备故障、受试者拒绝等）或作为自由文本输入。当使用--REASND 时，--STAT 也应在 SDTM 数据集中填充。 |
| Interventions 干预措施 | N/A | 12 | --INDC | Indication 指示 | The condition, disease, symptom or disorder that the intervention was used to address or investigate (e.g., why the therapy was taken or administered or the procedure performed). 干预用于解决或调查的情况、疾病、症状或障碍（例如，为什么进行治疗或施用治疗或执行该程序）。 | For what indication was the [--TRT] [taken/performed/administered/consumed]? 该[--TRT]是出于什么指征而[进行/施用/服用]的？ | Indication 指示 | Char 字符 | --INDC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This additional information is collected on the CRF when the sponsor wants to capture the indication(s)/medical problem(s) why a subject took/had an intervention. This information can then be used as deemed appropriate for coding, analysis, or for reconciling the interventions as part of the data clean-up and monitoring process, etc. 此附加信息在 CRF 上收集，当赞助商希望记录受试者接受干预的指示/医疗问题时。然后可以根据需要将此信息用于编码、分析或作为数据清理和监测过程的一部分来核对干预等。 |
| Interventions 干预措施 | N/A | 13 | --DOSE | Dose 剂量 | The amount of substance (e.g. --TRT ) given at one time represented as a numeric value. 一次给定的物质量（例如 --TRT）以数值形式表示。 | What [is/ was] the (individual) [dose/amount] (of [--TRT] [taken/performed/administered/consumed/per administration])? 个体的[剂量/数量]（[--TRT]的[服用/执行/施用/消费/每次给药]）是什么？ | [Dose/Amount] (per administration) [剂量/数量]（每次给药） | Num 数字 | --DOSE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Used when the dose/amount taken/administered/consumed has only numeric entries. If non-numeric entries are possible, use the CDASH field --DSTXT. 仅在剂量/数量的取用/给药/消费只有数字条目时使用。如果可能有非数字条目，请使用 CDASH 字段--DSTXT。 |
| Interventions 干预措施 | N/A | 14 | --DSTXT | Dose Description 剂量描述 | The amount of substance ( e.g., --TRT) given at one time represented in text format. 一次给定的物质量（例如，--TRT）以文本格式表示。 | What [is/ was] the (individual) [dose/amount] (of [--TRT] [taken/performed/administered/consumed/per administration])? 个体的[剂量/数量]（[--TRT]的[服用/执行/施用/消费/每次给药]）是什么？ | [Dose/Amount] (per administration) [剂量/数量]（每次给药） | Char 字符 | --DOSE; --DOSTXT --剂量; --剂量文本 | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text or ranges. 将此数据收集字段定义为剂量文本字段，可以灵活地以数字、文本或范围的形式捕获剂量条目。 |
| Interventions 干预措施 | N/A | 15 | --DOSU | Dose Unit 剂量单位 | The unit for --DOSE, --DOSTOT, or --DOSTXT. --DOSE、--DOSTOT 或 --DOSTXT 的单位。 | What [is/was] the unit (for the dose/amount of [--TRT])? [--TRT]的剂量/数量单位是什么？ | ([Dose/Amount]) Unit （[剂量/数量]）单位 | Char 字符 | --DOSU | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (UNIT) （单位） | When possible, is pre-printed on the CRF with the associated treatment. Dose unit may be derived via other methods (e.g., derived from protocol, data). When collected, the unit is pre-printed on the CRF or a field provided on the CRF to capture it. 在可能的情况下，相关治疗的剂量单位会预先印刷在 CRF 上。剂量单位可以通过其他方法获得（例如，从方案或数据中得出）。收集时，单位会预先印刷在 CRF 上或在 CRF 上提供的字段中进行捕获。 |
| Interventions 干预措施 | N/A | 16 | --DOSFRM | Dose Form 剂型 | The form in which the --TRT is physically presented. --TRT 以何种形式在物理上呈现。 | What[is/ was] the dose form (of the [--TRT] )? [--TRT] 的剂型是什么？ | Dose Form 剂型 | Char 字符 | --DOSFRM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (FRM) | N/A |
| Interventions 干预措施 | N/A | 17 | --DOSFRQ | Dosing Frequency per Interval 每个间隔的给药频率 | The number of doses given/administered/taken during a specific interval. 在特定时间间隔内给予/施用/服用的剂量数量。 | What [is/ was] the frequency (of the [--TRT] )? [--TRT] 的频率是多少？ | Frequency 频率 | Char 字符 | --DOSFRQ | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (FREQ) | When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., --DOSE ,--DOSEU,--DOSFRQ) for specific and consistent data collection and to enable programmatically utilizing these data. 在可能的情况下，剂量/数量频率的选项会预先打印在 CRF 上。收集时，建议在单独的字段中收集剂量信息（例如，--DOSE，--DOSEU，--DOSFRQ），以便进行特定和一致的数据收集，并能够以编程方式利用这些数据。 |
| Interventions 干预措施 | N/A | 18 | --DOSTOT | Total Daily Dose 每日总剂量 | The total amount of --TRT taken over a day using the units in --DOSU. 每日使用--DOSU 单位的--TRT 总量。 | What [is/was] the total [dose/amount] (of the [--TRT/Intervention] [taken/performed/administered/consumed])? 总剂量是多少（已采取/执行/施用/消耗的[--TRT/干预]）？ | Total Daily [Dose/Amount] 每日总剂量/数量 | Num 数字 | --DOSTOT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Used when dosing is collected as Total Daily Dose. 用于收集总每日剂量时。 |
| Interventions 干预措施 | N/A | 19 | --DOSRGM | Intended Dose Regimen 预期剂量方案 | The text description of the intended dosing schedule for the administration of the Intervention. 干预措施给药计划的文本描述。 | What [is/ was] the intended dose regimen (of the [--TRT] )? 预定的剂量方案（[--TRT]）是什么？ | Intended Dose Regimen 预期剂量方案 | Char 字符 | --DOSRGM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | When possible, the options for intended dose regimen are pre-printed on the CRF. The sponsor may wish to create a codelist to collect this data consistently. Example: TWO WEEKS ON, TWO WEEKS OFF. 在可能的情况下，预期剂量方案的选项会预先打印在 CRF 上。赞助商可能希望创建一个代码列表，以一致地收集这些数据。示例：两周用药，两周停药。 |
| Interventions 干预措施 | N/A | 20 | --ROUTE | Route of Administration 给药途径 | The route of administration of the intervention. 干预的给药途径。 | What [is/ was] the route of administration (of the [--TRT] )? [--TRT] 的给药途径是什么？ | Route 路线 | Char 字符 | --ROUTE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (ROUTE) （路线） | N/A |
| Interventions 干预措施 | N/A | 21 | --LOC | Location 位置 | The anatomical location of an intervention, such as an injection site. 干预的解剖位置，例如注射部位。 | What [is/was] the anatomical location (of the administration/where the [intervention] was taken/performed)? 施治的解剖位置在哪里？ | Anatomical Location 解剖位置 | Char 字符 | --LOC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LOC) (地点) | This may be pre-printed or collected. --LOC is used only to specify the anatomical location. --LAT, --DIR, --PORTOT are used to further describe the anatomical location. 这可以是预先打印的或收集的。--LOC 仅用于指定解剖位置。--LAT、--DIR、--PORTOT 用于进一步描述解剖位置。 |
| Interventions 干预措施 | N/A | 22 | --LAT | Laterality 侧向性 | Qualifier for anatomical location further detailing side of intervention administration. 干预施行侧的解剖位置进一步细化的限定词。 | What [is/was] the side (of the anatomical location of the administration)? 给药的解剖位置是哪个侧面？ | Side 侧面 | Char 字符 | --LAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LAT) | Further detailing the laterality of the location where the --TRT was administered/taken. This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF. 进一步详细说明--TRT 施用/服用位置的侧向性。这可以是预先打印的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Interventions 干预措施 | N/A | 23 | --DIR | Directionality 方向性 | Qualifier further detailing the position of the anatomical location relative to the center of the body, organ, or specimen. 进一步说明解剖位置相对于身体、器官或标本中心的定性描述。 | What [is/was] the directionality (of the anatomical location of the administration)? 给药的解剖位置的方向性是什么？ | Directionality 方向性 | Char 字符 | --DIR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (DIR) | Further detailing the directionality of the location where the --TRT was administered/taken (e.g., ANTERIOR, LOWER, PROXIMAL). This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF. 进一步详细说明--TRT 施用/服用位置的方向性（例如，前部、下部、近端）。这可以是预先打印的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Interventions 干预措施 | N/A | 24 | --PORTOT | Portion or Totality 部分或整体 | Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. 解剖位置的限定词进一步详细说明了分布，这意味着排列和分配。 | What [is/was] the portion or totality (of the anatomical location of the administration)? 给药的解剖位置的部分或整体是什么？ | Portion or Totality 部分或整体 | Char 字符 | --PORTOT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (PORTOT) （波尔图） | Further detailing the portion or totality of the location where the --TRT was administered/taken. This may be pre-printed or collected. 进一步详细说明--TRT 施用/服用的地点部分或整体。这可以是预先打印的或收集的。 |
| Interventions 干预措施 | N/A | 25 | --FAST | Fasting Status 禁食状态 | An indication that the subject has abstained from food/water for the specified amount of time. 表明受试者在指定时间内已禁食/禁水。 | [Is/ Was ] the subject fasting (prior to study treatment being taken/administered/given]) ? 受试者在接受研究治疗之前是否禁食？ | Fasting 禁食 | Char 字符 | --FAST | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | N/A |
| Interventions 干预措施 | N/A | 26 | --PSTRG | Pharmaceutical Strength 药品强度 | The amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. 每剂量单位、每体积单位或每重量单位中按药物剂型定量表示的活性成分的数量。 | What [is/was] the pharmaceutical strength (of the [--TRT])? 该[--TRT]的药物强度是多少？ | Pharmaceutical Strength 药品强度 | Num 数字 | --PSTRG | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Interventions 干预措施 | N/A | 27 | --PSTRGU | Pharmaceutical Strength Unit 药品强度单位 | The unit for --PSTRG. --PSTRG 的单位。 | What [is/was] the unit (of the pharmaceutical strength (of the [--TRT])? 药物强度的单位是什么（或曾经是什么）？ | Unit 单位 | Char 字符 | --PSTRGU | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (UNIT) （单位） | The unit is pre-printed on the CRF or a field provided on the CRF to capture it. 该单位已预先打印在 CRF 上，或在 CRF 上提供的字段中以捕获它。 |
| Interventions 干预措施 | N/A | 28 | --TRTV | Treatment Vehicle 治疗车辆 | The vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. 用于治疗的载体，例如溶解治疗药物的液体。 | What [is/was] the vehicle for administration of the [--TRT]? [--TRT]的管理工具是什么？ | Treatment Vehicle 治疗车辆 | Char 字符 | --TRTV | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Interventions 干预措施 | N/A | 29 | --VAMT | Treatment Vehicle Amount 治疗车辆数量 | The amount of the prepared product (treatment + vehicle) administered or given. 所给药物（治疗剂 + 载体）的制备产品量。 | What [ is/ was] the amount (of the prepared product (treatment + vehicle)) [administered/taken]) ? 所给药（处理+载体）制备产品的数量是多少？ | Treatment + Vehicle Amount 治疗 + 车辆数量 | Char 字符 | --VAMT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Note: should not be diluent amount alone. 注意：不应仅考虑稀释剂的量。 |
| Interventions 干预措施 | N/A | 30 | --VAMTU | Treatment Vehicle Amount Unit 治疗车辆数量单位 | The unit of measurement for the prepared product (treatment + vehicle). 制备产品（处理剂 + 载体）的计量单位。 | What [is/was] the unit ? 单位是什么？ | Unit 单位 | Char 字符 | --VAMTU | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (UNIT) （单位） | The unit is pre-printed on the CRF or a field provided on the CRF to capture it. 该单位已预先打印在 CRF 上，或在 CRF 上提供的字段中以捕获它。 |
| Interventions 干预措施 | N/A | 31 | --FLRT | [ --TRT] Infusion Rate 输注速率 | The flow rate for the total amount of drug + vehicle administered to the subject. 给受试者施用的药物和载体的总流量。 | What [is/was] the ([--TRT ]infusion) rate? 输注速率是多少？ | ([ --TRT] Infusion ) Rate （[ --TRT] 输注）速率 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "-- FLRT" and SUPP--.QLABEL = "Infusion Rate". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "-- FLRT"且 SUPP--.QLABEL = "输注速率"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | N/A | Infusion rate can be used to derive dose. 输注速率可以用来推导剂量。 |
| Interventions 干预措施 | N/A | 32 | --FLRTU | [--TRT] Infusion Rate Unit 输注速率单位 | The unit of measure for the flow rate for the total amount of drug + vehicle administered to the subject. 给受试者施用的药物和载体总量的流量单位。 | What [is/was] the ([--TRT] infusion rate) unit? 什么是（[--TRT] 输注速率）单位？ | ([--TRT] infusion Rate) Unit （[--TRT] 输注速率）单位 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM= "--FLRTU" and SUPP.QLABEL= "Infusion Rate Unit". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM= "--FLRTU" 和 SUPP.QLABEL= "输注速率单位"。有关在 SDTM 域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | (UNIT) （单位） | The infusion rate unit (e.g., mL/min) is pre-printed on the CRF or a field provided on the CRF to capture it. 输注速率单位（例如，mL/min）已预先打印在 CRF 上，或在 CRF 上提供了一个字段以记录该信息。 |
| Interventions 干预措施 | N/A | 33 | --ADJ | Reason for Dose Adjustment 剂量调整的原因 | Description or explanation of why a dose/amount of the intervention is adjusted. 调整干预剂量/数量的原因或解释。 | What [is/was] the reason the (study treatment/procedure) [dose/amount] was adjusted? 调整（研究治疗/程序）[剂量/数量]的原因是什么？ | Reason Adjusted 理由调整 | Char 字符 | --ADJ | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | The implementer may choose to create sponsor-defined controlled terminology such as, Adverse Event, Insufficient response, Non-Medical Reason, etc. 实施者可以选择创建赞助方定义的受控术语，例如不良事件、反应不足、非医疗原因等。 |
| Interventions 干预措施 | N/A | 34 | --DOSADJ | Dose Adjusted 剂量调整 | An indication whether or not the dose was adjusted. 是否调整了剂量的指示。 | [Is/Was] the (study treatment/procedure) [dose/amount] adjusted? [研究治疗/程序]的[剂量/数量]是否进行了调整？ | (Dose) Adjusted （剂量）调整 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. If the Reason for Dose Adjustment is not collected, the sponsor might chose to submit this as a supplemental qualifier. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。如果未收集剂量调整的原因，赞助商可能会选择将其作为补充限定符提交。 | (NY) （纽约） | Typically, the intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the associate field on the CRF was deliberately left blank. However, the sponsor may collect whether the intervention was adjusted, without collecting the reason for the change. 通常，收集此字段的意图/目的在于帮助数据清理和监控。它提供了对 CRF 上关联字段故意留空的验证。然而，赞助方可能会收集干预是否被调整的信息，而不收集更改的原因。 |
| Interventions 干预措施 | N/A | 35 | --ITRPYN | Intervention Interrupted 干预中断 | An indication whether of not the intervention was interrupted. 干预是否被中断的指示。 | [Is/Was] the [--TRT/Intervention] interrupted? [干预]是否被中断？ | [--TRT/Intervention] Interrupted [--TRT/干预] 中断 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring when the actual duration of the interruption is collected using the CDASH field --ITRPDU. In some situations, if the actual duration of the interruption is not collected, or not derived, this information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--ITRPYN" and SUPP--.QLABEL = "Intervention Interrupted". 收集此字段的意图/目的在于帮助数据清理和监测，当实际中断持续时间通过 CDASH 字段--ITRPDU 收集时。在某些情况下，如果未收集实际中断持续时间或未推导出该信息，则可以在 SUPP--.QVAL 数据集中提交此信息，其中 SUPP--.QNAM = "--ITRPYN"和 SUPP--.QLABEL = "干预中断"。 |
| Interventions 干预措施 | N/A | 36 | --REASOC | Reason for Occur Value 发生值的原因 | An explanation of why a scheduled intervention did not occur. 未能按计划进行干预的原因说明。 | What was the reason that the [intervention topic] was not [performed/taken/done/administered]? 为什么[干预主题]没有[进行/采取/完成/施行]？ | Reason Not [Performed/Taken/Done/Administered 未执行/未采取/未完成/未施行 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--REASOC" and SUPP--.QLABEL ="Reason for Occur Value". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--REASOC"和 SUPP--.QLABEL = "发生值的原因"。有关在 SDTM 域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | N/A | The reason the intervention did not occur may be chosen from a sponsor-defined codelist (e.g., SUBJECT MISTAKE, SUBJECT REFUSED, etc.) or entered as free text. When --REASOC is used, --OCCUR must also be populated in the SDTM dataset with a value of "N". 干预未发生的原因可以从赞助商定义的代码列表中选择（例如，受试者错误、受试者拒绝等）或作为自由文本输入。当使用--REASOC 时，--OCCUR 也必须在 SDTM 数据集中填入值为"N"。 |
| Interventions 干预措施 | N/A | 37 | --ITRPRS | Reason Intervention Interrupted 原因干预中断 | An indication why the intervention was interrupted. 干预中断的原因指示。 | Why was the [--TRT/Intervention] interrupted? 为什么[--TRT/干预]被中断了？ | Reason [--TRT/Intervention] Interrupted 原因 [--TRT/干预] 中断 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ITRPRS" and SUPP--.QLABEL ="Reason Intervention Interrupted". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ITRPRS"且 SUPP--.QLABEL = "干预中断原因"。有关在 SDTM 域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | N/A | This CDASH field is use to collected the reason why an intervention was interrupted. The sponsor may define their own controlled terminology. 该 CDASH 字段用于收集干预中断的原因。赞助商可以定义自己的受控术语。 |
| Interventions 干预措施 | N/A | 38 | --ITRPD | Interruption Duration 中断持续时间 | The duration of the intervention interruption as collected. 干预中断的持续时间已收集。 | What was the duration of the [--TRT/Intervention] interruption?; How long was the [--TRT/Intervention] interruption? [--TRT/干预]中断持续了多长时间？; [--TRT/干预]中断持续了多久？ | Interruption Duration 中断持续时间 | Char 字符 | SUPP--.QVAL | Concatenate the CDASH fields for the interruption duration and the unit components and create --ITRPD using ISO 8601 Period format. The information could be submitted in an SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ITRPD" and SUPP--.QLABEL = "Interruption Duration". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 将 CDASH 字段连接起来，形成中断持续时间和单位组件，并使用 ISO 8601 期间格式创建--ITRPD。该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ITRPD"且 SUPP--.QLABEL = "中断持续时间"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | N/A | This CDASH field is use to collected the duration of an intervention interruption. In some situations, the duration of the interruption may not be collected but calculated from the procedure start and end times recorded elsewhere in the CRF. This derived duration is not included in an SDTM dataset. 该 CDASH 字段用于收集干预中断的持续时间。在某些情况下，中断的持续时间可能不会被收集，而是从 CRF 中其他地方记录的程序开始和结束时间计算得出。该派生的持续时间不包括在 SDTM 数据集中。 |
| Interventions 干预措施 | N/A | 39 | --ITRPDU | Interruption Duration Unit 中断持续时间单位 | The unit for the duration of the intervention interruption. 干预中断持续时间的单位。 | What [is/was] the (interruption duration) unit? 中断持续时间的单位是什么？ | Unit 单位 | Char 字符 | SUPP--.QVAL | Concatenate the CDASH fields for the interruption duration and the unit components and create --ITRPDU using ISO 8601 Period format. The information could be submitted in an SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ITRPDU" and SUPP--.QLABEL = "Interruption Duration". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 将 CDASH 字段连接起来，形成中断持续时间和单位组件，并使用 ISO 8601 期间格式创建--ITRPDU。该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ITRPDU"且 SUPP--.QLABEL = "中断持续时间"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | (UNIT) （单位） | The unit is pre-printed on the CRF or a field provided on the CRF to capture it. 该单位已预先打印在 CRF 上，或在 CRF 上提供的字段中以捕获它。 |
| Interventions 干预措施 | N/A | 40 | --TRTCMP | Completed Treatment 完成治疗 | An indication of whether or not the subject completed the intended regimen. 一个指示，表明受试者是否完成了预定的方案。 | Did the subject complete [treatment/ the full course/ sponsor provided phrase] (of the [--TRT/Intervention])? 受试者是否完成了[治疗/完整疗程/赞助商提供的短语]（[--TRT/干预]）？ | Completed [--TRT/Intervention] 已完成 [--TRT/干预] | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--TRTCMP" and SUPP--.QLABEL ="Completed Treatment". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--TRTCMP"且 SUPP--.QLABEL = "完成治疗"。有关在 SDTM 域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | (NY) （纽约） | This could be used when treatment is given as a fixed number of cycles and the sponsor needs a flag to indicate that the treatment has been completed as planned. 这可以在治疗以固定周期进行时使用，赞助方需要一个标志来指示治疗已按计划完成。 |
| Interventions 干预措施 | N/A | 41 | --NCF | Never Current Former Usage 从不当前的前使用 | An indication of whether the substance was used and when it was used. 该物质是否被使用及使用时间的指示。 | Has the subject ever [used/consumed] [--TRT/Intervention]? 受试者是否曾经使用过[--TRT/干预]? | Usage 使用方法 | Char 字符 | --OCCUR; --STRTPT; --STRF; --ENRTPT; --ENRF --发生; --起点; --起始; --终点; --结束 | This does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable --OCCUR. If --NCF = "Never", the value of --OCCUR will be "N". If --NCF = "Current" or "Former", the value of --OCCUR will be "Y". May also be used to populate a value into an SDTM relative timing variable such as --STRTPT or --STRF. If the value of --NCF is "Former", the value of "BEFORE" may be used. If the value of --NCF is "current", the value of "ONGOING" may be used. When populating --STRTPT, if the value of --NCF is "Former", the value of "BEFORE" may be used. Note: --STRTPT must refer to a time point anchor described in --STTPT. This variable may also be used to populate the SDTM ending relative timing variables. 这并不直接映射到 SDTM 变量。可以用来填充 SDTM 变量--OCCUR 的值。如果--NCF = "从未"，则--OCCUR 的值将为"N"。如果--NCF = "当前"或"以前"，则--OCCUR 的值将为"Y"。也可以用来填充 SDTM 相对时间变量，如--STRTPT 或--STRF。如果--NCF 的值为"以前"，可以使用"BEFORE"的值。如果--NCF 的值为"当前"，可以使用"ONGOING"的值。在填充--STRTPT 时，如果--NCF 的值为"以前"，可以使用"BEFORE"的值。注意：--STRTPT 必须指向--STTPT 中描述的时间点锚。这变量也可以用来填充 SDTM 结束相对时间变量。 | (NCF) | The preferred SDTM mapping is provided. This information is usually not submitted in a SUPP--.QVAL dataset. 提供了首选的 SDTM 映射。此信息通常不会在 SUPP--.QVAL 数据集中提交。 |
| Interventions 干预措施 | N/A | 42 | --PRIOR | Prior Intervention 先前干预 | An Indication whether or not an intervention started or occurred prior to study start or timepoint (e.g., an MRI). 干预是否在研究开始或时间点之前开始或发生的指示（例如，MRI）。 | Was the [--TRT/Intervention] [taken/performed/used/administered/consumed] prior to the [study/study-specific time point or period]?; Did the [--TRT/Intervention] [start/occur] prior to the [study/study-specific time point or period]? 在[研究/研究特定时间点或期间]之前是否进行了[--TRT/干预]？[--TRT/干预]是否在[研究/研究特定时间点或期间]之前开始？ | [Taken/Performed/Used/Administered/Consumed/Started/Occurred] Prior to the [Study/Study-Specific Time Point or Period] 在[研究/研究特定时间点或期间]之前[进行/执行/使用/管理/消费/开始/发生] | Char 字符 | --STRTPT; --STRF | This does not map directly to an SDTM variable. May be used to populate a value into an SDTM relative timing variable such as --STRF or --STRTPT. When populating --STRF, or --STRTPT, if the value of the CDASH field --PRIOR is "Y" a value from the CDISC CT (STENRF) may be used. When --PRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable --STRF should be populated. When --PRIOR is compared to any other timepoint, the SDTM variables --STRTPT and --STTPT should be used. Note: --STRTPT must refer to the time point anchor described in --STTPT. 这并不直接映射到 SDTM 变量。可以用于填充 SDTM 相对时间变量，如--STRF 或--STRTPT。当填充--STRF 或--STRTPT 时，如果 CDASH 字段--PRIOR 的值为“Y”，则可以使用 CDISC CT (STENRF)中的值。当--PRIOR 指的是研究参考期（在 DM.RFSTDTC 到 DM.RFENDTC 中定义）时，应填充 SDTM 变量--STRF。当--PRIOR 与任何其他时间点进行比较时，应使用 SDTM 变量--STRTPT 和--STTPT。注意：--STRTPT 必须指代--STTPT 中描述的时间点锚。 | (NY) （纽约） | The CDASH field --PRIOR allows specific question text/prompt about interventions starting or occurred/taken/performed prior to the study or given timepoint. Select the appropriate text when designing the CRF. This may also be included in the CRF title or instructions. Used in conjunction with either a reference timepoint (--STTPT, --ENTPT) or in conjunction with the Study Reference Period (described as RFSTDTC to RFENDTC). May also be used as a tick/checkbox. See the CDASH IG Section 3.7 for more information. CDASH 字段--PRIOR 允许关于在研究或给定时间点之前开始或发生/采取/执行的干预的特定问题文本/提示。在设计 CRF 时选择适当的文本。这也可以包含在 CRF 标题或说明中。与参考时间点（--STTPT，--ENTPT）或与研究参考期（描述为 RFSTDTC 到 RFENDTC）结合使用。也可以用作勾选框。有关更多信息，请参见 CDASH IG 第 3.7 节。 |
| Interventions 干预措施 | N/A | 43 | --ONGO | Ongoing Intervention 持续干预 | An indication whether the intervention is ongoing as of a given timepoint when no End Date is provided. 一个指示，表明在没有提供结束日期的情况下，干预是否在给定时间点上仍在进行。 | [Is/Was] the [--TRT/ Intervention] ongoing (as of [the study-specific timepoint or period])? [在研究特定时间点或期间]，[--TRT/干预]是否正在进行？ | Ongoing (as of the [Study-Specific Timepoint or Period]) 进行中（截至[研究特定时间点或期间]） | Char 字符 | --ENRTPT; --ENRF | This does not map directly to an SDTM variable. May be used to populate a value into an SDTM relative timing variable such as --ENRF or --ENRTPT. When populating --ENRF, or --ENRTPT, if the value of the CDASH field --ONGO is "Y" a value from the CDISC CT (STENRF) may be used. When --ONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable --ENRF should be populated. When --ONGO is compared to any other timepoint, the SDTM variables --ENRTPT and --ENTPT should be used. Note: --ENRTPT must refer to the time point anchor described in --ENTPT. 这并不直接映射到 SDTM 变量。可以用于填充 SDTM 相对时间变量，如--ENRF 或--ENRTPT。当填充--ENRF 或--ENRTPT 时，如果 CDASH 字段--ONGO 的值为“Y”，则可以使用 CDISC CT 中的值（STENRF）。当--ONGO 指的是研究参考期（在 DM.RFSTDTC 到 DM.RFENDTC 中定义）时，应填充 SDTM 变量--ENRF。当--ONGO 与任何其他时间点进行比较时，应使用 SDTM 变量--ENRTPT 和--ENTPT。注意：--ENRTPT 必须指代--ENTPT 中描述的时间点锚。 | (NY) （纽约） | The CDASH field --ONGO allows specific question text/prompt about interventions ending after the study or after a given timepoint. Select the appropriate text when designing the CRF. This may also be included in the CRF title or instructions. Used in conjunction with either a reference timepoint (--ENTPT, --ENRTPT) or in conjunction with the Study Reference Period (described as RFSTDTC to RFENDTC). May also be used as a tick/checkbox. See the CDASH IG Section 3.7 for more information. CDASH 字段--ONGO 允许关于干预在研究结束后或在给定时间点后结束的特定问题文本/提示。在设计 CRF 时选择适当的文本。这也可以包含在 CRF 标题或说明中。与参考时间点（--ENTPT，--ENRTPT）或与研究参考期间（描述为 RFSTDTC 到 RFENDTC）一起使用。也可以用作勾选框。有关更多信息，请参见 CDASH IG 第 3.7 节。 |
| Interventions 干预措施 | N/A | 44 | COVAL | [domain specific label] [领域特定标签] | A free text comment. 免费文本评论。 | [Protocol-specified Targeted Question]? [协议指定的针对性问题]? | [Abbreviated version of the protocol-specified targeted question] [协议规定的目标问题的简化版本] | Char 字符 | CO.COVAL | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable --COVAL maps to the SDTM variable COVAL (COVAL2, COVAL3) in the CO domain. Associate the free text comment in the CO domain with the original record using RDOMAIN, IDVAR, IDVARVAL, COREF. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量--COVAL 映射到 CO 领域中的 SDTM 变量 COVAL（COVAL2，COVAL3）。使用 RDOMAIN、IDVAR、IDVARVAL、COREF 将 CO 领域中的自由文本评论与原始记录关联起来。 | N/A | If an additional free text field is needed to provide a comment about a particular record, use the COVAL(n) field to collect the free text, and associate the free text comment with the original record using SDTM variables RDOMAIN, IDVAR, IDVARVAL, COREF. See the SDTMIG for more information. 如果需要额外的自由文本字段来提供关于特定记录的评论，请使用 COVAL(n) 字段收集自由文本，并使用 SDTM 变量 RDOMAIN、IDVAR、IDVARVAL、COREF 将自由文本评论与原始记录关联。有关更多信息，请参见 SDTMIG。 |
| Interventions 干预措施 | N/A | 45 | --MODIFY | Modified Treatment Name 修改后的治疗名称 | If the value for --TRT is modified for coding purposes, then the modified text is placed here. 如果为了编码目的修改了 --TRT 的值，则修改后的文本放在这里。 | N/A | N/A | Char 字符 | --MODIFY | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Interventions 干预措施 | N/A | 46 | --CLAS | Class Description 课程描述 | The class for the intervention, often obtained from a coding dictionary. 干预的类别，通常从编码字典中获得。 | N/A | N/A | Char 字符 | --CLAS | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the interventions utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。赞助商应提供用于编码干预措施的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). This would generally be the class used for analysis. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。这通常是用于分析的类别。 |
| Interventions 干预措施 | N/A | 47 | --CLASCD | Class Code 班级代码 | The assigned dictionary code for the class for the intervention. 该干预班级的指定词典代码。 | N/A | N/A | Char 字符 | --CLASCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the interventions utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。赞助商应提供用于编码干预措施的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). This would generally be the class used for analysis. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。这通常是用于分析的类别。 |
| Interventions 干预措施 | N/A | 48 | --ATC1 | ATC Level 1 Description ATC 1 级描述 | The first level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the anatomical main group. 解剖治疗化学分类系统中的第一级层级。指示解剖主要组。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM= "--ATC1" and SUPP--QLABEL= "ATC Level 1 Description". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 此信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM= "--ATC1"且 SUPP--QLABEL= "ATC Level 1 Description"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 49 | --ATC1CD | ATC Level 1 Code ATC 一级代码 | The assigned Dictionary Code denoting the first level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the anatomical main group. 分配的字典代码表示解剖治疗化学分类系统中的第一级层次。指示解剖主要组。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC1CD" and SUPP--.QLABEL="ATC Level 1 Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC1CD"且 SUPP--.QLABEL="ATC Level 1 Code"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 50 | --ATC2 | ATC Level 2 Description ATC Level 2 描述 | The second level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the therapeutic main group. 解剖治疗化学分类系统中的第二级层次。指示治疗主要组。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = --ATC2 and SUPP--QLABEL="ATC Level 2 Description". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = --ATC2，SUPP--QLABEL="ATC Level 2 Description"。请参阅当前的 SDTM 和 SDTMIG，以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 51 | --ATC2CD | ATC Level 2 Code ATC 级别 2 代码 | The assigned Dictionary Code denoting the second level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the therapeutic main group. 分配的字典代码表示解剖治疗化学分类系统中的第二级层次。指示治疗主要组。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = --ATC2CD and SUPP--.QLABEL="ATC Level 2 Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = --ATC2CD，SUPP--.QLABEL="ATC Level 2 Code"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 52 | --ATC3 | ATC Level 3 Description ATC 三级描述 | The third level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the therapeutic/pharmacological subgroup. 解剖治疗化学分类系统中的第三层级。表示治疗/药理亚组。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC3" and SUPP--QLABEL="ATC Level 3 Description". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC3"且 SUPP--QLABEL="ATC Level 3 Description"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 53 | --ATC3CD | ATC Level 3 Code ATC 三级代码 | The assigned Dictionary Code denoting the third level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the therapeutic/pharmacological subgroup. 分配的字典代码表示解剖治疗化学分类系统中的第三层级。指示治疗/药理亚组。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC3CD" and SUPP--.QLABEL="ATC Level 3 Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC3CD"且 SUPP--.QLABEL="ATC 三级代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“分配的”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 54 | --ATC4 | ATC Level 4 Description ATC 级别 4 描述 | The fourth level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the chemical/therapeutic/pharmacological subgroup. 解剖治疗化学分类系统中的第四级层次。表示化学/治疗/药理亚组。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC4" and SUPP--QLABEL="ATC Level 4 Description". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC4"且 SUPP--QLABEL="ATC Level 4 Description"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 55 | --ATC4CD | ATC Level 4 Code ATC 级别 4 代码 | The assigned Dictionary Code denoting the fourth level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the chemical/therapeutic/pharmacological subgroup. 分配的字典代码表示解剖治疗化学分类系统中的第四层级。指示化学/治疗/药理亚组。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--ATC4CD" and SUPP--.QLABEL="ATC Level 4 Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 此信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM = "--ATC4CD" 和 SUPP--.QLABEL="ATC 级别 4 代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个来源列，以指示数据为“分配”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 56 | --ATC5 | ATC Level 5 Description ATC 级别 5 描述 | The fifth level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the chemical substance. 解剖治疗化学分类系统中的第五级层次。表示化学物质。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC5" and SUPP--.QLABEL="ATC Level 5 Description". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC5"且 SUPP--.QLABEL="ATC Level 5 Description"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 57 | --ATC5CD | ATC Level 5 Code ATC 5 级代码 | The assigned Dictionary Code denoting the fifth level of hierarchy within the Anatomical Therapeutic Chemical Classification System. Indicates the chemical substance. 分配的字典代码表示解剖治疗化学分类系统中的第五层级。指示化学物质。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--ATC5CD" and SUPP--.QLABEL="ATC Level 5 Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--ATC5CD"且 SUPP--.QLABEL="ATC Level 5 Code"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“ASSIGNED”。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process (e.g., WHO Drug). Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This is an example of variables that could be used in the CM domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程（例如，WHO 药物）来填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。这是可以在 CM 领域用于编码的变量示例。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 58 | --INGRD | Active Ingredients 活性成分 | A description of the active ingredients used in the medication taken or administered 药物中使用或施用的活性成分的描述 | What [are/were] the active ingredients? 活性成分是什么？ | Active Ingredients 活性成分 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--INGRID" and SUPP--.QLABEL= "Active Ingredients". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM = "--INGRID"和 SUPP--.QLABEL = "活性成分"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | N/A | This may be collected in addition to the Medication/Therapy Name. Collecting this provides more detailed information when coding to a medication dictionary like WHO Drug Enhanced format C which now codes to the ingredient level for many trade named medications. 这可以在药物/治疗名称之外收集。收集这些信息在编码到药物字典时提供了更详细的信息，例如 WHO 药物增强格式 C，该格式现在对许多商品名药物进行成分级编码。 |
| Interventions 干预措施 | N/A | 59 | --LLT | Lowest Level Term 最低级术语 | MedDRA Dictionary text description of the Lowest Level Term. MedDRA 字典中最低级别术语的文本描述。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = " --LLT" and SUPP--.QLABEL = "Lower Level Term". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = " --LLT"且 SUPP--.QLABEL = "下级术语"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“分配”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Another dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 60 | --LLTCD | Lowest Level Term Code 最低级别术语代码 | MedDRA Dictionary Lowest Level Term code. MedDRA 字典最低级别术语代码。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM= "--LLTCD" and SUPP--.QLABEL = "Lower Level Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM= "--LLTCD"和 SUPP--.QLABEL = "下级术语代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Another dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 61 | --PTCD | Preferred Term Code 首选术语代码 | MedDRA Dictionary code for the Preferred Term. MedDRA 字典代码用于首选术语。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--PTCD" and SUPP--.QLABEL= "Preferred Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM = "--PTCD"和 SUPP--.QLABEL = "首选术语代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“分配”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Another dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果合适，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 62 | --HLT | High Level Term 高级术语 | MedDRA Dictionary text description of the High Level Term from the primary path. MedDRA 字典中关于主要路径的高层术语的文本描述。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--HLT" and SUPP--.QLABEL = "High Level Term". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--HLT"且 SUPP--.QLABEL = "高层术语"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 63 | --HLTCD | High Level Term Code 高级术语代码 | MedDRA Dictionary High Level Term code from the primary path. MedDRA 字典高层术语代码来自主要路径。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM= "--HLTCD" and SUPP--.QLABEL="High Level Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". 该信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM="--HLTCD"和 SUPP--.QLABEL="高层术语代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在定义元数据文档中包含一个 Origin，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 64 | --HLGT | High Level Group Term 高级小组术语 | MedDRA Dictionary text description of the High Level Group Term from the primary path. MedDRA 字典中关于主要路径的高层组术语的文本描述。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--HLTGT" and SUPP--.QLABEL= "High Level Group Term". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--HLTGT"且 SUPP--.QLABEL = "高层次组术语"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 65 | --HLGTCD | High Level Group Term Code 高级组别术语代码 | MedDRA High Level Group Term code from the primary path. MedDRA 高层次组别术语代码来自主要路径。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--HLTGTCD" and SUPP--.QLABEL = "High Level Group Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--HLTGTCD"且 SUPP--.QLABEL = "高层次组术语代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 66 | --SOC | Primary System Organ Class 主要系统器官分类 | MedDRA Primary System Organ Class description associated with the intervention. 与干预相关的 MedDRA 主要系统器官分类描述。 | N/A | N/A | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--SOC" and SUPP--.QLABEL = "Primary System Organ Class". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". 此信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM = "--SOC" 和 SUPP--.QLABEL = "主要系统器官类别"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 域中放置非标准变量的说明。赞助商应在定义元数据文档中包含一个来源，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
| Interventions 干预措施 | N/A | 67 | --SOCCD | Primary System Organ Class Code 主要系统器官分类代码 | MedDRA primary System Organ Class code. MedDRA 主要系统器官分类代码。 | N/A | N/A | Num 数字 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--SOCCD" and SUPP--.QLABEL = "Primary System Organ Class Code". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--SOCCD"且 SUPP--.QLABEL = "主要系统器官类别代码"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。赞助商应在 SUPPQ 数据集中包含一个 Origin 列，以指示数据为“ASSIGNED”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. This variable could be used in the PR domain for coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPP--.QVAL dataset. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。该变量可以在 PR 领域用于编码。如果适用，可以使用其他字典并在 SUPP--.QVAL 数据集中添加适当的编码元素。 |
2.2 Events 2.2 事件
Events 事件
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Events 事件 | N/A | 1 | --YN | Any [Event] 任何[事件] | An indication whether or not any data was collected for the event topic. 事件主题是否收集了任何数据的指示。 | Has the subject had any [event topic(s)/term/name] (after/before [study specific time frame])?; [Was/Were] (there) any [event topic(s)] (reported) (after/before [study specific time frame])? 该主题在[研究特定时间范围]之前/之后是否有任何[事件主题/术语/名称]？; [是否]有任何[事件主题]（报告）在[研究特定时间范围]之前/之后？ | Any [Event Topic] 任何[事件主题] | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | This is a field that can be used on any events CRF to indicate whether or not there is data to record. Used primarily as a data cleaning field. This provides verification that all other fields on the CRF were deliberately left blank. If the response of YES/NO, is planned to be submitted in the SDTM submission datasets, this CDASH variable should not be used and the appropriate CDASH variable should be used instead (e.g., --OCCUR). 这是一个可以在任何事件 CRF 上使用的字段，用于指示是否有数据需要记录。主要用作数据清理字段。这提供了验证，确保 CRF 上的所有其他字段都是故意留空的。如果计划在 SDTM 提交数据集中提交 YES/NO 的响应，则不应使用此 CDASH 变量，而应使用适当的 CDASH 变量（例如，--OCCUR）。 |
| Events 事件 | N/A | 2 | --TERM | Reported Term 报告的术语 | The topic variable for an event observation, which is the reported or pre-specified name of the event. 事件观察的主题变量，即事件的报告名称或预先指定名称。 | What [is/was] the [event topic/term/name]?; If --DECOD (is selected), [explain/specify/provide (more) detail(s)]? 事件主题是什么？如果选择了--DECOD，请提供更多细节 | [Event Topic]; [Specify/Specify Other/Explain/Provide Details ([for Event Topic]) [事件主题]; [指定/指定其他/解释/提供详细信息（[针对事件主题]）] | Char 字符 | --TERM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Typically, --TERM collects the verbatim text for an Event. If the term is preprinted/pre-specified, the value can be populated into the --TERM variable as a hidden field e.g., if Headache is preprinted on an AE CRF, "Headache" should be stored in AETERM. The CDASH field --TERM can also be used to collect any free text values linked to the sponsor-standardized value collected in the CDASH field --DECOD. For example, --DECOD may have a value of "OTHER" and the associated free text event topic is collected in --TERM. In this scenario, the Item prompt "Specify Other" may be used. 通常，--TERM 收集事件的逐字文本。如果术语是预印刷/预先指定的，则可以将该值作为隐藏字段填充到 --TERM 变量中，例如，如果头痛在 AE CRF 上预印刷，则“头痛”应存储在 AETERM 中。CDASH 字段 --TERM 也可以用于收集与在 CDASH 字段 --DECOD 中收集的赞助商标准化值相关的任何自由文本值。例如，--DECOD 的值可能为“其他”，相关的自由文本事件主题收集在 --TERM 中。在这种情况下，可以使用项目提示“指定其他”。 |
| Events 事件 | N/A | 3 | --DECOD | Dictionary-Derived/Standardized Term 字典派生/标准化术语 | The dictionary or sponsor-defined standardized text description of the topic variable, --TERM, or the modified topic variable (-- MODIFY), if applicable. 主题变量的字典或赞助商定义的标准化文本描述，--TERM，或修改后的主题变量（--MODIFY），如适用。 | What [is/was] the [event/event topic]? 事件是什么？ | (Standardized) [Event/Event Topic] （标准化）[事件/事件主题] | Char 字符 | --DECOD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". If the sponsor uses a dictionary to code the --TERM, it expected that the dictionary name and version is provided in the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。如果赞助商使用字典对--TERM 进行编码，则预计在 Define-XML 外部代码列表属性中提供字典名称和版本。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | When populated by the a coding dictionary such as MedDRA, Question Text and Prompt may not be applicable. This is equivalent to the Preferred Term (PT) in MedDRA. The CDISC Controlled terminology (NCOMPLT) is used for the DS Domain only. The CDASH field --DECOD may be used to collect standardized pre-specified values (CDISC Controlled Terminology or Sponsor-defined Terminology) on a CRF. The CDASH field --TERM can be used to collect any free text values linked to the sponsor-standardized value. For example, the CDASH field --DECOD may have a value of "OTHER" and the associated free text event topic is collected in the CDASH field --TERM. 当由像 MedDRA 这样的编码词典填充时，问题文本和提示可能不适用。这相当于 MedDRA 中的优选术语（PT）。CDISC 控制术语（NCOMPLT）仅用于 DS 领域。CDASH 字段 --DECOD 可用于在 CRF 上收集标准化的预先指定值（CDISC 控制术语或赞助商定义的术语）。CDASH 字段 --TERM 可用于收集与赞助商标准化值相关的任何自由文本值。例如，CDASH 字段 --DECOD 可能具有“其他”的值，相关的自由文本事件主题在 CDASH 字段 --TERM 中收集。 |
| Events 事件 | N/A | 4 | --CAT | Category 类别 | A grouping of topic-variable values based on user-defined characteristics. 基于用户定义特征的主题变量值分组。 | What [is/was] the category (of the [--TERM/event topic])? 该[--TERM/事件主题]的类别是什么？ | [Category/Category Value]; NULL [类别/类别值]; NULL | Char 字符 | --CAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "category" can be included as the column header. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. 赞助商定义的受控术语。这通常是在 CRF 或屏幕上的标题，而不是站点提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。如果提出问题，回答通常是赞助商定义的代码列表。如果表格布局为网格，则可以将“类别”等词作为列标题。示例在 CDASHIG 元数据表或 SDTMIG 中提供。 |
| Events 事件 | N/A | 5 | --SCAT | Subcategory 子类别 | A sub-division of the --CAT values based on user-defined characteristics. 基于用户定义特征的--CAT 值的子划分。 | What [is/was] the subcategory (of the [--TERM/event topic])? 该[--术语/事件主题]的子类别是什么？ | [Subcategory/Subcategory Value]; NULL [子类别/子类别值]; NULL | Char 字符 | --SCAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. 赞助商定义的受控术语。这通常是 CRF 或屏幕上的一个标题，而不是站点需要提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。 |
| Events 事件 | N/A | 6 | --PRESP | Pre-Specified 预先指定 | An indication that a specific event, or group of events, is pre-specified on a CRF. 在 CRF 上预先指定特定事件或事件组的指示。 | N/A | N/A | Char 字符 | --PRESP | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | For pre-specified events a hidden field on a CRF defaulted to Y, or added during the SDTM dataset creation. If a study collects both pre-specified events as well as free-text events, the value of --PRESP should be Y for all pre-specified events and null for events reported as free-text. 对于预先指定的事件，CRF 上的隐藏字段默认为 Y，或在 SDTM 数据集创建时添加。如果研究同时收集预先指定的事件和自由文本事件，则所有预先指定的事件的--PRESP 值应为 Y，而自由文本报告的事件应为 null。 |
| Events 事件 | N/A | 7 | --OCCUR | Occurrence 发生 | An indication whether the pre-specified event or the group of events occurred when the occurrence of the specific event or group of events is solicited. 一个指示，表明在请求特定事件或事件组发生时，预先指定的事件或事件组是否发生。 | [Did/Does] the subject have [--TERM] (after/before [study-specific time frame] )?; Is the [pre-specified medical occurring]? 该受试者在[研究特定时间框架]之前/之后是否有[--术语]？[预先指定的医疗情况]是否发生？ | [--TERM] | Char 字符 | --OCCUR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the term is preprinted/pre-specified, then the value is mapped into the --TERM variable. (e.g., if Headache is preprinted on an AE CRF, "Headache" should be stored in AETERM.) 如果术语是预先打印/预先指定的，则该值将映射到 --TERM 变量中。（例如，如果头痛在不良事件 CRF 上预先打印，则“头痛”应存储在 AETERM 中。） |
| Events 事件 | N/A | 9 | --STAT | Completion Status 完成状态 | The variable used to indicate that data are not available by having the site recording the value as "Not Done". 用于指示数据不可用的变量，通过将站点记录的值设置为“未完成”来实现。 | Was the [event topic] not [answered/ done/ assessed/evaluated] ?; Indicate if ( [event topic] was) not [answered/assessed/done/evaluated]. [事件主题]是否没有[回答/完成/评估/评价]？; 指出是否([事件主题]没有)[回答/评估/完成/评价]。 | Not Done 未完成 | Char 字符 | --STAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". If collected, the Origin (column in the Define-XML) "CRF", if populated from other sources such as a free text or sponsor-defined listing for --REASND, the Origin "DERIVED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。如果收集，则来源（Define-XML 中的列）为“CRF”；如果来自其他来源（例如自由文本或赞助商定义的--REASND 列表），则来源为“衍生”。 | (ND) | A "Not Done" check box, which indicates the data is not available/question was not asked. Typically, there would be one check box for each pre-specified event. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank. 一个“未完成”复选框，表示数据不可用/问题未被询问。通常，每个预先指定的事件会有一个复选框。当询问多个问题时，此字段可以用来确认空结果字段确实是空的。 |
| Events 事件 | N/A | 10 | --CSTAT | Collected Completion Status 收集的完成状态 | The variable used to indicate that data are not available by having the site recording a sponsor-defined value (e.g., Not Collected/Not Evaluated/Not Assessed/Not Available/Not Answered). 用于指示数据不可用的变量，通过让站点记录赞助商定义的值（例如：未收集/未评估/未评定/不可用/未回答）。 | Was the [event topic] not [answered/ done/ assessed/evaluated] ?; Indicate if ( [event topic] was) not [answered/assessed/done/evaluated]. [事件主题]是否没有[回答/完成/评估/评价]？; 指出是否([事件主题]没有)[回答/评估/完成/评价]。 | Not Collected 未收集 | Char 字符 | --STAT | This does not map directly to an SDTM variable. For the SDTM dataset, the SDTM variable --STAT is populated by mapping the value of the CDASH variable CSTAT "NOT COLLECTED" to "NOT DONE". If collected, the Origin (column in the Define-XML) "CRF", if populated from other sources such as a free text or sponsor-defined listing for --REASND, the Origin "DERIVED". 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，SDTM 变量--STAT 通过将 CDASH 变量 CSTAT 的值“未收集”映射为“未完成”来填充。如果已收集，来源（Define-XML 中的列）为“CRF”，如果是从其他来源填充，例如自由文本或赞助商定义的--REASND 列表，则来源为“派生”。 | N/A | Used only when the response value is collected as NOT COLLECTED or NULL in lieu of or in addition to the CDASH --PERF field. Typically a check box which indicates the information about the event topic was NOT COLLECTED. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank. The users may replace the response of "NOT COLLECTED" as appropriate (e.g. Not Asked, Not Evaluated) in collection but the response must be mapped to the SDTM variable --STAT as "NOT DONE". 仅在响应值被收集为“未收集”或“NULL”时使用，以替代或补充 CDASH --PERF 字段。通常是一个复选框，表示事件主题的信息未被收集。当询问多个问题以确认空结果字段确实是空白时，此字段可能会很有用。用户可以在收集时根据需要替换“未收集”的响应（例如，未询问，未评估），但响应必须映射到 SDTM 变量--STAT 为“未完成”。 |
| Events 事件 | N/A | 11 | --REASND | Reason Not Done 原因未完成 | An explanation of why the assessment/evaluation/question was not answered/collected/done, etc. 未回答/收集/完成评估/评价/问题的原因说明。 | What [is/was] the reason that the ( [data/information/ sponsor-defined phrase] ) was not [answered/collected/ done/ evaluated/ assessed]? 是什么原因导致（[数据/信息/赞助商定义的短语]）没有被[回答/收集/完成/评估/评定]? | Reason Not [ Answered/ Collected/ Done/ Evaluated/ Assessed/Available] 原因未[回答/收集/完成/评估/评定/可用] | Char 字符 | --REASND | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology may be used. The reason the data was not done/not collected may be chosen from a select list (for example, broken equipment, subject refused, etc.) or entered as free text. When --REASND is used, --STAT should also be populated in the SDTM dataset. 赞助商定义的受控术语可以使用。数据未完成/未收集的原因可以从一个选择列表中选择（例如，设备损坏、受试者拒绝等）或作为自由文本输入。当使用--REASND 时，--STAT 也应在 SDTM 数据集中填充。 |
| Events 事件 | N/A | 12 | --LOC | Location 位置 | A description of the anatomical location relevant for the event. 与该事件相关的解剖位置描述。 | What [is/was] the anatomical location (of the [--TERM/event topic])? 该[--术语/事件主题]的解剖位置是什么？ | Anatomical Location 解剖位置 | Char 字符 | --LOC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LOC) (地点) | This may be pre-printed or collected. --LOC is used only to specify the anatomical location. --LAT, --DIR, --PORTOT are used to further describe the anatomical location. 这可以是预先打印的或收集的。--LOC 仅用于指定解剖位置。--LAT、--DIR、--PORTOT 用于进一步描述解剖位置。 |
| Events 事件 | N/A | 13 | --LAT | Laterality 侧向性 | Qualifier for anatomical location further detailing the side of the body relevant for the event. 与事件相关的身体侧面进一步详细说明的解剖位置限定词。 | What [is/was] the side (of the anatomical location of the event)? 事件的解剖位置是哪个侧面？ | Side 侧面 | Char 字符 | --LAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LAT) | Further detailing the laterality of the location of the --TERM. This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF. 进一步详细说明--TERM 的位置的侧向性。这可以是预先打印的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Events 事件 | N/A | 14 | --DIR | Directionality 方向性 | Qualifier further detailing the position of the anatomical location relative to the center of the body, organ, or specimen. 进一步说明解剖位置相对于身体、器官或标本中心的定性描述。 | What [is/was] the directionality (of the anatomical location)? 解剖位置的方向性是什么？ | Directionality 方向性 | Char 字符 | --DIR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (DIR) | Further detailing the directionality of the location of the --TERM (e.g., ANTERIOR, LOWER, PROXIMAL). This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF. 进一步详细说明--TERM 的位置方向（例如，前部、下部、近端）。这可以是预先打印的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Events 事件 | N/A | 15 | --PORTOT | Portion or Totality 部分或整体 | Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. 解剖位置的限定词进一步详细说明了分布，这意味着排列和分配。 | What [is/was] the portion or totality of the (anatomical location) involved? 涉及的（解剖位置）的部分或整体是多少？ | Portion or Totality 部分或整体 | Char 字符 | --PORTOT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (PORTOT) （波尔图） | Further detailing the portion or totality of the location of the --TERM. This may be pre-printed or collected. 进一步详细说明--TERM 的位置部分或整体。这可以是预先打印的或收集的。 |
| Events 事件 | N/A | 16 | --PARTY | Accountable Party 责任方 | The party accountable for the transferable object (e.g., device, specimen) as a result of the activity performed in the associated --TERM variable. 负责可转让对象（例如设备、样本）的方是由于在相关--TERM 变量中执行的活动而产生的。 | Who [is/was] the accountable party? 谁是/曾是负责方？ | Accountable Party 责任方 | Char 字符 | --PARTY | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the -- PRTYID variable (e.g., SITE, SPONSOR, SUBJECT) 赞助商定义的受控术语。该方可以是个人（例如，受试者）、组织（例如，赞助商）或作为个人或组织代理的地点（例如，站点）。这通常是一个相对通用的术语，在 -- PRTYID 变量中进一步识别（例如，SITE、SPONSOR、SUBJECT）。 |
| Events 事件 | N/A | 17 | --PRTYID | Identification of Accountable Party 可追责方的识别 | Identification of the specific party accountable for the transferable object (e.g., device, specimen) after the action in -- TERM is taken. 在采取--TERM 行动后，识别对可转让对象（例如，设备、样本）负责的特定方。 | What [is/was] the accountable party identifier? 可追溯方标识符是什么？ | Accountable Party ID 责任方 ID | Char 字符 | --PRTYID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Used in conjunction with --PARTY. This identifier is defined by the sponsor. 与 --PARTY 一起使用。此标识符由赞助商定义。 |
| Events 事件 | N/A | 18 | --SEV | Severity/Intensity 严重性/强度 | The severity or intensity of the event. 事件的严重性或强度。 | What [is/was] the severity (of the event topic)? 事件主题的严重性如何？ | Severity 严重性 | Char 字符 | --SEV | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | In the AE domain, AESEV uses CDISC Controlled Terminology (AESEV). 在 AE 领域，AESEV 使用 CDISC 控制术语（AESEV）。 |
| Events 事件 | N/A | 19 | --ACN | Action Taken with Study Treatment 采取的行动与研究治疗 | A description of the action taken with study treatment as a result of the event. 因事件而采取的研究治疗措施的描述。 | What action was taken with study treatment? 对研究治疗采取了什么措施？ | Action Taken with Study Treatment 采取的行动与研究治疗 | Char 字符 | --ACN | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (ACN) | How to handle multiple actions taken is sponsor-specific decision. This variable is not to be used for actions taken with devices. See the SDTM Device IG for information on reporting multiple actions, or actions with multiple devices. 如何处理多个采取的行动是特定于赞助商的决定。此变量不应用于与设备相关的行动。有关报告多个行动或与多个设备相关的行动的信息，请参见 SDTM 设备指南。 |
| Events 事件 | N/A | 20 | --SER | Serious Event 严重事件 | An indication whether or not this event met the definition of serious. 该事件是否符合严重事件的定义的指示。 | [Is/Was] [the event topic/it] serious? 这个事件的主题/它严重吗？ | Serious 严重 | Char 字符 | --SER | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | N/A |
| Events 事件 | N/A | 21 | --ACNOTH | Other Actions Taken 其他采取的行动 | A description of other action(s) taken as a result of the event that are unrelated to dose adjustments of the study treatment. 事件导致的其他行动的描述，这些行动与研究治疗的剂量调整无关。 | What other action(s) [were/was] taken? 采取了什么其他行动？ | Other Actions Taken 其他采取的行动 | Char 字符 | --ACNOTH | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Events 事件 | N/A | 22 | --ACNDEV | Actions Taken with Device 设备采取的行动 | A description of the action taken, with respect to a device used in a study, which may or may not be the device under study, as a result of the event. 对事件结果采取的行动的描述，涉及在研究中使用的设备，该设备可能是正在研究的设备，也可能不是。 | What action was taken with the device used in the study? 在研究中使用的设备采取了什么措施？ | Action Taken with Device 设备已采取的行动 | Char 字符 | --ACNDEV | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This variable is intended to be used like --ACN, but is about the device rather than the study treatment. See the SDTM Device IG for information on reporting multiple actions, or actions with multiple devices. 赞助商定义的受控术语。该变量旨在像 --ACN 一样使用，但与设备有关，而不是研究治疗。有关报告多个操作或多个设备操作的信息，请参见 SDTM 设备 IG。 |
| Events 事件 | N/A | 23 | --REL | Causality 因果关系 | The investigator's opinion as to the relationship of the event to the study treatment. 调查员对事件与研究治疗之间关系的看法。 | [Is/Was] this event related to study treatment? 该事件与研究治疗有关吗？ | Relationship to Study Treatment 研究治疗的关系 | Char 字符 | --REL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. ICH E2A and E2B examples include NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED. 赞助商定义的受控术语。ICH E2A 和 E2B 的示例包括：无关、可能无关、可能相关、相关。 |
| Events 事件 | N/A | 24 | --RELNST | Relationship to Non-Study Treatment 与非研究治疗的关系 | A description of the investigator's opinion as to whether the event may have been due to a treatment other than study treatment. 调查员对事件是否可能由于研究治疗以外的其他治疗的意见描述。 | What [is/was] the relationship to non-study treatment? 非研究治疗的关系是什么？ | Relationship to Non-Study Treatment 与非研究治疗的关系 | Char 字符 | --RELNST | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | May be reported as free text. Example: "MORE LIKELY RELATED TO ASPIRIN USE. 可能以自由文本形式报告。例如：“更可能与阿司匹林使用有关。” |
| Events 事件 | N/A | 25 | --PATT | Pattern of Event 事件模式 | A description of the pattern of the event over time. 事件随时间变化的模式描述。 | What [is/was] the pattern of the event over time? 事件随时间的模式是什么？ | Pattern 图案 | Char 字符 | --PATT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. 赞助商定义的受控术语。 |
| Events 事件 | N/A | 26 | --OUT | Outcome of Event 事件结果 | A description of the outcome of an event. 事件结果的描述。 | What [is/was] the outcome (of the event/event topic) ? 事件的结果是什么？ | Outcome 结果 | Char 字符 | --OUT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | CDISC Controlled Terminology (OUT) is used in the AE domain. CDISC 控制术语 (OUT) 用于不良事件 (AE) 领域。 |
| Events 事件 | N/A | 39 | --CONTRT | Concomitant or Additional Trtmnt Given 伴随或额外治疗给予 | An indication whether a concomitant or additional treatment given because of the occurrence of the event. 是否因事件发生而给予的伴随或额外治疗的指示。 | Was a concomitant or additional treatment given (due to this [event])? 是否因该事件给予了伴随或额外的治疗？ | Concomitant or Additional Trtmnt Given 伴随或额外治疗给予 | Char 字符 | --CONTRT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | N/A |
| Events 事件 | N/A | 40 | --TOX | Toxicity Description 毒性描述 | A description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. 毒性描述由 --TOXGR 量化，例如 NCI CTCAE 简称。 | N/A | N/A | Char 字符 | --TOX | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external code list attributes. 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于映射术语的毒性等级名称和版本，利用 Define-XML 外部代码列表属性。 | N/A | If used, --TOX would be populated with the decoded value from --TOXGR. For example, if the --TERM is HYPERTENSION, and the --TOXGR is "1", --TOX is populated with "Prehypertension (systolic BP 120 - 139 mm Hg or diastolic BP 80 - 89 mm Hg)" 如果使用，--TOX 将填充来自--TOXGR 的解码值。例如，如果--TERM 是高血压，--TOXGR 是“1”，则--TOX 填充为“前高血压（收缩压 120 - 139 mm Hg 或舒张压 80 - 89 mm Hg）” |
| Events 事件 | N/A | 41 | --TOXGR | Toxicity Grade 毒性等级 | The toxicity grade using a standard toxicity scale (such as the NCI CTCAE). 使用标准毒性等级（如 NCI CTCAE）评估毒性等级。 | What [is/was] the [NCI CTCAE/Name of Scale] grade? [NCI CTCAE/量表名称]的等级是什么？ | [NCI CTCAE Toxicity] Grade [NCI CTCAE 毒性]等级 | Char 字符 | --TOXGR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external code list attributes. 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于映射术语的毒性等级名称和版本，利用 Define-XML 外部代码列表属性。 | N/A | Refer to ICH E3 guidelines for CSR Section 12.2.4. CTCAE grade is commonly used in oncology studies although it can also be used elsewhere. Other published "toxicity" like scales may be used. 请参阅 ICH E3 指南中的 CSR 第 12.2.4 节。CTCAE 等级通常用于肿瘤学研究，尽管它也可以在其他地方使用。其他已发布的“毒性”量表也可以使用。 |
| Events 事件 | N/A | 42 | --PRIOR | Prior Event 先前事件 | An indication whether the event occurred prior to study start or a given timepoint. 事件是否发生在研究开始之前或某个特定时间点的指示。 | Did the [--TERM/event topic] occur [prior to the study/specific timepoint or period] ? 该[--术语/事件主题]是否发生在[研究/特定时间点或时期]之前？ | Prior to [Study/Study-Specific Time Point or Period] 在[研究/研究特定时间点或期间]之前 | Char 字符 | --STRTPT; --STRF | This does not map directly to an SDTM variable. May be used to populate a value into an SDTM relative timing variable such as --STRF or --STRTPT. When populating --STRF, or --STRTPT, if the value of the CDASH field --PRIOR is "Y" a value from the CDISC CT (STENRF) may be used. When --PRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable --STRF should be populated. When --PRIOR is compared to any other timepoint, the SDTM variables --STRTPT and --STTPT should be used. Note: --STRTPT must refer to the "time point anchor" described in --STTPT. 这并不直接映射到 SDTM 变量。可以用于填充 SDTM 相对时间变量，如--STRF 或--STRTPT。当填充--STRF 或--STRTPT 时，如果 CDASH 字段--PRIOR 的值为“Y”，则可以使用 CDISC CT (STENRF)中的值。当--PRIOR 指的是研究参考期（在 DM.RFSTDTC 到 DM.RFENDTC 中定义）时，应填充 SDTM 变量--STRF。当--PRIOR 与任何其他时间点进行比较时，应使用 SDTM 变量--STRTPT 和--STTPT。注意：--STRTPT 必须指代--STTPT 中描述的“时间点锚”。 | (NY) （纽约） | The CDASH field --PRIOR allows specific question text/prompt about events starting prior to the study or given timepoint. Select the appropriate text when designing the CRF. This may also included in the CRF title or instructions. Used in conjunction with either a reference timepoint (--STTPT, --STRTPT) or in conjunction with the Study Reference Period (described as RFSTDTC to RFENDTC). May also be used as a tick/checkbox. See the CDASH IG Section 3.7 for more information. CDASH 字段--PRIOR 允许针对研究或给定时间点之前发生的事件提出特定的问题文本/提示。在设计 CRF 时选择适当的文本。这也可以包含在 CRF 标题或说明中。与参考时间点（--STTPT，--STRTPT）或研究参考期间（描述为 RFSTDTC 到 RFENDTC）结合使用。也可以用作勾选框。有关更多信息，请参见 CDASH IG 第 3.7 节。 |
| Events 事件 | N/A | 43 | --ONGO | Ongoing Event 持续事件 | An indication whether the event is ongoing as of a given timepoint when no End Date is provided. 一个指示，表明在未提供结束日期的情况下，事件在给定时间点是否正在进行。 | [Is/Was] the [--TERM/event topic] ongoing (as of [the study-specific timepoint or period])? [在研究特定时间点或期间]，该[--术语/事件主题]是否正在进行？ | Ongoing (as of the [Study-Specific Timepoint or Period]) 进行中（截至[研究特定时间点或期间]） | Char 字符 | --ENRTPT; --ENRF | This does not map directly to an SDTM variable. May be used to populate a value into an SDTM relative timing variable such as --ENRF or --ENRTPT. When populating --ENRF, or --ENRTPT, if the value of the CDASH field --ONGO is "Y" a value from the CDISC CT (STENRF) may be used. When --ONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable --ENRF should be populated. When --ONGO is compared to any other timepoint, the SDTM variables --ENRTPT and --ENTPT should be used. Note: --ENRTPT must refer to the "time point anchor" described in --ENTPT. 这并不直接映射到 SDTM 变量。可以用于填充 SDTM 相对时间变量，如--ENRF 或--ENRTPT。当填充--ENRF 或--ENRTPT 时，如果 CDASH 字段--ONGO 的值为“Y”，则可以使用 CDISC CT 中的值（STENRF）。当--ONGO 指的是研究参考期（在 DM.RFSTDTC 到 DM.RFENDTC 中定义）时，应填充 SDTM 变量--ENRF。当--ONGO 与任何其他时间点进行比较时，应使用 SDTM 变量--ENRTPT 和--ENTPT。注意：--ENRTPT 必须指代--ENTPT 中描述的“时间点锚”。 | (NY) （纽约） | The CDASH field --ONGO allows specific question text/prompt about events ending prior to the given timepoint. Select the appropriate text when designing the CRF. This may also included in the CRF title or instructions. Used in conjunction with either a reference timepoint (--ENTPT, --ENRTPT) or in conjunction with the Study Reference Period (described as RFSTDTC to RFENDTC). May also be used as a tick/checkbox. See the CDASH IG Section 3.7 for more information. CDASH 字段--ONGO 允许针对在给定时间点之前结束的事件提出特定的问题文本/提示。在设计 CRF 时选择适当的文本。这也可以包含在 CRF 标题或说明中。与参考时间点（--ENTPT，--ENRTPT）或研究参考期间（描述为 RFSTDTC 到 RFENDTC）一起使用。也可以用作勾选框。有关更多信息，请参见 CDASH IG 第 3.7 节。 |
| Events 事件 | N/A | 44 | --DIS | Caused Study Discontinuation 导致研究中断 | An indication whether the event caused the subject to discontinue from the study. 事件是否导致受试者中断研究的指示。 | Did the [--TERM/event topic] cause the subject to be discontinued from the study? 该[--TERM/事件主题]是否导致该受试者退出研究？ | Caused Study Discontinuation 导致研究中断 | Char 字符 | SUPP--.QVAL | Does not map to an SDTM variable. For the SDTM submission datasets, may be used to create a RELREC to link the Event to the Disposition record. 不映射到 SDTM 变量。对于 SDTM 提交数据集，可以用于创建 RELREC，将事件链接到处置记录。 | (NY) （纽约） | May be used to create a RELREC to link the record to a Disposition record. See section 8.2 in the SDTMIG V3.2 for information on RELREC. The sponsor could submit "--DIS" in a SUPP-- dataset as a value of SUPP--.QVAL where SUPP--.QNAM is "--DIS" and SUPP--.QLABEL is "Caused Study Discontinuation", if appropriate. 可以用于创建一个 RELREC，将记录链接到处置记录。有关 RELREC 的信息，请参见 SDTMIG V3.2 中的第 8.2 节。如果适用，赞助商可以在 SUPP--数据集中提交“--DIS”作为 SUPP--.QVAL 的值，其中 SUPP--.QNAM 为“--DIS”，SUPP--.QLABEL 为“导致研究中断”。 |
| Events 事件 | N/A | 45 | --CTRL | Disease or Symptom Under Control 疾病或症状得到控制 | An indication that the disease/symptoms are under control at the time of data collection. 在数据收集时，疾病/症状处于控制状态的指示。 | [Is/Was] the [--TERM/event topic] under control? [--TERM/事件主题]是否在控制之下？ | [ --TERM/Event Topic ] Under Control 在控制之下 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM is "--CTRL" and SUPP--.QLABEL is "Disease or Symptom Under Control". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM 为"--CTRL"，SUPP--.QLABEL 为"控制下的疾病或症状"。有关在 SDTM 领域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | (NY) （纽约） | The conditions would typically be defined in the protocol. For example, a sponsor may ask the site to indicate whether the subject's hypertension is under control at enrollment into the study. 这些条件通常会在方案中定义。例如，赞助商可能会要求研究地点指明受试者在入组时高血压是否得到控制。 |
| Events 事件 | N/A | 46 | --REAS | Reason for the Event 事件原因 | A description of the reason for the event. 事件发生原因的描述。 | What [is/was] the reason (for the [--TERM/event topic])? [--TERM/事件主题]的原因是什么？ | Reason for the [--TERM/Event Topic] [--TERM/事件主题]的原因 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM is "--REAS" and SUPP--.QLABEL is "Reason for the Event". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM 为"--REAS"，SUPP--.QLABEL 为"事件原因"。有关在 SDTM 领域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | N/A | To ensure data quality, it is recommended that the sponsor develop controlled terminology. Reason for Health Care Encounters could include LACK OF EFFICACY, ADVERSE EVENT, CHEMOTHERAPY, PHYSICAL THERAPY, INDICATION UNDER STUDY, NOT INDICATION UNDER STUDY. 为了确保数据质量，建议赞助方制定受控术语。医疗接触的原因可能包括疗效不足、不良事件、化疗、物理治疗、研究中的适应症、非研究中的适应症。 |
| Events 事件 | N/A | 47 | COVAL | [domain specific label] [领域特定标签] | A free text comment. 免费文本评论。 | [Protocol -specified Targeted Question]? [协议指定的针对性问题]? | [abbreviated version of the protocol-specified targeted question] [协议规定的目标问题的简化版本] | Char 字符 | CO.COVAL | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable --COVAL maps to the SDTM variable COVAL (COVAL2, COVAL3) in the CO domain. Associate the free text comment in the CO domain with the original record using RDOMAIN, IDVAR, IDVARVAL, COREF. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量--COVAL 映射到 CO 领域中的 SDTM 变量 COVAL（COVAL2，COVAL3）。使用 RDOMAIN、IDVAR、IDVARVAL、COREF 将 CO 领域中的自由文本评论与原始记录关联起来。 | N/A | If an additional free text field is needed to provide a comment about a particular record, use the COVAL(n) field to collect the free text, and associate the free text comment with the original record using SDTM variables RDOMAIN, IDVAR, IDVARVAL, COREF. See the SDTMIG for more information. 如果需要额外的自由文本字段来提供关于特定记录的评论，请使用 COVAL(n) 字段收集自由文本，并使用 SDTM 变量 RDOMAIN、IDVAR、IDVARVAL、COREF 将自由文本评论与原始记录关联。有关更多信息，请参见 SDTMIG。 |
| Events 事件 | N/A | 52 | --MODIFY | Modified Term 修改后的术语 | If the value for --TERM is modified for coding purposes, then the modified text is placed here. 如果为了编码目的修改了 --TERM 的值，则修改后的文本放在这里。 | N/A | N/A | Char 字符 | --MODIFY | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 53 | --LLT | Lowest Level Term 最低级术语 | MedDRA Dictionary text description of the Lowest Level Term. MedDRA 字典中最低级别术语的文本描述。 | N/A | N/A | Char 字符 | --LLT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 54 | --LLTCD | Lowest Level Term Code 最低级别术语代码 | MedDRA Dictionary Lowest Level Term code. MedDRA 字典最低级别术语代码。 | N/A | N/A | Num 数字 | --LLTCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 55 | --PTCD | Preferred Term Code 首选术语代码 | MedDRA Dictionary code for the Preferred Term. MedDRA 字典代码用于首选术语。 | N/A | N/A | Num 数字 | --PTCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata to indicate that the data was "ASSIGNED". 直接映射到标题为“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据中包含一个来源，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 56 | --SOC | Primary System Organ Class 主要系统器官分类 | MedDRA Primary System Organ Class description associated with the event. 与事件相关的 MedDRA 主要系统器官分类描述。 | N/A | N/A | Char 字符 | --SOC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 57 | --SOCCD | Primary System Organ Class Code 主要系统器官分类代码 | MedDRA primary System Organ Class code. MedDRA 主要系统器官分类代码。 | N/A | N/A | Num 数字 | --SOCCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。这适用于使用 MedDRA 编码字典的项目。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 58 | --HLT | High Level Term 高级术语 | MedDRA Dictionary text description of the High Level Term from the primary path. MedDRA 字典中关于主要路径的高层术语的文本描述。 | N/A | N/A | Char 字符 | --HLT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 59 | --HLTCD | High Level Term Code 高级术语代码 | MedDRA Dictionary High Level Term code from the primary path. MedDRA 字典高层术语代码来自主要路径。 | N/A | N/A | Num 数字 | --HLTCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 60 | --HLGT | High Level Group Term 高级小组术语 | MedDRA Dictionary text description of the High Level Group Term from the primary path. MedDRA 字典中关于主要路径的高层组术语的文本描述。 | N/A | N/A | Char 字符 | --HLGT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Events 事件 | N/A | 61 | --HLGTCD | High Level Group Term Code 高级组别术语代码 | MedDRA Dictionary High Level Group Term code from the primary path. MedDRA 字典高层组术语代码来自主要路径。 | N/A | N/A | Num 数字 | --HLGTCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The sponsor is expected to provide the dictionary name and version used to code the event utilizing the Define-XML external codelist attributes. Sponsors should include an Origin column in the define metadata document to indicate that the data was "ASSIGNED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。赞助商应提供用于编码事件的字典名称和版本，利用 Define-XML 外部代码列表属性。赞助商应在定义元数据文档中包含一个来源列，以指示数据是“分配的”。 | N/A | This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This variable is applicable when using the MedDRA coding dictionary. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 该字段通常不会出现在 CRF 上。赞助商将通过编码过程填充此字段。当使用 MedDRA 编码字典时，此变量适用。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
2.3 Findings 2.3 发现
Findings 发现
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Findings 发现 | FA | 1 | --OBJ | Object of the Observation 观察对象 | Describes the event or intervention whose property is being measured in --TESTCD/--TEST. 描述正在测量其属性的事件或干预措施 --TESTCD/--TEST。 | N/A | N/A | Char 字符 | --OBJ | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | The --OBJ will usually be pre-printed or hidden, and not solicited as an actual question. These FA domains are usually created by each sponsor. CDASH has used this variable in the SR domain. --OBJ 通常会预先打印或隐藏，并不会作为实际问题被提出。这些 FA 领域通常由每个赞助商创建。CDASH 在 SR 领域中使用了这个变量。 |
| Findings 发现 | N/A | 1 | --YN | Any [Finding] 任何[发现] | An indication whether or not any data was collected for the finding topic. 是否收集了与发现主题相关的任何数据的指示。 | Has the subject had any [Findings topic(s)] (after/before [study specific time frame]) ?; [Was/Were] (there) any [Findings topic(s)] (reported) (after/before [study specific time frame])?; Were all eligibility criteria met? 受试者在[研究特定时间范围]之前/之后是否有任何[发现主题]？在[研究特定时间范围]之前/之后是否有任何[发现主题]（报告）？所有资格标准是否都满足？ | Any [Finding Topic] 任何[发现主题] | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | This is a field that can be used in any CRF to indicate whether or not there is data to record. Used primarily as a data cleaning field. This provides verification that all other fields on the CRF were deliberately left blank. For example, this is used in the 1) DD domain to indicate no information on any death details are being provided, 2) IE domain to indicate whether the subject met all the eligibility requirements for this study at the time the subject was enrolled. --PERF should be used to capture a response about whether planned measurements, tests, observations were done. 这是一个可以在任何 CRF 中使用的字段，用于指示是否有数据需要记录。主要用作数据清理字段。这提供了验证，确保 CRF 上的所有其他字段都是故意留空的。例如，这在 1) DD 领域中用于指示没有提供任何死亡细节的信息，2) IE 领域中用于指示受试者在注册时是否满足本研究的所有资格要求。--PERF 应用于捕捉关于计划的测量、测试、观察是否已完成的响应。 |
| Findings 发现 | N/A | 2 | --PERF | [Observation] Performed [观察] 已执行 | An indication whether or not a planned measurement, test, observation or specimen was performed/collected. 指示计划的测量、测试、观察或样本是否已执行/收集。 | [Were any/Was the] [--TEST/topic] ([measurement(s)/test(s)/examination(s)/specimen(s)/sample(s)]) [performed/collected]? [是否进行了] [--测试/主题] ([测量/测试/检查/标本/样本]) [执行/收集]? | ([--TEST/ topic] ([Measurement (s)/Test(s)/Examination(s)/Specimen(s)/Sample(s) ]) [Performed/Collected]? ([--测试/主题] ([测量（秒）/测试/检查/标本/样本]) [执行/收集]？ | Char 字符 | --STAT | This field does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable --STAT. If the CDASH variable --PERF="N", the value of the STDM variable --STAT is "NOT DONE". If --PERF= "Y", --STAT is null. A combination of SDTM variables (e.g., --CAT and --SCAT, --TPT ) is used to indicate that multiple tests were not done. In this situation, the SDTM variable --TESTCD would be populated with --ALL and an appropriate test name (--TEST) provided. See SDTMIG for the section on "Tests Not Done". 该字段不直接映射到 SDTM 变量。可用于填充 SDTM 变量--STAT 的值。如果 CDASH 变量--PERF="N"，则 SDTM 变量--STAT 的值为"NOT DONE"。如果--PERF="Y"，则--STAT 为空。使用 SDTM 变量的组合（例如，--CAT 和--SCAT，--TPT）来表示多个测试未完成。在这种情况下，SDTM 变量--TESTCD 将填充为--ALL，并提供适当的测试名称（--TEST）。有关“未完成的测试”的部分，请参见 SDTMIG。 | (NY) （纽约） | This field is used to capture a response to whether or not a planned measurement, test or observation was performed. A negative response can be collected as "N" and mapped to the –STAT variable in SDTM as "NOT DONE". 该字段用于记录计划的测量、测试或观察是否已执行的响应。负面响应可以收集为“N”，并映射到 SDTM 中的–STAT 变量为“NOT DONE”。 |
| Findings 发现 | N/A | 3 | --TESTCD | Short Name of Measurement, Test or Examination 测量、测试或检查的简称 | Short character value code for the test being performed. 正在执行的测试的短字符值代码。 | N/A | N/A | Char 字符 | --TESTCD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The SDTM variable --TESTCD may be determined from the value collected in --TEST. The SDTMIG variables --TESTCD and --TEST are required in SDTM. 直接映射到标题为“SDTM 目标”列中列出的 SDTM 变量。SDTM 变量--TESTCD 可以从收集到的--TEST 值中确定。SDTMIG 变量--TESTCD 和--TEST 在 SDTM 中是必需的。 | (--TESTCD) (--测试代码) | May be used as a column name when converting from a vertical dataset format to a horizontal dataset format. --TESTCD is most useful as a variable name, or variable naming fragment (e.g., [ --TESTCD_--ORRES] for the clinical database or EDC system for the field in which the result is collected for that test. The short value can be up to 8 characters. The domain-specific --TESTCD codelists names (e.g. EGTESTCD, FATESTCD) are provided in the CDASHIG Metadata Table. 可以在将垂直数据集格式转换为水平数据集格式时用作列名。--TESTCD 最适合作为变量名或变量命名片段（例如，[ --TESTCD_--ORRES] 用于临床数据库或 EDC 系统中收集该测试结果的字段）。短值可以最多为 8 个字符。特定领域的 --TESTCD 代码列表名称（例如 EGTESTCD、FATESTCD）在 CDASHIG 元数据表中提供。 |
| Findings 发现 | N/A | 4 | --TEST | Name of Measurement, Test or Examination 测量、测试或检查的名称 | Descriptive name for the test being performed. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination. 测试的描述性名称。示例：血小板，收缩压，摘要（分钟）RR 持续时间，眼科检查。 | What [is/was] the name (of the [measurement/test/examination])? [测量/测试/检查]的名称是什么？ | [Measurement/Test/Examination/] (Name) [测量/测试/检查/] (名称) | Char 字符 | --TEST | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". The SDTM variable --TESTCD may be determined from the value collected in --TEST. The SDTMIG variables --TESTCD and --TEST are required in SDTM. 直接映射到标题为“SDTM 目标”列中列出的 SDTM 变量。SDTM 变量--TESTCD 可以从收集到的--TEST 值中确定。SDTMIG 变量--TESTCD 和--TEST 在 SDTM 中是必需的。 | (--TEST) (--测试) | The test name will usually be pre-printed on the CRF, and not solicited as a question. If the form is laid out as a grid, then words such as Test or Test Name can be included as the column header. --TEST is most useful as the PROMPT on the field in which the RESULT for that test is collected. The domain-specific TEST codelists names (e.g. EGTEST, FATEST ) are provided in the CDASHIG Metadata Table. 测试名称通常会预先印刷在 CRF 上，而不是作为问题提出。如果表格以网格形式布局，则可以将“测试”或“测试名称”等词作为列标题。--TEST 在收集该测试结果的字段中作为提示最为有用。特定领域的测试代码列表名称（例如 EGTEST，FATEST）在 CDASHIG 元数据表中提供。 |
| Findings 发现 | N/A | 5 | --TSTDTL | Measurement, Test or Examination Detail 测量、测试或检查详情 | A further description of --TESTCD and --TEST. 对--TESTCD 和--TEST 的进一步描述。 | What [is/was] the [measurement/test/examination] detail name? 测量/测试/检查的详细名称是什么？ | [Measurement/Test/Examination] Detail (Name) [测量/测试/检查] 详情（名称） | Char 字符 | --TSTDTL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | It is recommended that the test detail name be pre-printed on the CRF. If the form is laid out as a grid, then words such as Test, Test Name can be included as the column header. 建议在 CRF 上预先打印测试详细名称。如果表格布局为网格，则可以将“测试”、“测试名称”等词作为列标题。 |
| Findings 发现 | N/A | 6 | --CAT | Category 类别 | A grouping of topic-variable values based on user-defined characteristics. 基于用户定义特征的主题变量值分组。 | What [is/was] the [type/category/name] (of the [measurement/test/examination/specimen/sample])? 该[测量/测试/检查/样本]的[类型/类别/名称]是什么？ | [Category/Category Value]; NULL [类别/类别值]; NULL | Char 字符 | --CAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. Note: CDISC Controlled terminology (IECAT) is used for the IE domain. 赞助商定义的受控术语。这通常是在 CRF 或屏幕上的标题，而不是站点提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。如果提出问题，回答通常是赞助商定义的代码列表。如果表格以网格形式布局，则可以将“类别”等词作为列标题。示例在 CDASHIG 元数据表或 SDTMIG 中提供。注意：CDISC 受控术语（IECAT）用于 IE 领域。 |
| Findings 发现 | N/A | 7 | --SCAT | Subcategory 子类别 | A sub-division of the --CAT values based on user-defined characteristics. 基于用户定义特征的--CAT 值的子划分。 | What [is/was] the [type/subcategory/name] (of the [measurement/test/examination/specimen/sample])? 该[测量/测试/检查/样本]的[类型/子类别/名称]是什么？ | [(Domain Name/Name) Subcategory]; NULL [(域名/名称) 子类别]; NULL | Char 字符 | --SCAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header. --SCAT can only be used if there is a --CAT. Examples are provided in the CDASHIG Metadata Table or in the SDTMIG. 赞助商定义的受控术语。这通常是在 CRF 或屏幕上的标题，而不是站点提供答案的问题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。如果提出问题，回答通常是赞助商定义的代码列表。如果表格以网格形式布局，则可以将“子类别”等词作为列标题。--SCAT 只能在有--CAT 的情况下使用。示例在 CDASHIG 元数据表或 SDTMIG 中提供。 |
| Findings 发现 | N/A | 8 | --ORRES | Result of Finding in Original Unit 原单位的查找结果 | Result of the measurement or finding as originally received or collected. 测量或发现的结果，按原样接收或收集。 | What [is/was] the [result/amount/(subject's) characteristic] (of the [measurement/test/examination/question/assessment])? 测量/测试/检查/问题/评估的结果是什么？ | ([Result/Amount] of) [value from --TEST] ([结果/金额] 为) [来自 --TEST 的值] | Char 字符 | --ORRES | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | In most cases, the Question Text and Item Prompt for the --ORRES are specific to the --TEST. The value of --TEST is most useful as the PROMPT on the field in which the RESULT for that test is collected. If the form is laid out as a grid, then words such as "Result" can be included as the column header. On CRFs used for the drug accountability, the prompt and question text can reflect that the "amount" of study drug dispensed/returned is collected rather than a result. 在大多数情况下，--ORRES 的问题文本和项目提示是特定于 --TEST 的。--TEST 的值在收集该测试结果的字段中作为提示最为有用。如果表单布局为网格，则可以将“结果”等词作为列标题包含在内。在用于药物责任的 CRF 中，提示和问题文本可以反映收集的是分发/退回的研究药物的“数量”，而不是结果。 |
| Findings 发现 | N/A | 9 | --ORRESU | Original Unit 原始单位 | The unit of the result as originally received or collected. 结果的单位，如最初接收或收集的。 | What [is/was] the unit (of the [measurement/test/examination])? 该（测量/测试/检查）的单位是什么？ | Unit 单位 | Char 字符 | --ORRESU | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (UNIT) （单位） | The Question Text and Item Prompt for the --ORRESU may be specific to the --TEST. Should be pre-printed on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. Note: CDISC Controlled Terminology (PKUNIT) is used for the SDTMIG PP domain, and (VSRESU) is used for the VS domain. --ORRESU 的问题文本和项目提示可能特定于 --TEST。应尽可能在 CRF 上预先打印与相关测试相关的内容，而不是收集需要现场输入文本的字段。注意：CDISC 控制术语（PKUNIT）用于 SDTMIG PP 领域，(VSRESU) 用于 VS 领域。 |
| Findings 发现 | N/A | 10 | --DESC | Description of Finding 发现描述 | Text description of any findings. 文本描述任何发现。 | What [is/was] the [result/amount] (of the [measurement/test/examination])?; [Is/Was] the result [normal/abnormal/absent/present/ sponsored defined response]? 结果是什么（测量/测试/检查的结果）？结果是正常/异常/缺失/存在/赞助定义的反应吗？ | (Abnormal) Findings （异常）发现 | Char 字符 | --ORRES | This does not map directly to an SDTM variable. For the SDTM submission dataset, if the CDASH field -- RES = "NORMAL", populate the SDTM variables --ORRES and --STRESC with the value of the CDASH field --RES. If the value of the CDASH field --RES is "ABNORMAL", populate the SDTM variable --ORRES with the CDASH field --DESC. If the reported findings in --DESC are coded using a dictionary, then the SDTM variable --STRESC is populated with the dictionary preferred term and --MODIFY is populated with the modified text used for coding. If the reported findings in --DESC are not coded, then the SDTM variable --STRESC is populated with the CDASH --DESC field. The SDTM variable, --NRIND, may be populated with "NORMAL" or "ABNORMAL" if appropriate. 这与 SDTM 变量没有直接对应关系。对于 SDTM 提交数据集，如果 CDASH 字段--RES = "正常"，则将 SDTM 变量--ORRES 和--STRESC 填入 CDASH 字段--RES 的值。如果 CDASH 字段--RES 的值为"异常"，则将 SDTM 变量--ORRES 填入 CDASH 字段--DESC。如果--DESC 中报告的发现使用字典编码，则 SDTM 变量--STRESC 填入字典首选术语，--MODIFY 填入用于编码的修改文本。如果--DESC 中报告的发现未编码，则 SDTM 变量--STRESC 填入 CDASH--DESC 字段。SDTM 变量--NRIND 可以适当填入"正常"或"异常"。 | N/A | The original standard result (e.g., Normal/Abnormal ) is collected using the CDASH field --RES and the abnormal finding is collected using the CDASH field --DESC. 原始标准结果（例如，正常/异常）使用 CDASH 字段--RES 收集，异常发现使用 CDASH 字段--DESC 收集。 |
| Findings 发现 | N/A | 11 | --RES | Collected Result or Finding 收集的结果或发现 | The result of the measurement or finding as originally received or collected. 测量或发现的结果，按原样接收或收集。 | What [is/was] the [result/amount] (of the [measurement/test/examination])?; [Is/Was] the result [normal/abnormal/absent/present/ sponsored defined response]? 结果是什么（测量/测试/检查的结果）？结果是正常/异常/缺失/存在/赞助定义的反应吗？ | ([Result/Amount] of) [value from --TEST] ([结果/金额] 为) [来自 --TEST 的值] | Char 字符 | --ORRES | This does not map directly to an SDTM variable. The mapping instructions depend on the implementation. Case 1: Used to collect Normal, Abnormal (or other similar type classifications- Absent Present) with a description of the abnormal result using the CDASH field --DESC. For SDTM submission datasets, If the CDASH field --RES = "NORMAL", populate the SDTM variables --ORRES and --STRESC with the value of the CDASH field --RES. If the CDASH field --RES is "ABNORMAL", populate the SDTM variable --ORRES with the CDASH field --DESC. If the reported findings in --DESC are coded using a dictionary, then the SDTM variable --STRESC is populated with the dictionary preferred term and --MODIFY is populated with the modified text used for coding. If the reported findings in --DESC are not coded, then the SDTM variable --STRESC is populated with the CDASH --DESC field. The SDTM variable, --NRIND may be populated with "NORMAL" or "ABNORMAL" if appropriate. Case 2: Where --RES is used to collect standardized values (e.g. a code list) on the CRF and the value of "OTHER" is included, the CDASH field --RESOTH can be used to collect free text values for "Specify Other". When using this field, the "OTHER" value recorded in the CDASH field --RES field is mapped to the SDTM variable --STRESC and the value in the CDASH field --RESOTH is mapped to the SDTM variable --ORRES. See section 4.1.2.7.2 in the SDTMIG. 这并不直接映射到 SDTM 变量。映射指令取决于实施情况。案例 1：用于收集正常、异常（或其他类似类型分类-缺失、存在）并使用 CDASH 字段--DESC 描述异常结果。对于 SDTM 提交数据集，如果 CDASH 字段--RES = "NORMAL"，则将 SDTM 变量--ORRES 和--STRESC 填充为 CDASH 字段--RES 的值。如果 CDASH 字段--RES 为"ABNORMAL"，则将 SDTM 变量--ORRES 填充为 CDASH 字段--DESC。如果--DESC 中报告的发现使用字典编码，则 SDTM 变量--STRESC 填充为字典首选术语，--MODIFY 填充为用于编码的修改文本。如果--DESC 中报告的发现未编码，则 SDTM 变量--STRESC 填充为 CDASH--DESC 字段。SDTM 变量--NRIND 可以适当填充为"正常"或"异常"。案例 2：当--RES 用于在 CRF 上收集标准化值（例如，代码列表）并包含"其他"值时，可以使用 CDASH 字段--RESOTH 收集"指定其他"的自由文本值。 在使用此字段时，CDASH 字段中的“OTHER”值记录在--RES 字段中，映射到 SDTM 变量--STRESC，而 CDASH 字段中的--RESOTH 值映射到 SDTM 变量--ORRES。请参见 SDTMIG 中的 4.1.2.7.2 节。 | N/A | The CDASH field --RES is used when the collected results are not mapped directly to the SDTM variable --ORRES and must be mapped. For example, 1) --RES is used to collect standardized values on the CRF and the value of "OTHER" is included and Specify Other is collected, 2) --RES is collected using Normal, Abnormal and a description of the abnormality is collected. CDASH 字段--RES 用于当收集的结果未直接映射到 SDTM 变量--ORRES 时，必须进行映射。例如，1) --RES 用于在 CRF 上收集标准化值，并且包括“其他”值，并收集指定其他，2) --RES 使用正常、异常收集，并收集异常的描述。 |
| Findings 发现 | N/A | 12 | --RESOTH | Result Other 结果 其他 | A free text result which provides further information about the original received or collected result. 一个免费的文本结果，提供有关原始接收或收集结果的进一步信息。 | If other is selected, [explain/specify/provide more detail]? 如果选择了其他，请[解释/说明/提供更多细节]？ | [Specify Other/Explain/Specify Details [Treatment/Intervention] [指定其他/解释/指定细节 [治疗/干预]] | Char 字符 | --ORRES | When using this CDASH field, the "OTHER" value collected in the CDASH field --RES is mapped to the SDTM variable --STRESC and the value in the CDASH field --RESOTH is mapped to the SDTM variable --ORRES. See section 4.1.2.7.2 in the SDTMIG. 在使用此 CDASH 字段时，CDASH 字段中的“其他”值--RES 被映射到 SDTM 变量--STRESC，而 CDASH 字段中的值--RESOTH 被映射到 SDTM 变量--ORRES。请参见 SDTMIG 中的第 4.1.2.7.2 节。 | N/A | In a case where --RES is used to collect standardized values on the CRF and the value of "OTHER" is included, the CDASH field --RESOTH can be used to collect free text values for "Specify Other". 在使用 --RES 收集 CRF 上的标准化值且包含“其他”值的情况下，可以使用 CDASH 字段 --RESOTH 收集“指定其他”的自由文本值。 |
| Findings 发现 | N/A | 13 | --RESCAT | Result Category 结果类别 | A categorization of the result of a finding. 发现结果的分类。 | What [is/was] the result category (of the [measurement/test/examination])? 结果类别是什么（测量/测试/检查的）？ | [--TEST] Result Category [--测试] 结果类别 | Char 字符 | --RESCAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation. Note: CDISC Controlled terminology (MSRESCAT) is used for the MS domain. 赞助商定义的受控术语。示例：肿瘤发现的恶性或良性。遗传变异的抗性变异。注意：MS 领域使用 CDISC 受控术语（MSRESCAT）。 |
| Findings 发现 | N/A | 14 | --ORNRLO | Normal Range Lower Limit- Original Unit 正常范围下限 - 原始单位 | The lower end of normal range or reference range for continuous results stored in --ORRES. 正常范围或参考范围的下限用于存储在 --ORRES 中的连续结果。 | What [is/was] the lower limit of the reference range (for the [measurement/test/examination])? 该（测量/测试/检查）的参考范围下限是多少？ | Normal Range Lower Limit 正常范围下限 | Char 字符 | --ORNRLO | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | --ORNRLO should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. --ORNRLO 仅应针对连续发现进行填充。SDTM 变量 --STNRC 仅应针对非连续结果进行填充。这些数据可以从实验室或电子设备获取。这些数据可以从存储在查找表中的特定于站点或实验室的正常范围集派生。 |
| Findings 发现 | N/A | 15 | --ORNRHI | Normal Range Upper Limit- Original Unit 正常范围上限 - 原始单位 | The upper end of normal range or reference range for continuous results stored in --ORRES. 正常范围或参考范围的上限用于存储在 --ORRES 中的连续结果。 | What [is/was] the upper limit of the reference range (for the [measurement/test/examination])? 该[测量/测试/检查]的参考范围上限是多少？ | Normal Range Upper Limit 正常范围上限 | Char 字符 | --ORNRHI | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | --ORNRHI should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. --ORNRHI 仅应为连续发现填充。SDTM 变量 --STNRC 仅应为非连续结果填充。这些数据可以从实验室或电子设备获取。这些数据可以从存储在查找表中的特定于站点或实验室的正常范围集派生。 |
| Findings 发现 | N/A | 16 | --CSTNRC | Collected Character/Ordinal Normal Range 收集的字符/序数正常范围 | The normal references ranges that are expressed as characters ("Negative to Trace" ) or ordinal (-1 to 1). 正常参考范围以字符（“阴性到微量”）或序数（-1 到 1）表示。 | What [is/was] the normal reference range (for this [measurement/test/examination])? 该（测量/测试/检查）的正常参考范围是什么？ | Normal Reference Range 正常参考范围 | Char 字符 | --STNRC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Should be populated for normal ranges that are reported as character in ordinal scale or if categorical ranges were supplied. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. 应填入正常范围，这些范围以序数尺度的字符形式报告，或如果提供了分类范围。这些数据可以从实验室或电子设备获取。这些数据可以来自特定地点或实验室的正常范围集合，这些集合存储在查找表中。 |
| Findings 发现 | N/A | 17 | --NRIND | Normal/Reference Range Indicator 正常/参考范围指示器 | An indication or description about how the value compares to the normal range or reference range. 关于该值与正常范围或参考范围的比较或描述。 | How [did/do] the reported values compare within the [reference/normal/expected] range? 报告的数值在[参考/正常/预期]范围内如何比较？ | Comparison to [Reference/Expected/Normal] Range 与[参考/预期/正常]范围的比较 | Char 字符 | --NRIND | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NRIND) | Reference ranges may be defined by --ORNRLO, --ORNRHI, --STNRC or other objective criteria. Reference Range Indicator (e.g., Y, N; HIGH, LOW; NORMAL; ABNORMAL) may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance. Should not be used to indicate clinical significance. 参考范围可以通过 --ORNRLO、--ORNRHI、--STNRC 或其他客观标准来定义。如果在数据收集后未通过程序计算或确定，可以包含参考范围指示符（例如，Y、N；高、低；正常；异常）。不应用于指示临床意义。 |
| Findings 发现 | N/A | 18 | --STAT | Completion Status 完成状态 | The variable used to indicate that data are not available by having the site recording the value as "Not Done". 用于指示数据不可用的变量，通过将站点记录的值设置为“未完成”来实现。 | Was the [--TEST ] not [completed/answered/done/assessed/evaluated ]?; Indicate if the ([--TEST] was) not [answered/assessed/done/evaluated/performed]. [--测试]是否未[完成/回答/进行/评估/评价]？; 指出([--测试]是否)未[回答/评估/进行/评价/执行]。 | Not Done 未完成 | Char 字符 | --STAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". If collected, the Origin (a column in the Define-XML) ="CRF", if populated from other sources such as a free text or sponsor-defined listing for --REASND, the Origin ="DERIVED". 直接映射到“SDTM 目标”列中列出的 SDTM 变量。如果收集，则 Origin（Define-XML 中的一列）=“CRF”；如果从其他来源填充，例如自由文本或赞助商定义的--REASND 列表，则 Origin=“DERIVED”。 | (ND) | Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the CDASH --PERF field. Typically a check box which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank. 仅在响应值被收集为未完成或空值时使用，作为 CDASH --PERF 字段的替代或补充。通常是一个复选框，表示测试未完成。当询问多个问题以确认空结果字段确实是空白时，此字段可能会很有用。 |
| Findings 发现 | N/A | 19 | --REASND | Reason Not Done 原因未完成 | An explanation of why the data are not available. 数据不可用的原因说明。 | Was the [is/was] the reason that the [Findings topic/data/information/sponsor-defined phrase] was not [collected/answered/done/assessed/evaluated]? 这是否是[研究主题/数据/信息/赞助商定义的短语]未被[收集/回答/完成/评估/评价]的原因？ | Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available] 原因未[回答/收集/完成/评估/评定/可用] | Char 字符 | --REASND | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor-defined Controlled Terminology may be used. The reason the data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused, etc.) or entered as free text. When --REASND is used, --STAT should also be populated in the SDTM-based dataset. 赞助商定义的受控术语可以使用。数据不可用的原因可以从赞助商定义的代码列表中选择（例如，设备故障、受试者拒绝等）或作为自由文本输入。当使用--REASND 时，--STAT 也应在基于 SDTM 的数据集中填充。 |
| Findings 发现 | N/A | 20 | --NAM | Laboratory/Vendor Name 实验室/供应商名称 | Name or identifier of the vendor (e.g., laboratory) that provided the test results. 提供测试结果的供应商（例如，实验室）的名称或标识符。 | What was the name of the [vendor] used? 使用的[供应商]的名称是什么？ | [Vendor Name] [供应商名称] | Char 字符 | --NAM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Recommended to collect on the CRF if vendor names was not collected at the site/study level or if multiple vendors are used by a site. 建议在 CRF 上收集，如果在现场/研究级别未收集供应商名称或如果一个站点使用多个供应商。 |
| Findings 发现 | N/A | 21 | --LOINC | LOINC Code LOINC 代码 | The Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test. 主题变量的逻辑观察标识符名称和代码（LOINC）代码，例如实验室测试。 | What [is/was] the LOINC code? LOINC 代码是什么？ | LOINC Code LOINC 代码 | Char 字符 | --LOINC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Findings 发现 | N/A | 22 | --SPEC | Specimen Type 标本类型 | The type of specimen used for a measurement. 用于测量的标本类型。 | What [is/was] the specimen type? 样本类型是什么？ | Specimen Type 标本类型 | Char 字符 | --SPEC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (SPECTYPE) （光谱类型） | N/A |
| Findings 发现 | N/A | 23 | --ANTREG | Anatomical Region 解剖区域 | The specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. 组织、器官标本的特定解剖或生物区域，或根据协议定义的获取标本的区域，例如--SPEC 变量中描述的部分或切片。 | What [is/was] the anatomical or biological region (of the [organ specimen/tissue] )? 该[器官标本/组织]的解剖或生物区域是什么？ | [Specimen/Organ/Tissue] Anatomical Region [标本/器官/组织] 解剖区域 | Char 字符 | --ANTREG | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | The SDTM variable --ANTREG is defined as a variable qualifier of the SDTM variable --SPEC. SDTM 变量--ANTREG 被定义为 SDTM 变量--SPEC 的变量限定符。 |
| Findings 发现 | N/A | 24 | --SPCCND | Specimen Condition 标本状态 | The condition of the specimen. 标本的状态。 | What [is/was] the condition of the specimen? 样本的状态是什么？ | Specimen Condition 标本状态 | Char 字符 | --SPCCND | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (SPECCOND) | Standardized text describing the condition of the sample (e.g., Hemolyzed, Lipemic). 标准化文本描述样本的状态（例如，溶血、脂肪性）。 |
| Findings 发现 | N/A | 25 | --CSPUFL | Collected Specimen Usability Flag 收集的标本可用性标志 | An indication about the usability of the specimen for obtaining the test result. 关于样本在获取测试结果方面可用性的指示。 | What is/was the usability (of this specimen)?; [Is/Was] the specimen usable? 这个样本的可用性是什么/曾经是什么？这个样本可用吗？ | Specimen Usability 样本可用性 | Char 字符 | --SPCUFL | This does not map directly to an SDTM variable. For the SDTM dataset, if the CDASH variable --CSPUFL= "Y", the value of the STDM variable --CSPUFL is "Y". If CSPULF= "N", --CSPULF is null. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，如果 CDASH 变量--CSPUFL="Y"，则 STDM 变量--CSPUFL 的值为"Y"。如果 CSPULF="N"，则--CSPULF 为 null。 | (NY) （纽约） | N/A |
| Findings 发现 | N/A | 26 | --POS | Position of Subject During Observation 观察期间的主体位置 | The position of the subject during a measurement or examination. 测量或检查期间受试者的位置。 | In what position was the subject during the [measurement/ test/examination/specimen collection/sample collection]?; What was the position of the subject (during the [measurement/test/examination/specimen collection/sample collection])? 在[测量/测试/检查/样本采集]期间，受试者处于什么位置？受试者在[测量/测试/检查/样本采集]期间的位置是什么？ | Position 位置 | Char 字符 | --POS | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (POSITION) (职位) | Note: CDISC Controlled Terminology (VSPOS) is used in the VS domain. 注意：CDISC 控制术语 (VSPOS) 在 VS 领域中使用。 |
| Findings 发现 | N/A | 27 | --LOC | Location 位置 | The anatomical location of the subject relevant to the collection of the measurement. 受试者的解剖位置与测量的收集相关。 | What [is/was] the anatomical location (of the [measurement/test/examination]) or What [is/was] the anatomical location where the [measurement/specimen] was taken/collected )? 该[测量/测试/检查]的解剖位置是什么？或者该[测量/标本]采集的解剖位置是什么？ | Anatomical Location 解剖位置 | Char 字符 | --LOC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LOC) (地点) | This may be pre-printed or collected. --LOC is used only to specify the anatomical location. --LAT, --DIR, --PORTOT are used to further describe the anatomical location. 这可以是预先打印的或收集的。--LOC 仅用于指定解剖位置。--LAT、--DIR、--PORTOT 用于进一步描述解剖位置。 |
| Findings 发现 | N/A | 28 | --LAT | Laterality 侧向性 | Qualifier for anatomical location further detailing the side of the body. 解剖位置的限定词，进一步详细说明身体的侧面。 | What [ is/ was] the side (of the anatomical location of the [measurement/test/examination])? 该测量/测试/检查的解剖位置位于哪一侧？ | Side 侧面 | Char 字符 | --LAT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (LAT) | Further detailing the laterality of the location of the --TEST. This may be pre-printed or collected. 进一步详细说明--测试的位置的侧向性。这可以是预先打印的或收集的。 |
| Findings 发现 | N/A | 29 | --DIR | Directionality 方向性 | Qualifier further detailing the position of the anatomical location relative to the center of the body, organ, or specimen. 进一步说明解剖位置相对于身体、器官或标本中心的定性描述。 | What [is/was] the directionality (of the anatomical location of the [measurement/test/examination]) ? 该[测量/测试/检查]的解剖位置的方向性是什么？ | Directionality 方向性 | Char 字符 | --DIR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (DIR) | Further detailing the directionality of the location of the --TEST (e.g., ANTERIOR, LOWER, PROXIMAL). This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF. 进一步详细说明--TEST 的位置方向（例如，前部、下部、近端）。这可以是预先打印的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Findings 发现 | N/A | 30 | --PORTOT | Portion or Totality 部分或整体 | Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. 解剖位置的限定词进一步详细说明了分布，这意味着排列和分配。 | What [is/was] the portion or totality (of the anatomical location of the [measurement/test/examination]) ? 该（测量/测试/检查）的解剖位置的部分或整体是什么？ | Portion or Totality 部分或整体 | Char 字符 | --PORTOT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (PORTOT) （波尔图） | Further detailing the portion or totality of the location of the --TEST. This may be pre-printed or collected. 进一步详细说明 --TEST 的部分或整体位置。这可以是预先打印的或收集的。 |
| Findings 发现 | N/A | 31 | --METHOD | Method of Test or Examination 测试或检查方法 | The method of the test or examination. 测试或考试的方法。 | What was the method (used for the [measurement/test/examination])? 使用了什么方法（用于[测量/测试/检查]）？ | Method 方法 | Char 字符 | --METHOD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (METHOD) (方法) | Note: CDISC Controlled Terminology (EGMETHOD) is used in the EG domain. 注意：CDISC 控制术语（EGMETHOD）在 EG 领域中使用。 |
| Findings 发现 | N/A | 32 | --LEAD | Lead Identified to Collect Measurements 确定的负责人收集测量数据 | The lead or leads identified to capture the measurement for a test from an instrument. 用于从仪器捕获测试测量的引线或引线。 | What [is/was] the lead (used to measure [measurement/test/examination])? 测量（测量/测试/检查）中使用的铅是什么？ | Lead 铅 | Char 字符 | --LEAD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Note: CDISC Controlled Terminology (EGLEAD) is used in the EG domain. 注意：CDISC 控制术语（EGLEAD）在 EG 领域中使用。 |
| Findings 发现 | N/A | 33 | --CSTATE | Consciousness State 意识状态 | The consciousness state of the subject at the time of measurement. 测量时受试者的意识状态。 | What [is/was] the consciousness state of the subject (at the time of the [measurement/test/examination])? 被试在（测量/测试/检查）时的意识状态是什么？ | Consciousness State 意识状态 | Char 字符 | --CSTATE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Findings 发现 | N/A | 34 | --FAST | Fasting Status 禁食状态 | An indication that the subject has abstained from food/water for the specified amount of time. 表明受试者在指定时间内已禁食/禁水。 | [Is/Was] the subject fasting (prior to the [test being performed/sample being collected])? 受试者在进行[测试/采样]之前是否禁食？ | Fasting 禁食 | Char 字符 | --FAST | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | N/A |
| Findings 发现 | N/A | 35 | --EVAL | Evaluator 评估者 | The role of the person who provided the evaluation. 提供评估的人的角色。 | Who provided the (sponsor-defined phrase) information?; Who was the evaluator? 谁提供了（赞助商定义的短语）信息？谁是评估者？ | [Evaluator/Reporter] [评估者/报告者] | Char 字符 | --EVAL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (EVAL) | Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed, or collected. Sponsors may collect the data using a subset list of CT on the CRF. 仅用于主观结果（例如，由个人或团体分配）。可以是预印刷的或收集的。赞助商可以使用 CRF 上的 CT 子集列表收集数据。 |
| Findings 发现 | N/A | 36 | --EVALID | Evaluator Identifier 评估者标识符 | An identifier used to distinguish multiple evaluators with the same role recorded in --EVAL. 用于区分在--EVAL 中记录的具有相同角色的多个评估者的标识符。 | What [is/was] the identifier of the [evaluator name/reporter name] (providing the-sponsor-defined phrase- information)? [evaluator name/reporter name]的标识符是什么（提供赞助商定义的短语信息）？ | [Evaluator/Reporter] Identifier [评估者/报告者] 标识符 | Char 字符 | --EVALID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (MEDEVAL) （MEDEVAL） | N/A |
| Findings 发现 | N/A | 37 | --ACPTFL | Accepted Record Flag 接受的记录标志 | An indication that the evaluation is considered, by an independent assessor, to be the accepted or final evaluation. 一个独立评估者认为该评估是被接受的或最终的评估的指示。 | [Is/Was] this record considered to be the [accepted/final] evaluation? 这份记录是否被视为[接受的/最终的]评估？ | [Accepted/Final] Evaluation [接受/最终] 评估 | Char 字符 | --ACPTFL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | Used where more than one assessor provides an evaluation of a result or response. Typically a check box with the value of "Y" or "NULL" which indicates the evaluation was accepted. 用于多个评估者对结果或回应进行评估的场合。通常是一个复选框，值为“Y”或“NULL”，表示评估已被接受。 |
| Findings 发现 | N/A | 38 | --TOX | Toxicity 毒性 | The description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. 毒性描述由 --TOXGR 量化，例如 NCI CTCAE 简称。 | What [is/was] the description of the [NCI CTCAE/ scale name ] toxicity)? [NCI CTCAE/量表名称]毒性描述是什么？ | [NCI CTCAE/Scale Name ] Toxicity [NCI CTCAE/量表名称] 毒性 | Char 字符 | --TOX | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor may choose to not collect --TOX. If collected, sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. 赞助商可以选择不收集 --TOX。如果收集，赞助商应在 Define-XML 文档的赞助商评论栏中指定使用的量表和版本。 |
| Findings 发现 | N/A | 39 | --TOXGR | Toxicity Grade 毒性等级 | The toxicity grade using a standard toxicity scale (such as the NCI CTCAE). 使用标准毒性等级（如 NCI CTCAE）评估毒性等级。 | What [is/was] the [NCI CTCAE Toxicity/scale name] grade? [NCI CTCAE 毒性/量表名称]的等级是什么？ | [NCI CTCAE Toxicity/scale name] Grade [NCI CTCAE 毒性/等级名称] 级别 | Char 字符 | --TOXGR | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Sponsor may choose to not collect --TOXGR. If collected, sponsors should specify which scale and version is used in the Sponsor Comments column of the Define- XML document. Note: CDISC Controlled Terminology (TOXGRV3) or (TOXGRV4) may be used for this variable. 赞助商可以选择不收集 --TOXGR。如果收集，赞助商应在定义 XML 文档的赞助商评论栏中指定使用的量表和版本。注意：此变量可以使用 CDISC 控制术语 (TOXGRV3) 或 (TOXGRV4)。 |
| Findings 发现 | N/A | 40 | --SEV | Severity Finding 严重性发现 | The severity or intensity of a particular finding. 特定发现的严重性或强度。 | What [is/was] the severity (of the finding)? 发现的严重性如何？ | Severity 严重性 | Char 字符 | --SEV | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A |
| Findings 发现 | N/A | 41 | --DTHREL | Relationship to Death 与死亡的关系 | An indication of the relationship of a particular finding to the death of a subject. 特定发现与受试者死亡之间关系的指示。 | [Is/Was] this findings related to the death of the subject ? 这些发现与该受试者的死亡有关吗？ | Related to Death 与死亡相关 | Char 字符 | --DTHREL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | N/A |
| Findings 发现 | N/A | 42 | --CLLOQ | Collected Lower Limit of Quantitation 收集的定量下限 | The collected lower limit of quantitation for an assay, represented in text format or as a range, such as less than a specified numeric value. 所收集的定量下限，表示为文本格式或范围，例如小于指定的数值。 | What [is/was] the lower limit of quantitation (for the [measurement/test/examination]) ? 该（测量/测试/检查）的定量下限是多少？ | Lower Limit of Quantitation 定量下限 | Num 数字 | --LLOQ | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable, --CLLOQ maps to the SDTM variable --LLOQ. The units will be those used for --STRESU. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量--CLLOQ 映射到 SDTM 变量--LLOQ。单位将是用于--STRESU 的单位。 | N/A | These data may be obtained directly from the lab or the electronic equipment and not collected on the CRF. The units are those used for the SDTM variable --STRESU. This is not the lower limit of normal of the reference range for the test. The SDTM variable --LLOQ must be populated as a numeric. 这些数据可以直接从实验室或电子设备获取，而不是在 CRF 上收集。单位是用于 SDTM 变量--STRESU 的单位。这不是测试参考范围的正常下限。SDTM 变量--LLOQ 必须以数字形式填写。 |
| Findings 发现 | N/A | 43 | --CULOQ | Collected Upper Limit of Quantitation 收集的定量上限 | The collected upper limit of quantitation for an assay, represented in text format or as a range, such as greater than a specified numeric value. 所收集的定量上限，表示为文本格式或范围，例如大于指定的数值。 | What [is/was] the upper limit of quantitation (for the [measurement/test/examination])? 该[测量/测试/检查]的定量上限是多少？ | Upper Limit of Quantitation 定量上限 | Num 数字 | --ULOQ | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable, --CULOQ maps to the SDTM variable --ULOQ. The units will be those used for --STRESU. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量--CULOQ 映射到 SDTM 变量--ULOQ。单位将是用于--STRESU 的单位。 | N/A | These data may be obtained directly from the lab or the electronic equipment and not collected on the CRF. The units are those used for the SDTM variable --STRESU. This is not the upper limit of normal of the reference range for the test. The SDTM variable --ULOQ must be populated as a numeric. 这些数据可以直接从实验室或电子设备获取，而不是在 CRF 上收集。单位是用于 SDTM 变量--STRESU 的单位。这不是测试参考范围的正常上限。SDTM 变量--ULOQ 必须以数字形式填写。 |
| Findings 发现 | N/A | 44 | --COND | Test Condition Met 测试条件已满足 | An indication whether the testing conditions defined in the protocol were met (e.g. Low fat diet). 指示协议中定义的测试条件是否得到满足（例如，低脂饮食）。 | [Are/Were] the protocol-defined testing conditions met? 协议定义的测试条件是否满足？ | Defined Testing Condition Met 定义的测试条件已满足 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL when SUPP--.QNAM = --COND and SUPP.QLABEL=" Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--.QVAL 的值提交到 SUPP--数据集中，当 SUPP--.QNAM = --COND 且 SUPP.QLABEL="测试条件满足"时。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | (NY) （纽约） | N/A |
| Findings 发现 | N/A | 45 | --CLSIG | Clinical Significance 临床意义 | An indication whether the test results were clinically significant 测试结果是否具有临床意义的指示 | [Is/Was] the ([measurement/test/examination]) result clinically significant? 该（测量/测试/检查）结果在临床上是否具有重要意义？ | ([Measurement/Test/Examination/])/Clinically Significant 临床显著性 | Char 字符 | SUPP--.QVAL | This information could be submitted in a SUPP--dataset as the value of SUPP--.QVAL when SUPP--.QNAM = "CLSIG" and SUPP--.QLABEL = "Clinical Significance". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPP--.QVAL 的值提交到 SUPP--数据集中，当 SUPP--.QNAM = "CLSIG"且 SUPP--.QLABEL = "临床意义"时。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | (NY) （纽约） | N/A |
| Findings 发现 | N/A | 46 | --REPNUM | Repetition Number 重复次数 | The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. 在给定时间范围内对同一测试重复进行的测试实例数量。粒度级别可以有所不同，例如，在某个时间点或在一次访问中。 | What was the repetition number within the time point for this measurement? 这个测量在该时间点的重复次数是多少？ | Repetition Number 重复次数 | Char 字符 | SUPP--.QVAL | This does not map directly to an SDTM variable. This information could be submitted in a SUPP-- dataset as the value of SUPP--.QVAL where SUPP--.QNAM = "--REPNUM" and SUPP--.QLABEL= "Repetition Number within Time Point". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 这并不直接映射到 SDTM 变量。该信息可以作为 SUPP--数据集中的 SUPP--.QVAL 的值提交，其中 SUPP--.QNAM = "--REPNUM"和 SUPP--.QLABEL = "时间点内的重复编号"。请参阅当前的 SDTM 和 SDTMIG 以获取有关在 SDTM 领域中放置非标准变量的说明。 | N/A | The repetition number of the test/measurement within the time point may be pre-printed on the CRF, e.g., multiple measurements of blood pressure or multiple analyses of a sample. 测试/测量在时间点的重复次数可以预先印刷在 CRF 上，例如，血压的多次测量或样本的多次分析。 |
| Findings 发现 | N/A | 47 | --DATFL | Same as Previous Sample Collection date 与之前的样本采集日期相同 | A flag indicating that the date (or start date) is the same as the previous specimen collection date (or start date). 一个标志，表示日期（或开始日期）与之前的样本采集日期（或开始日期）相同。 | [Is/Was] this specimen/sample collected on the same date as the (last/previous specimen/sample) (collected/collection ended)? 该标本/样本是否在与（最后/之前的标本/样本）相同的日期收集（收集结束）？ | Same as (Last/Previous) (Specimen/Sample) (Collection/Collection End) Date 与（上一个/之前的）（标本/样本）（采集/采集结束）日期相同 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | N/A | When a series of specimen are recorded on a single CRF form, this field is tied to the collection date to allow for the flag to be used as a surrogate for the date field. Its selection means that the date of this specimen is the same as the date of the last specimen collected (in the series). Usually a Checkbox, or tick box on the CRF. This would typically be used in the PC domain. 当一系列样本记录在单个 CRF 表单上时，此字段与采集日期相关联，以便将标志用作日期字段的替代。选择此项意味着该样本的日期与最后一个采集的样本（在该系列中）的日期相同。通常是 CRF 上的复选框或勾选框。这通常在 PC 领域使用。 |
| Findings 发现 | N/A | 48 | --ENDATF | Same as Current Sample Collection start date 与当前样本收集开始日期相同 | A flag indicating that the specimen/sample collection ended on the same date as the current/previous specimen collection started. 一个标志，表示样本/标本收集在与当前/之前样本收集开始的同一天结束。 | [Is/Was] this specimen/sample collection ended on the same day as the current specimen's/sample's start date ? 该标本/样本的采集是否在当前标本/样本的开始日期当天结束？ | Same as Current (Specimen's/Sample Collection) start date? 与当前（标本/样本收集）开始日期相同吗？ | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | N/A | When a series of interval sample/specimen collections are recorded on a single CRF form, this field is tied to the start of the current collection to allow for the flag to be used as a surrogate for the date field. Its selection means that the end date of this specimen/sample collection is the same as the start date of the current specimen/sample collected. Usually a Checkbox, or tick box on the CRF. This would typically be used in the PC domain. 当一系列间隔样本/标本收集记录在单个 CRF 表单上时，此字段与当前收集的开始时间相关联，以便将该标志用作日期字段的替代。选择此项意味着该标本/样本收集的结束日期与当前收集的标本/样本的开始日期相同。通常是 CRF 上的复选框或勾选框。这通常在 PC 领域使用。 |
| Findings 发现 | N/A | 49 | COVAL | [domain specific label] [领域特定标签] | A free text comment. 免费文本评论。 | [Protocol-specified Targeted Question]? [协议指定的针对性问题]? | [abbreviated version of the protocol-specified targeted question] [协议规定的目标问题的简化版本] | Char 字符 | CO.COVAL | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable --COVAL maps to the SDTM variable COVAL (COVAL2, COVAL3) in the CO domain. Associate the free text comment in the CO domain with the original record using RDOMAIN, IDVAR, IDVARVAL, COREF. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量--COVAL 映射到 CO 领域中的 SDTM 变量 COVAL（COVAL2，COVAL3）。使用 RDOMAIN、IDVAR、IDVARVAL、COREF 将 CO 领域中的自由文本评论与原始记录关联起来。 | N/A | If an additional free text field is needed to provide a comment about a particular record, use the COVAL(n) field to collect the free text, and associate the free text comment with the original record using SDTM variables RDOMAIN, IDVAR, IDVARVAL, COREF. See the SDTMIG Section 5 for more information. 如果需要额外的自由文本字段来提供关于特定记录的评论，请使用 COVAL(n) 字段收集自由文本，并使用 SDTM 变量 RDOMAIN、IDVAR、IDVARVAL、COREF 将自由文本评论与原始记录关联。有关更多信息，请参见 SDTMIG 第 5 节。 |
| Findings 发现 | N/A | 50 | --MODIFY | Modified Result 修改后的结果 | If the value for --ORRES is modified for coding purposes, then the modified text is placed here. 如果为了编码目的修改了--ORRES 的值，则修改后的文本将放在这里。 | N/A | N/A | Char 字符 | --MODIFY | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process. Rationale for adding coding variables to CDASH is to provide a more complete Data Management package. 这不是将在 CRF 上出现的数据收集字段。赞助商将通过编码过程填充此字段。将编码变量添加到 CDASH 的理由是提供更完整的数据管理包。 |
| Findings 发现 | N/A | 51 | --BODSYS | Body System or Organ Class 身体系统或器官类别 | Body System or Organ Class that is involved for a finding from the standard hierarchy for dictionary-coded results. 涉及标准层级中字典编码结果的发现的身体系统或器官类别。 | What is/was the [body system/ organ system]? 什么是/曾经是[身体系统/器官系统]？ | [Body System/Organ System] [身体系统/器官系统] | Char 字符 | --BODSYS | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | --BODSYS should be assigned using a coding system. If included on the CRF, it is prepopulated and must be paired by the sponsor with specific pre-specified verbatim terms. If not included on the CRF, --BODSYS is assigned through the coding process. --BODSYS 应该使用编码系统进行分配。如果包含在 CRF 中，它会被预填充，并且必须由赞助商与特定的预先指定的逐字术语配对。如果不包含在 CRF 中，--BODSYS 通过编码过程进行分配。 |
2.4 Identifiers 2.4 标识符
Identifiers 标识符
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identifiers 标识符 | N/A | 1 | SPONSOR | Sponsor 赞助商 | An identifier for the entity with the overall regulatory responsibility for the Protocol. 该实体的标识符，负责协议的整体监管。 | What is the sponsor identifier? 赞助商标识符是什么？ | Sponsor 赞助商 | Char 字符 | TSVAL | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". For the SDTM dataset, the value in the CDASH field SPONSOR maps to the SDTM variable TSVAL. The SDTM variable TSPARMCD is populated with "SPONSOR" and the SDTM variable TSPARM is populated with "Clinical Study Sponsor". 直接映射到标题为“SDTM 目标”列中列出的 SDTM 变量。对于 SDTM 数据集，CDASH 字段 SPONSOR 中的值映射到 SDTM 变量 TSVAL。SDTM 变量 TSPARMCD 填充为“SPONSOR”，SDTM 变量 TSPARM 填充为“临床研究赞助商”。 | N/A | In some cases, the combination of Sponsor ID with Study ID and Site ID might be needed by external parties (e.g., CRO or for a multi-sponsor study) to uniquely identify sites belonging to the study for the given sponsor. 在某些情况下，外部方（例如，合同研究组织或多赞助商研究）可能需要将赞助商 ID 与研究 ID 和站点 ID 结合，以唯一识别属于特定赞助商的研究站点。 | ||
| Identifiers 标识符 | N/A | 2 | DOMAIN | Domain Abbreviation 域名缩写 | A two-character abbreviation for the domain most relevant to the observation 与观察最相关的领域的两个字符缩写 | N/A | N/A | Char 字符 | DOMAIN | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (DOMAIN) (域) | This field can be derived into the database or created during SDTM dataset creation before submission. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged. 该字段可以在提交之前导入到数据库中或在 SDTM 数据集创建时创建。领域缩写也用作变量的前缀，以确保在合并数据集时的唯一性。 | ||
| Identifiers 标识符 | N/A | 3 | STUDYID | Study Identifier 研究标识符 | A unique identifier for a study. 研究的唯一标识符。 | What [is/was] the study identifier? 研究标识符是什么？ | [Protocol/Study] [协议/研究] | Char 字符 | STUDYID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | While this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission. 虽然该字段通常不会在 CRF 上捕获，但应在 CRF 和/或 EDC 系统上清晰显示。该字段可以在数据库中包含，或在提交之前在基于 SDTM 的数据集创建过程中填充。 | ||
| Identifiers 标识符 | N/A | 4 | SITEID | Study Site Identifier 研究地点标识符 | A unique identifier for a site within a study. 研究中一个站点的唯一标识符。 | What [is/was] the site identifier? 网站标识符是什么？ | Site Identifier 站点标识符 | Char 字符 | DM.SITEID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Paper: This is typically preprinted in the header of each CRF page for single site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated. 纸张：对于单中心研究，这通常在每个 CRF 页面的页眉中预先打印。对于多中心研究，此字段可以留空，以便由现场记录编号，或者可以为运送到每个现场的 CRF 预先打印。EDC：这应该是预填充的。 | ||
| Identifiers 标识符 | N/A | 5 | INVID | Investigator Identifier 调查员标识符 | An identifier to describe the Investigator for the study. 一个用于描述研究者的标识符。 | What [is/was] the investigator identifier? 调查员标识符是什么？ | Investigator Identifier 调查员标识符 | Char 字符 | DM.INVID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | May be used in addition to the SITEID. Not needed if SITEID is equivalent to INVID. 可以与 SITEID 一起使用。如果 SITEID 等同于 INVID，则不需要。 | ||
| Identifiers 标识符 | N/A | 6 | SUBJID | Subject Identifier for the Study 研究的主题标识符 | A unique subject identifier within a site and a study. 在一个站点和一个研究中的唯一主题标识符。 | What [is/was] the subject identifier? 主题标识符是什么？ | Subject Identifier 主题标识符 | Char 字符 | DM.SUBJID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. The recording of multiple SUBJID for the same subject is a known SDTM issue. If a subject is screened more than once, there may be more than one SUBJID per instance of being screened within the trial. Refer to FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.2. 该 CDASH 变量通常在所有 CDASH 领域中收集。然而，该 CDASH 变量仅在 SDTMIG DM 领域中填充。对于同一受试者记录多个 SUBJID 是一个已知的 SDTM 问题。如果一个受试者被筛选多次，在试验中每次筛选可能会有多个 SUBJID。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.2 节。 | ||
| Identifiers 标识符 | N/A | 8 | FOCID | Focus of Study Specific Interest 研究重点 具体兴趣 | An identifier used for the identification of a focus of study-specific interest on or within a subject or specimen as described in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1", "Biopsy site 1", "Treated site 1", or a more specific focus, e.g., "OD" (right eye) or "Upper left quadrant of the back". The value in this variable should have inherent semantic meaning. 用于识别在协议中描述的主题或标本上或内部特定研究兴趣焦点的标识符，进行测量、测试或检查，例如药物应用部位，例如“注射部位 1”、“活检部位 1”、“处理部位 1”，或更具体的焦点，例如“OD”（右眼）或“背部左上象限”。该变量中的值应具有固有的语义意义。 | [Protocol specific question]? [协议特定问题]? | [Protocol Specific Prompt] [协议特定提示] | Char 字符 | FOCID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This SDTM variable has been defined in SDTM 1.5, but was not included in SDTMIG 3.2. Sponsors should consider the SDTM version being used when the submission datasets are created. In pre SDTM 1.5, the CDASH to SDTM mapping may need to be defined by the sponsor because FOCID is not a valid SDTM variable in these versions. 该 SDTM 变量在 SDTM 1.5 中已定义，但未包含在 SDTMIG 3.2 中。赞助商在创建提交数据集时应考虑所使用的 SDTM 版本。在 SDTM 1.5 之前，CDASH 到 SDTM 的映射可能需要由赞助商定义，因为 FOCID 在这些版本中不是有效的 SDTM 变量。 | ||
| Identifiers 标识符 | N/A | 9 | --SPID | Sponsor-Defined Identifier 赞助商定义的标识符 | A sponsor-defined identifier which can be used for pre-printed or auto-generated numbers on the CRF. 一个由赞助商定义的标识符，可用于 CRF 上的预印刷或自动生成的号码。 | What [is/was] the [test/procedure/observation] identifier? 测试标识符是什么？ | [Line Number/-- Number] [行号/-- 数字] | Char 字符 | --SPID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". May be used to create RELREC to link this record with a record in another domain. 直接映射到“SDTM 目标”列中列出的 SDTM 变量。可用于创建 RELREC，以将此记录与另一个领域中的记录链接。 | N/A | Since SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system. 由于 SPID 是由赞助商定义的标识符，因此不适用于问题文本或项目提示的符合性。通常用作数据查询中的标识符，以清晰地向现场传达特定记录或对数据进行核对。可用于在 CRF 上记录预印刷的号码（例如，行号、记录号）。该字段可能由赞助商的数据收集系统填充。 | ||
| Identifiers 标识符 | N/A | 10 | --GRPID | Group ID 组 ID | A group identifier used to link together a block of related records within a subject in a domain. 用于将域中主题内一组相关记录链接在一起的组标识符。 | What [is/was] the [test/procedure/observation] group identifier? 测试组标识符是什么？ | [Test/Procedure/Observation] Group Identifier [测试/程序/观察] 组标识符 | Char 字符 | --GRPID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Used to link together a block of related records in a single domain for a subject. This group identifier may be used to tie together all the tests collected in a Findings domain using a de-normalized approach (See CDASHIG Section 8.3 -General CDASH Assumptions for Findings Domains). This field may be populated by the sponsor's data management system. 用于将一个主题的相关记录块链接在单一领域中。该组标识符可用于通过去规范化方法将所有在发现领域中收集的测试联系在一起（参见 CDASHIG 第 8.3 节 - 发现领域的一般 CDASH 假设）。该字段可能由赞助商的数据管理系统填充。 | ||
| Identifiers 标识符 | N/A | 11 | --LNKID | Link ID 链接 ID | An identifier used to link related records across domains. 用于跨域链接相关记录的标识符。 | What [is/was] the [test/procedure/observation] identifier? 测试标识符是什么？ | [Domain/Observation] Link Identifier [域/观察] 链接标识符 | Char 字符 | --LNKID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This may be a one-to- one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit. 这可能是一对一或一对多的关系。例如：一个肿瘤在每次研究访问中可能会进行多次测量/评估。 | ||
| Identifiers 标识符 | N/A | 12 | --LNKGRP | Link Group ID 链接组 ID | An identifier used to link related records across domains. 用于跨域链接相关记录的标识符。 | What [is/was] the [domain/observation] link group ID? 该[域/观察]链接组 ID 是什么？ | [Domain/Observation] Link Group Identifier [域/观察] 链接组标识符 | Char 字符 | --LNKGRP | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record. 这通常是多对一的关系。例如：多个肿瘤测量/评估将有助于单一的治疗反应确定记录。 | ||
| Identifiers 标识符 | N/A | 13 | --AENO | Related Adverse Event ID 相关不良事件 ID | A numerical identifier for the adverse event that is associated with/related to this intervention/finding/event. 与此干预/发现/事件相关的不良事件的数字标识符。 | What [is/was] the identifier for the adverse event(s) [associated with/related to this intervention/finding/event]? 与该干预/发现/事件相关的不良事件的标识符是什么？ | Adverse Event Identifier 不良事件标识符 | Char 字符 | N/A | This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Adverse Experience domain. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，可以用来创建 RELREC，以将此记录与相关不良事件领域中的记录链接。 | N/A | Name of the identifying variable is stored in the SDTM variable IDVAR (e.g., --AENO) and the value of the SDTM variable IDVAR is stored in SDTM variable IDVARVAL. Example question text: What was the identifier for the adverse event associated with this concomitant medication? 识别变量的名称存储在 SDTM 变量 IDVAR 中（例如，--AENO），SDTM 变量 IDVAR 的值存储在 SDTM 变量 IDVARVAL 中。示例问题文本：与此伴随用药相关的不良事件的标识符是什么？ | ||
| Identifiers 标识符 | N/A | 13 | --REFID | Reference ID 参考 ID | An internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image. 内部或外部标识符，例如实验室样本 ID，或用于 ECG 波形或医学图像的 UUID。 | What [is/was] the [test/procedure/domain/observation/specimen/sample] [reference identifier/accession number/identifier]? 该[测试/程序/领域/观察/标本/样本]的[参考标识符/接收编号/标识符]是什么？ | [Test/Procedure/Domain/Observation/Specimen/Sample] [Reference/Accession Number/Identifier] [测试/程序/领域/观察/标本/样本] [参考/接收编号/标识符] | Char 字符 | --REFID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | N/A | ||
| Identifiers 标识符 | N/A | 14 | --MHNO | Related Medical History Event ID 相关医疗历史事件 ID | A numerical identifier for the medical history event that is associated with/related to this intervention/finding/event. 与此干预/发现/事件相关的医疗历史事件的数字标识符。 | What [is/was] the identifier for the medical history event(s) [associated with/related to this intervention/finding/event]? 与此干预/发现/事件相关的医疗历史事件的标识符是什么？ | Medical History Event Identifier 医疗历史事件标识符 | Char 字符 | N/A | This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Medical History domain. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，可以用于创建 RELREC，以将此记录与相关医学历史领域中的记录链接。 | N/A | Name of the identifying variable is stored as a value in the SDTM variable IDVAR (e.g., "--MHNO") and the value of the IDVAR is stored in the STDM variable IDVARVAL. Example question text prompt: What was the identifier for the medical history event associated with this concomitant medication? 识别变量的名称作为值存储在 SDTM 变量 IDVAR 中（例如，“--MHNO”），IDVAR 的值存储在 STDM 变量 IDVARVAL 中。示例问题文本提示：与此伴随用药相关的医疗历史事件的标识符是什么？ | ||
| Identifiers 标识符 | N/A | 15 | --PRNO | Related Procedure ID 相关程序 ID | A numerical identifier for the procedure that is associated with/related to this intervention/finding/event. 与此干预/发现/事件相关的程序的数字标识符。 | What [is/was] the identifier for the procedure(s) [associated with/related to this intervention/finding/event]? 该程序（与此干预/发现/事件相关）的标识符是什么？ | Procedure Identifier 程序标识符 | Char 字符 | N/A | This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Procedures domain. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，可以用于创建 RELREC，以将此记录与相关程序域中的记录链接。 | N/A | Name of the identifying variable is stored as a value in the SDTM variable IDVAR (e.g., "--PRNO") and the value of the IDVAR is stored in the SDTM variable IDVARVAL. Example question text for an Adverse Event CRF: What was the identifier for the procedure associated with this adverse event? 识别变量的名称作为值存储在 SDTM 变量 IDVAR 中（例如，“--PRNO”），IDVAR 的值存储在 SDTM 变量 IDVARVAL 中。关于不良事件 CRF 的示例问题文本：与此不良事件相关的程序标识符是什么？ | ||
| Identifiers 标识符 | N/A | 16 | --CENO | Related Clinical Event ID 相关临床事件 ID | A numerical identifier for the clinical event that is associated with/related to this intervention/finding/event. 与此干预/发现/事件相关的临床事件的数字标识符。 | What [is/was] the identifier for the clinical event(s) [associated with/related to this intervention/finding/event]? 与该干预/发现/事件相关的临床事件的标识符是什么？ | Clinical Event Identifier 临床事件标识符 | Char 字符 | N/A | This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Clinical Events domain. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，可以用于创建 RELREC，以将此记录与相关临床事件领域中的记录链接。 | N/A | Name of the identifying variable is stored as a value in the SDTM variable IDVAR ("--CENO") and the value of the IDVAR is stored in the SDTM variable IDVARVAL Example question text: What was the identifier for the clinical event associated with this procedure? 识别变量的名称作为值存储在 SDTM 变量 IDVAR（“--CENO”）中，IDVAR 的值存储在 SDTM 变量 IDVARVAL 中。示例问题文本：与此程序相关的临床事件的标识符是什么？ | ||
| Identifiers 标识符 | N/A | 17 | SPDEVID | Sponsor Device Identifier 赞助设备标识符 | A sponsor-defined identifier for a device 设备的赞助商定义标识符 | What [is/was] the sponsor identifier for the device? 该设备的赞助商标识符是什么？ | Sponsor Device Identifier 赞助设备标识符 | Char 字符 | SPDEVID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | SPDEVID is a constructed variable consisting of elements that may not be available at the time of data capture, such as device type, manufacturer, and other elements. Other device identifiers, such as serial number, may instead be used on the CRF. If this is the case, sponsors should use the controlled terminology for the SPDEVID elements as variable names where possible. Sponsors should also ensure that, when necessary, those elements required for deriving SPDEVID are captured. SPDEVID 是一个构造变量，由在数据捕获时可能不可用的元素组成，例如设备类型、制造商和其他元素。其他设备标识符，例如序列号，可能会在 CRF 上使用。如果是这种情况，赞助商应尽可能使用 SPDEVID 元素的受控术语作为变量名称。赞助商还应确保在必要时捕获用于推导 SPDEVID 的那些元素。 | ||
2.5 Timing 2.5 时间安排
Timing 时机
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Timing 时机 | N/A | 1 | VISITNUM | Visit Number 访问次数 | Clinical encounter number. Numeric version of VISIT can be used for sorting. 临床接触编号。可以使用 VISIT 的数字版本进行排序。 | What is the visit number? 访问次数是多少？ | Visit Number 访问次数 | Num 数字 | VISITNUM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | This is not a data collection field that will appear on the CRF itself. This field may be populated by the sponsor's data collection system or derived from the variable VISIT. Note: Sponsors may have CDASH visit numbering or visit naming conventions to handle special circumstances (e.g., unscheduled visits). In these cases, the appropriate visit numbers and visit names, may need to be populated when the SDTM submission datasets are created. 这不是将在 CRF 上出现的数据收集字段。该字段可能由赞助商的数据收集系统填充或从变量 VISIT 派生。注意：赞助商可能有 CDASH 访问编号或访问命名约定来处理特殊情况（例如，非计划访问）。在这些情况下，创建 SDTM 提交数据集时，可能需要填充适当的访问编号和访问名称。 |
| Timing 时机 | N/A | 2 | VISIT | Visit Name 访问名称 | Protocol-defined description of the clinical encounter. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter. 协议定义的临床接触描述。可作为临床接触的文本描述，附加于 VISITNUM 和/或 VISITDY。 | What [is/was] the visit name? 访问名称是什么？ | [Visit] [访问] | Char 字符 | VISIT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | The name of the visit is typically pre-printed on the CRF, and should match the name of the visit in the protocol. May be used to derive the SDTM variable VISITNUM. Note: Sponsors may have CDASH visit numbering or visit naming conventions to handle special circumstances (e.g., unscheduled visits). In these cases, the appropriate visit numbers and visit names, may need to be populated when the SDTM submission datasets are created. 访问名称通常会预先印刷在 CRF 上，并应与方案中的访问名称匹配。可用于推导 SDTM 变量 VISITNUM。注意：赞助商可能有 CDASH 访问编号或访问命名约定来处理特殊情况（例如，非计划访问）。在这些情况下，创建 SDTM 提交数据集时，可能需要填充适当的访问编号和访问名称。 |
| Timing 时机 | N/A | 3 | VISDAT | Visit Date 访问日期 | Date the clinical encounter occurred (or started). 临床接触发生（或开始）的日期。 | What [is/was] the date of the visit? 访问的日期是什么？ | Visit Date 访问日期 | Char 字符 | N/A | This field does not map directly to an SDTM variable. For the SDTMIG SV dataset, the SDTMIG variable SVSTDTC may be derived by concatenating all collected CDASH VISDAT and VISTIM components and populating the SDTM variable SVSTDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTMIG SV 数据集，SDTMIG 变量 SVSTDTC 可以通过连接所有收集的 CDASH VISDAT 和 VISTIM 组件来派生，并以 ISO 8601 格式填充 SDTM 变量 SVSTDTC。 | N/A | This may be recorded in either the header of the CRF or in the body of the CRF. A date/time can be collected once for the whole visit using the Visit Date/Time field and applying that date/time to all of the observations at that visit. The date (--DTC) of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components, and populating the STDMIG variable --DTC in ISO 8601 format. 这可以记录在 CRF 的标题或 CRF 的主体中。可以使用访问日期/时间字段收集一次整个访问的日期/时间，并将该日期/时间应用于该访问的所有观察。测量、测试、观察的日期（--DTC）可以从访问的日期/时间（VISDAT/VISTIM）中确定，然后连接 CDASH VISDAT/VISTIM 组件，并以 ISO 8601 格式填充 STDMIG 变量--DTC。 |
| Timing 时机 | N/A | 4 | VISTIM | Visit Time 访问时间 | Time the clinical encounter took place (or started). 临床接触发生（或开始）的时间。 | What [is/was] the (start) time of the visit? 访问的开始时间是什么？ | Visit Time 访问时间 | Char 字符 | N/A | This field does not map directly to an SDTM variable. For the SDTMIG SV dataset, the SDTMIG variable SVSTDTC may be derived by concatenating all collected CDASH VISDAT and VISTIM components and populating the SDTM variable SVSTDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTMIG SV 数据集，SDTMIG 变量 SVSTDTC 可以通过连接所有收集的 CDASH VISDAT 和 VISTIM 组件来派生，并以 ISO 8601 格式填充 SDTM 变量 SVSTDTC。 | N/A | This may be recorded in either the header of the CRF or in the body of the CRF. A date/time can be collected once for the whole visit using the Visit Date/Time field and applying that date/time to all of the observations at that visit. The date (--DTC) of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM). For the SDTM submission datasets, concatenate CDASH VISDAT/VISTIM components, and populate the STDMIG variable --DTC in ISO 8601 format. May be used to populate SVSTDTC, and SVENDTC in the SDTMIG SV domain. 这可以记录在 CRF 的标题或 CRF 的主体中。可以使用访问日期/时间字段收集一次整个访问的日期/时间，并将该日期/时间应用于该访问的所有观察。测量、测试、观察的日期（--DTC）可以从访问的日期/时间（VISDAT/VISTIM）确定。对于 SDTM 提交数据集，连接 CDASH VISDAT/VISTIM 组件，并以 ISO 8601 格式填充 STDMIG 变量--DTC。可以用于填充 SDTMIG SV 域中的 SVSTDTC 和 SVENDTC。 |
| Timing 时机 | N/A | 5 | VISENDAT | Visit End Date 访问结束日期 | Date the clinical encounter ended. 临床接触结束的日期。 | What [is/was] the end date of the visit? 访问的结束日期是什么？ | Visit End Date 访问结束日期 | Char 字符 | N/A | This field does not map directly to an SDTM variable. For the SDTM SV dataset, the SDTMIG variable SVENDTC may be derived by concatenating all collected CDASH VISENDAT and VISENTIM components and populating the SDTM variable SVENDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM SV 数据集，SDTMIG 变量 SVENDTC 可以通过连接所有收集的 CDASH VISENDAT 和 VISENTIM 组件来派生，并以 ISO 8601 格式填充 SDTM 变量 SVENDTC。 | N/A | This may be recorded in either the header of the CRF or in the body of the CRF. This is the end date of the visit. This may be useful when a study extends over 2 or more days. 这可以记录在 CRF 的标题或 CRF 的主体中。这是访问的结束日期。当研究持续超过两天时，这可能会很有用。 |
| Timing 时机 | N/A | 6 | VISENTIM | Visit End Time 访问结束时间 | Time the clinical encounter ended. 临床接触结束的时间。 | What [is/was] the end time of the visit? 访问的结束时间是什么？ | Visit End Time 访问结束时间 | Char 字符 | N/A | This field does not map directly to an SDTM variable. For the SDTM SV dataset, the SDTMIG variable SVENDTC may be derived by concatenating all collected CDASH VISENDAT and VISENTIM components and populating the SDTM variable SVENDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM SV 数据集，SDTMIG 变量 SVENDTC 可以通过连接所有收集的 CDASH VISENDAT 和 VISENTIM 组件来派生，并以 ISO 8601 格式填充 SDTM 变量 SVENDTC。 | N/A | This may be recorded in either the header of the CRF or in the body of the CRF. This is the end time of the visit. This may be useful when a study extends over 2 or more days. 这可以记录在 CRF 的标题或 CRF 的正文中。这是访问的结束时间。当研究持续超过两天时，这可能会很有用。 |
| Timing 时机 | N/A | 7 | EPOCH | Epoch 纪元 | Name of the Trial Epoch with which this Element of the Arm is associated. 与该臂部件相关的试验时代名称。 | What [is/was] the trial [period/phase/sponsor-defined phrase] (for this [event/intervention/finding])? 该[事件/干预/发现]的试用[期/阶段/赞助商定义的短语]是什么？ | Trial Period 试用期 | Char 字符 | EPOCH | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (EPOCH) （时代） | If the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page. See SDTMIG for further information regarding EPOCH. 如果在研究的不同时间段/部分中收集相同的信息超过一次（例如，处置），可能需要使用 EPOCH 来区分它们。通常，试验时期将在 CRF 上预先打印为页面标题。有关 EPOCH 的更多信息，请参见 SDTMIG。 |
| Timing 时机 | N/A | 8 | --DAT | Date of Collection 采集日期 | Collection date of an observation. 观察的采集日期。 | What [is/ was] the date the [event or intervention] [is/was] collected?; What [is/ was] the (start) date (of the [Finding])? 事件或干预的收集日期是什么？; [发现]的（开始）日期是什么？ | [Event/Intervention] Collection Date; [Finding] (Start) Date [事件/干预] 收集日期; [发现] (开始) 日期 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.4.1 节，其中指出当日期作为时间变量时，应将匹配的研究天数变量（--DY、--STDY 或--ENDY）包含在 SDTM 数据集中。 | N/A | This is a generic DATE field that can be implemented in a system that will store partial dates. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) . Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) are included in the SDTM 这是一个通用的日期字段，可以在存储部分日期的系统中实现。可用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期） 5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期）。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）将包含在 SDTM 中。 |
| Timing 时机 | N/A | 9 | --DATDD | Day of Collection 收集日 | Collection day of an observation. 观察的收集日。 | What [is/was] the day the [event or intervention] [is/was] collected?; What [is/was] was the (start) day (of the [Finding])? 收集[事件或干预]的日期是什么？; [发现]的（开始）日期是什么？ | [Event/Intervention] Collection Day; [Finding] (Start) Day [事件/干预] 收集日; [发现]（开始）日 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.4.1 节，其中指出当日期作为时间变量时，应将匹配的研究天数变量（--DY、--STDY 或--ENDY）包含在 SDTM 数据集中。 | N/A | This is a generic DAY (DD) field that can be implemented in a system that will not store partial dates. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的日期（DD）字段，可以在不存储部分日期的系统中实现。可用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 10 | --DATMO | Month of Collection 收集月份 | Collection month of an observation. 观察的采集月份。 | What [is/was] the month the [event or Intervention] [is/was] collected?; What [is/was] the (start) month (of the [Finding])? 事件或干预的收集月份是什么？; [发现]的开始月份是什么？ | [Event/Intervention] Collection Month; [Finding] (Start) Month [事件/干预] 收集月份; [发现]（开始）月份 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic MONTH (MO) field that can be implemented in a system that will not store partial dates. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的月份（MO）字段，可以在不存储部分日期的系统中实现。可用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 11 | --DATYY | Year of Collection 收集年份 | Collection year of an observation. 观察的收集年份。 | What [is/was] the year the [event or intervention] [is/was] collected?; What [is/ was] the (start) year (of the [Finding])? 事件或干预的收集年份是什么？; [发现]的起始年份是什么？ | [Event/Intervention] Collection Month; [Finding] (Start) Month [事件/干预] 收集月份; [发现]（开始）月份 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic YEAR (YY) field that can be implemented in a system that will not store partial dates. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的年份（YY）字段，可以在不存储部分日期的系统中实现。可用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 12 | --TIM | Time of Collection 采集时间 | Collection time of an observation. 观察的采集时间。 | What [is/was] the time the [event or intervention] [is/was] collected?; What [is/was] the (start) time (of the [Finding])? 事件或干预的收集时间是什么？; [发现]的开始时间是什么？ | [Event/Intervention] Collection Time; [Finding] (Start) Time [事件/干预] 收集时间; [发现] (开始) 时间 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic TIME (TIM) field that can be implemented in a system that will store partial times. Use this for: 1. Date of data collection 2.. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的时间（TIM）字段，可以在存储部分时间的系统中实现。用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 13 | --TIMHR | Hour of Collection 收集时间 | Collection hour of an observation. 观察的采集时间。 | What [is/was] the hour the [event or intervention] [is/was] collected?; What [is/was ] the (start) hour (of the [Finding])? 事件或干预的收集时间是什么？; [发现]的开始时间是什么？ | [Event/Intervention] Collection Hour; [Finding] (Start) Hour [事件/干预] 收集时间; [发现] (开始) 时间 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic HOUR (HR) field that can be implemented in a system that will not store partial times. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的小时（HR）字段，可以在不存储部分时间的系统中实现。用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 14 | --TIMMI | Minute of Collection 收集分钟 | Collection minute of an observation. 观察的收集分钟。 | What [is/was] the minute the [event or intervention] [is/was] collected?; What [is/ was] the (start) minute (of the [Finding])? 事件或干预被收集的那一分钟是什么？; [发现]的开始分钟是什么？ | [Event/Intervention] Collection Minute; [Finding] (Start) Minute [事件/干预] 收集分钟; [发现] (开始) 分钟 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic MINUTE (MI) field that can be implemented in a system that will not store partial times. Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的分钟（MI）字段，可以在不存储部分时间的系统中实现。用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 15 | --TIMSS | Second of Collection 第二次收藏 | Collection second of an observation. 观察的第二次收集。 | What [is/was] the second the [event or intervention] [is/was] collected?; Or What [is/was] the (start) second (of the [Finding])? 第二个[事件或干预]是在什么时候收集的？或者[发现]的（开始）第二秒是什么时候？ | [Event/Intervention] Collection Second; [Finding] (Start) Second [事件/干预] 收集第二；[发现]（开始）第二 | Char 字符 | --DTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --DTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--DTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic SECONDS (SS) field that can be implemented in a system that will not store partial times Use this for: 1. Date of data collection 2. Visit date 3. Visit start date 4. Point in time collection (e.g., vital signs measurements, lab sample collection date) 5. Start date for interval collection of measurements or tests (e.g., start date of a 24-hour urine collection) 这是一个通用的秒（SS）字段，可以在不存储部分时间的系统中实现。可用于：1. 数据收集日期 2. 访问日期 3. 访问开始日期 4. 时间点收集（例如，生命体征测量、实验室样本收集日期）5. 测量或测试的间隔收集开始日期（例如，24 小时尿液收集的开始日期） |
| Timing 时机 | N/A | 16 | --STDAT | Start Date of Observation 观察开始日期 | Start date of an observation. 观察开始日期。 | What [is/was] the (intended/actual) [event/intervention] (start/admission) date ((of the observation) ? [观察]的（预定/实际）[事件/干预]（开始/入院）日期是什么？ | [Intended/Actual] [Start/Admission] Date [预定/实际] [开始/入学] 日期 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START DATE field that can be implemented in a system that will store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始日期字段，可以在存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 17 | --STDD | Start Day of Observation 观察开始日 | Start day of an observation. 观察开始日期。 | What [is/ was] the [intended/actual] [event/intervention] [start/admission] day? 什么是[计划的/实际的][事件/干预][开始/入院]日期？ | [Intended/Actual] [Start/Admission] Day [预定/实际] [开始/入学] 日 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable--STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY，--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START DAY (STDD) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始日期（STDD）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 18 | --STMO | Start Month of Observation 观察开始月份 | Start month of an observation. 观察的开始月份。 | What [is/was] the intended/actual] [event/Intervention] start month? 预定/实际的事件/干预开始月份是什么？ | [Intended/Actual] [Start/Admission] Month [计划/实际] [开始/入学] 月份 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START MONTH (STMO) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始月份（STMO）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 19 | --STYY | Start Year of Observation 观察开始年份 | Start year of an observation. 观察的开始年份。 | What [is/was] the [intended/actual] [event/intervention] [start/admission] year? 该事件/干预的计划/实际开始/入院年份是什么？ | [Intended/Actual] [Start/Admission] Year [计划/实际] [开始/入学] 年份 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START YEAR (STYY) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始年份（STYY）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 20 | --STTIM | Start Time of Observation 观察开始时间 | Start time of an observation. 观察开始时间。 | What [is/was] the [intended/actual] [event/intervention] [start/admission] time? 预定的事件开始时间是什么？ | [Intended/Actual] [Start/Admission] Time [预定/实际] [开始/入学] 时间 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START TIME field that can be implemented in a system that will store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2.Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始时间字段，可以在存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 21 | --STHR | Start Hour of Observation 观察开始时间 | Start hour of an observation. 观察开始时间。 | What [is/was] the [intended/actual] [event/intervention] [start/admission] hour? 预定的事件开始时间是什么？ | [Intended/Actual] [Start/Admission] Hour [计划/实际] [开始/入学] 时间 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START HOUR (STHR) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始时间（STHR）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 22 | --STMI | Start Minute of Observation 观察开始分钟 | Start minute of an observation. 观察的开始分钟。 | What [is/was] the [intended/actual] [event/intervention] [start/admission] minute? 什么是[预定/实际]的[事件/干预]的[开始/入院]分钟？ | [Intended/Actual] [Start/Admission] Minute [计划/实际] [开始/入学] 分钟 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START MINUTE (STMI) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4.Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始分钟（STMI）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 23 | --STSS | Start Second of Observation 开始第二次观察 | Start second of an observation. 开始第二次观察。 | What [is/was] the [intended/actual] [event/intervention] [start/admission] second? 什么是[预定的/实际的][事件/干预][开始/入院]秒？ | [Intended/Actual] [Start/Admission] Second [意向/实际] [开始/入学] 第二 | Char 字符 | --STDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTM variable --STDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 开始日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--STDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic START SECOND (STSS) field that can be implemented in a system that will not store partial dates. Use this for: 1. Start date of events or interventions (e.g., AE start date, Substance Use start date) 2. Start date of interval dosing (e.g., date/time of infusion start) 3. Date of Protocol Milestones (e.g., informed consent date) 4. Date of Disposition events (e.g., date of study completion, date of discontinuation) 这是一个通用的开始第二（STSS）字段，可以在不存储部分日期的系统中实现。用于：1. 事件或干预的开始日期（例如，AE 开始日期，物质使用开始日期）2. 间隔给药的开始日期（例如，输注开始的日期/时间）3. 方案里程碑的日期（例如，知情同意日期）4. 处置事件的日期（例如，研究完成日期，停用日期） |
| Timing 时机 | N/A | 24 | --ENDAT | End Date of Observation 观察结束日期 | End date of an observation. 观察结束日期。 | What [is/was] the (intended/actual) [event/intervention] [end/discharge] date (of the observation) ? 观察的（预定/实际）[事件/干预] [结束/出院]日期是什么？ | [Intended/Actual] [End/Discharge] Date [预定/实际] [结束/放电] 日期 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END DATE field that can be implemented in a system that will store partial dates. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束日期字段，可以在存储部分日期的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输注结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 25 | --ENDD | End Day of Observation 观察结束日 | End day of an observation. 观察结束日。 | What [is/was] the [intended/actual] [event/intervention/Finding] [end/discharge] day? 预定的出院日期是什么？ | [Intended/Actual] [End/Discharge] Day [预定/实际] [结束/出院] 日 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END DAY (ENDD) field that can be implemented in a system that will not store partial dates. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束日期（ENDD）字段，可以在不存储部分日期的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输注结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 26 | --ENMO | End Month of Observation 观察结束月份 | End month of an observation. 观察的月底。 | What [is/was] the [intended/actual] [event/intervention/finding] [end/discharge] month? 您所指的[预定/实际] [事件/干预/发现] [结束/出院]月份是什么？ | [Intended/Actual] [End/Discharge] Month [预期/实际] [结束/出院] 月份 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END MONTH (ENMO) field that can be implemented in a system that will not store partial dates. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束月份（ENMO）字段，可以在不存储部分日期的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输注结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 27 | --ENYY | End Year of Observation 观察结束年份 | End year of an observation. 观察的结束年份。 | What [is/was] the [intended/actual] [event/intervention/finding] [end/discharge] year? 您所指的[预期/实际] [事件/干预/发现] [结束/出院]年份是什么？ | [Intended/Actual] [End/Discharge] Year [计划/实际] [结束/排放] 年 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END YEAR (ENYY) field that can be implemented in a system that will not store partial dates. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的年末（ENYY）字段，可以在不存储部分日期的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输注结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 28 | --ENTIM | End Time of Observation 观察结束时间 | End time of an observation. 观察结束时间。 | What [is/was] the [intended/actual] [event/intervention/finding][end/discharge]time? 预定的事件结束时间是什么？ | [Intended/Actual] [End/Discharge] Time [预定/实际] [结束/放电] 时间 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END TIME (ENTIM) field that can be implemented in a system that will store partial times. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束时间（ENTIM）字段，可以在存储部分时间的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输液结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 29 | --ENHR | End Hour of Observation 观察结束时间 | End hour of an observation. 观察结束时间。 | What [is/was] the [intended/actual] [event/intervention/finding] end hour? 预定的事件结束时间是什么？ | [Intended/Actual] [End/Discharge] Hour [计划/实际] [结束/放电] 小时 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END HOUR (ENHR) field that can be implemented in a system that will not store partial times. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束时间（ENHR）字段，可以在不存储部分时间的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输液结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 30 | --ENMI | End Minute of Observation 观察结束时刻 | End minute of an observation. 观察的结束时刻。 | What [is/was] the [intended/actual] [event/intervention/finding] [end/discharge] minute? 什么是[预定的/实际的][事件/干预/发现][结束/出院]分钟？ | [Intended/Actual] End/Discharge] Minute [预期/实际] 结束/排放] 分钟 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END MINUTE (ENMI) field that can be implemented in a system that will not store partial times. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束分钟（ENMI）字段，可以在不存储部分时间的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输液结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 31 | --ENSS | End Second of Observation 结束观察的第二秒 | End second of an observation. 观察的结束秒。 | What [is/was] the [Intended/actual] [event/intervention/finding] [end/discharge] second? 第二次[意图/实际]的[事件/干预/发现][结束/出院]是什么？ | [Intended/Actual] [End/Discharge] Second [意图/实际] [结束/放电] 第二 | Char 字符 | --ENDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH End DATE and TIME components and populate the SDTM variable --ENDTC in ISO 8601 format. Refer to the FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015): Section 4.1.4.1 which indicates that when dates have the role of a timing variable, the matching Study Day variables (--DY, --STDY, or --ENDY, respectively) should be included in the SDTM dataset. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 结束日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量--ENDTC。请参阅 FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）：第 4.1.4.1 节，其中指出当日期作为时间变量时，匹配的研究天数变量（--DY、--STDY 或--ENDY）应包含在 SDTM 数据集中。 | N/A | This is a generic END SECOND (ENSS) field that can be implemented in a system that will not store partial dates. Use this for: 1. End date of events (e.g., AE end date) or Interventions (e.g., CM end date) 2. End date of interval dosing (e.g., date of infusion end) 3. End visit date 4. End date for interval collection of measurements or tests (e.g., end date of 24-hour urine collection) 这是一个通用的结束第二（ENSS）字段，可以在不存储部分日期的系统中实现。用于：1. 事件的结束日期（例如，AE 结束日期）或干预（例如，CM 结束日期） 2. 间隔给药的结束日期（例如，输液结束日期） 3. 结束访视日期 4. 测量或测试的间隔收集结束日期（例如，24 小时尿液收集的结束日期） |
| Timing 时机 | N/A | 32 | --CDUR | Collected Duration 收集时长 | Collected duration of an event, intervention, or finding. Used only if collected on the CRF and not derived. 事件、干预或发现的收集持续时间。仅在 CRF 上收集时使用，而不是推导得出。 | What [is/was] the duration of the [event/intervention]? 该[事件/干预]的持续时间是多长？ | Duration 持续时间 | Char 字符 | --DUR | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate the collected CDASH duration and the CDASH duration unit components and populate the SDTM variable --DUR in ISO 8601 Period format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将收集的 CDASH 持续时间和 CDASH 持续时间单位组件连接起来，并以 ISO 8601 期间格式填充 SDTM 变量--DUR。 | N/A | Used only if collected on the CRF and not derived. 仅在 CRF 上收集且未派生时使用。 |
| Timing 时机 | N/A | 33 | --CDURU | Collected Duration Unit 收集的持续时间单位 | The unit of time associated with the collected duration of an event, intervention, or finding. 与事件、干预或发现的收集持续时间相关的时间单位。 | What [is/was] the duration unit of the [event/intervention]? 事件/干预的持续时间单位是什么？ | [Duration Unit] [持续时间单位] | Char 字符 | --DUR | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate the collected CDASH duration and the CDASH duration unit components and populate the SDTM variable --DUR in ISO 8601 Period format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将收集的 CDASH 持续时间和 CDASH 持续时间单位组件连接起来，并以 ISO 8601 期间格式填充 SDTM 变量--DUR。 | UNIT | Used only if collected on the CRF and not derived. 仅在 CRF 上收集且未派生时使用。 |
| Timing 时机 | N/A | 34 | --TPT | Planned Time Point Name 计划时间点名称 | Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See --TPTNUM and --TPTREF. 测量或观察应在协议中定义的时间的文本描述。这可以表示为相对于固定参考点（例如最后一次给药时间）的经过时间。参见 --TPTNUM 和 --TPTREF。 | What [is/was] the planned time point [of the/for the] [measurement/observation/collection]? 计划的测量/观察/收集时间点是什么？ | [Planned Time Point Name] [计划时间点名称] | Char 字符 | --TPT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". See SDTMIG for additional information on representing time points. SDTM Time point anchors --TPTREF (text description) and --RFTDTC (date/time) may be needed, as well as SDTM variables --TPTNUM, --ELTM. 直接映射到“SDTM 目标”列中列出的 SDTM 变量。有关表示时间点的更多信息，请参见 SDTMIG。可能需要 SDTM 时间点锚点--TPTREF（文本描述）和--RFTDTC（日期/时间），以及 SDTM 变量--TPTNUM，--ELTM。 | N/A | Planned time point names are needed to differentiate multiple sequential assessments. It is recommended that time point names be pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Planned Time Point can be included as the column header. In the SDTM submission dataset, time points can be represented using the time point variables --TPT, --TPTNUM,-- ELTM. See SDTMIG Section 4.1.4.10. 需要计划时间点名称以区分多个连续评估。建议在 CRF 上预先打印时间点名称，而不是在需要现场输入文本的字段中收集。如果表格布局为网格，则可以将“计划时间点”等词作为列标题包含在内。在 SDTM 提交数据集中，时间点可以使用时间点变量--TPT、--TPTNUM、--ELTM 表示。请参见 SDTMIG 第 4.1.4.10 节。 |
| Timing 时机 | N/A | 35 | --TPTNUM | Planned Time Point Number 计划时间点编号 | Numeric version of planned time point used in sorting. 用于排序的计划时间点的数字版本。 | What [is/was] the planned time point number [of the/for the] [measurement/observation/collection]? 计划的时间点编号是多少？ | [Planned Time Point Number] [计划时间点编号] | Num 数字 | --TPTNUM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". See SDTMIG for additional information on representing time points. SDTM Time point anchors --TPTREF (text description) and --RFTDTC (date/time) may be needed, as well as SDTM variables --TPTNUM, --ELTM. 直接映射到“SDTM 目标”列中列出的 SDTM 变量。有关表示时间点的更多信息，请参见 SDTMIG。可能需要 SDTM 时间点锚点--TPTREF（文本描述）和--RFTDTC（日期/时间），以及 SDTM 变量--TPTNUM，--ELTM。 | N/A | Planned time point numbers may be needed to differentiate multiple sequential assessments. If collected, it is recommended that time point numbers pre-printed on the CRF. In the SDTM submission dataset, time points can be represented using the time point variables --TPT, --TPTNUM,-- ELTM. See SDTMIG Section 4.1.4.10 计划时间点编号可能需要用于区分多个连续评估。如果收集，建议在 CRF 上预先打印时间点编号。在 SDTM 提交数据集中，时间点可以使用时间点变量 --TPT, --TPTNUM, --ELTM 表示。请参见 SDTMIG 第 4.1.4.10 节。 |
| Timing 时机 | N/A | 36 | --TPTREF | Time Point Reference 时间点参考 | Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. --ELTM、--TPTNUM 和 --TPT 所提到的固定参考点的描述。 | What is the description of the fixed reference point? 固定参考点的描述是什么？ | [Reference Time Point] [参考时间点] | Char 字符 | --TPTREF | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | Planned reference point referred to by time point variables --TPT, TPTNUM, --ELTM. See SDTMIG Section 4.1.4.10 . This would most commonly be pre-specified on the CRF, and not a question to which the site would provide an answer. 计划参考点由时间点变量 --TPT, TPTNUM, --ELTM 指代。请参见 SDTMIG 第 4.1.4.10 节。这通常会在 CRF 上预先指定，而不是一个由现场提供答案的问题。 |
| Timing 时机 | N/A | 37 | --RFTDAT | Date of the Reference Time Point 参考时间点日期 | Date for a fixed reference time point defined by --TPTREF. 由--TPTREF 定义的固定参考时间点的日期。 | What was the date of the [Reference Time point]? [参考时间点]的日期是什么？ | [Reference Time point] [参考时间点] | Char 字符 | --RFTDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, the SDTMIG variable --RFTDTC is derived by concatenating all collected CDASH --RFTDAT, and --RFTTIM components and populating the SDTM variable --RFTDTC in ISO 8601 format. 该字段不直接映射到 SDTM 变量。对于 SDTM 数据集，SDTMIG 变量--RFTDTC 是通过连接所有收集的 CDASH --RFTDAT 和--RFTTIM 组件，并以 ISO 8601 格式填充 SDTM 变量--RFTDTC 得出的。 | N/A | Date of the fix reference time point defined by --TPTREF. 修复参考时间点由--TPTREF 定义的日期。 |
| Timing 时机 | N/A | 38 | --RFTTIM | Time of the Reference Time Point 参考时间点的时间 | Time for a fixed reference time point defined by --TPTREF. 固定参考时间点由 --TPTREF 定义。 | What was the time of the [Reference Time point]? [参考时间点]是什么时候？ | [Reference Time point] [参考时间点] | Char 字符 | --RFTDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, the SDTMIG variable --RFTDTC is derived by concatenating all collected CDASH --RFTDAT, and --RFTTIM components and populating the SDTM variable --RFTDTC in ISO 8601 format. 该字段不直接映射到 SDTM 变量。对于 SDTM 数据集，SDTMIG 变量--RFTDTC 是通过连接所有收集的 CDASH --RFTDAT 和--RFTTIM 组件，并以 ISO 8601 格式填充 SDTM 变量--RFTDTC 得出的。 | N/A | Time of the fix reference time point defined by --TPTREF. 修复参考时间点由 --TPTREF 定义。 |
| Timing 时机 | N/A | 39 | --CEVINT | Collected Evaluation Interval 收集评估间隔 | The collected or pre-populated text description of an interval associated with an observation such as a finding --TESTCD. 与观察（如发现）相关的区间的收集或预填充文本描述 --TESTCD。 | [Included as part of a protocol specified question] [作为协议规定问题的一部分] | [Evaluation Interval] [评估区间] | Char 字符 | --EVLINT;--EVINTX | This field does not map directly to an SDTM variable. For the SDTM dataset, convert the collect evaluation interval into an ISO 8601 period format and populate the SDTM variable --EVLINT or if the interval can not be converted to an ISO format, populate the SDTM variable --EVINTX. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将收集评估间隔转换为 ISO 8601 期间格式，并填充 SDTM 变量--EVLINT；如果间隔无法转换为 ISO 格式，则填充 SDTM 变量--EVINTX。 | N/A | The CDASH field --CEVINT (which is stored as free text) indicates a period of time during which an observation is being made or about which a question is being asked (e.g., "During the past six months what was the subject average sleep time?" or "Record any significant cardiovascular medical history over the subject lifetime?" The evaluation interval free text is defaulted in the hidden CDASH field --CEVINT (e.g. PAST 6 MONTHS, LIFETIME). Intervals that can be converted to ISO format (e.g., PAST 6 WEEKS), are mapped to the SDTM variable --EVLINT (-P6W), and free text interval are mapped to --EVINTX (LIFETIME). See the SDTMIG Section 4.1.4.3. CDASH 字段--CEVINT（以自由文本形式存储）指示观察进行的时间段或提出问题的时间段（例如，“在过去六个月中，受试者的平均睡眠时间是多少？”或“记录受试者一生中任何重要的心血管病史？”）。评估间隔的自由文本默认存储在隐藏的 CDASH 字段--CEVINT 中（例如，过去 6 个月、一生）。可以转换为 ISO 格式的间隔（例如，过去 6 周）映射到 SDTM 变量--EVLINT（-P6W），而自由文本间隔映射到--EVINTX（LIFETIME）。请参见 SDTMIG 第 4.1.4.3 节。 |
| Timing 时机 | N/A | 40 | --EVLINT | Evaluation Interval 评估区间 | Duration of interval associated with an observation such as a finding --TESTCD. 与观察（如发现）相关的间隔持续时间 --TESTCD。 | N/A | N/A | Char 字符 | --EVLINT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | N/A | The CDASH field --EVLINT indicates a period of time during which an observation is being made or about which a question is being asked which is represented in an ISO format. This would be a hidden field on the CRF or screen, not a question to which the site would provide an answer. The evaluation interval is included in the question text and a hidden CDASH field --EVLINT is defaulted using the appropriate ISO format for the interval (e.g. , "During the past six months what was the subject's average sleep time?" is the question text and the hidden CDASH field --EVLINT would be "-P6M". See the SDTMIG Section 4.1.4.3. CDASH 字段--EVLINT 表示观察进行的时间段或被询问的问题的时间段，以 ISO 格式表示。这将在 CRF 或屏幕上作为隐藏字段，而不是站点需要提供答案的问题。评估时间间隔包含在问题文本中，并且隐藏的 CDASH 字段--EVLINT 使用适当的 ISO 格式默认设置（例如，“在过去六个月中，受试者的平均睡眠时间是多少？”是问题文本，隐藏的 CDASH 字段--EVLINT 将是“-P6M”。请参见 SDTMIG 第 4.1.4.3 节。 |
| Timing 时机 | N/A | 41 | DTHDAT | Date of Death 死亡日期 | Date of death for any subject who died. 任何已故主题的死亡日期。 | What [is/was] the subject's date of death? 被试的死亡日期是什么？ | Death Date 死亡日期 | Char 字符 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor, but should only be collected once. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集，但应仅收集一次。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 42 | DTHDD | Day of Death 死亡日 | Day of death for any subject who died. 任何已故主题的死亡日期。 | What [is/was] the subject's day of death? 被试的死亡日期是什么？ | Death Day 死亡日 | Char 字符 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 43 | DTHMO | Month of Death 死亡月份 | Month of death for any subject who died. 任何去世者的死亡月份。 | What [is/was] the subject's month of death? 受试者的死亡月份是什么？ | Death Month 死亡月 | Char 字符 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 44 | DTHYY | Year of Death 去世年份 | Year of death for any subject who died. 任何去世者的死亡年份。 | What [is/was] the subject's year of death? 被试的死亡年份是什么？ | Death Year 死亡年份 | Char 字符 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 45 | DTHTIM | Time of Death 死亡时间 | Time of death for any subject who died. 任何死亡个体的死亡时间。 | What [is/was] the subject's time of death? 受试者的死亡时间是什么？ | Death Time 死亡时间 | Char 字符 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 46 | DTHHR | Hour of Death 死亡时刻 | Hour of death for any subject who died. 任何死亡个体的死亡时间。 | What [is/was] the subject's hour of death? 受试者的死亡时间是什么时候？ | Hour of Death 死亡时刻 | Num 数字 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
| Timing 时机 | N/A | 47 | DTHMI | Minute of Death 死亡的瞬间 | Minute of death for any subject who died. 任何死亡主题的死亡分钟。 | What [is/was] the subject's minute of death? 受试者的死亡时间是几点？ | Minute of Death 死亡的瞬间 | Num 数字 | DM.DTHDTC | This field does not map directly to an SDTM variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DM.DTHDTC in ISO 8601 format. 该字段不能直接映射到 SDTM 变量。对于 SDTM 数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 DM.DTHDTC。 | N/A | The CDASH model defines Death Date as a timing variable. It is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the Sponsor. The SDTM variable DTHDTC and DTHFL are mapped to the DM domain during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS). CDASH 模型将死亡日期定义为一个时间变量。在 SDTMIG 中未将其作为时间变量包含。它可以在赞助商认为合适的任何 CRF 上收集。在 SDTM 提交数据集创建过程中，SDTM 变量 DTHDTC 和 DTHFL 被映射到 DM 领域。死亡日期可以根据赞助商的判断映射到其他 SDTM 领域（例如，DS）。 |
2.6 Special Purpose 2.6 特殊目的
Special Purpose 特殊目的
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Special-Purpose 专用 | CO | 1 | COVAL | [domain specific label] [领域特定标签] | A free text comment. 免费文本评论。 | [Protocol -specified Targeted Question]? [协议指定的针对性问题]? | [abbreviated version of the protocol-specified targeted question] [协议规定的目标问题的简化版本] | Char 字符 | CO.COVAL | This does not map directly to an SDTM variable. For the SDTM dataset, the CDASH variable COVAL maps to the SDTM variable COVAL (COVAL2, COVAL3) in the CO domain. Associate the free text comment in the CO domain with the original record using RDOMAIN, IDVAR, IDVARVAL, COREF. 这并不直接映射到 SDTM 变量。对于 SDTM 数据集，CDASH 变量 COVAL 映射到 CO 域中的 SDTM 变量 COVAL（COVAL2，COVAL3）。使用 RDOMAIN、IDVAR、IDVARVAL、COREF 将 CO 域中的自由文本评论与原始记录关联起来。 | N/A | If an additional free text field is needed to provide a comment about a particular record, use the COVAL(n) field to collect the free text, and associate the free text comment with the original record using SDTM variables RDOMAIN, IDVAR, IDVARVAL, COREF. See the SDTMIG for more information. 如果需要额外的自由文本字段来提供关于特定记录的评论，请使用 COVAL(n) 字段收集自由文本，并使用 SDTM 变量 RDOMAIN、IDVAR、IDVARVAL、COREF 将自由文本评论与原始记录关联。有关更多信息，请参见 SDTMIG。 |
| Special-Purpose 专用 | DM | 1 | SITEID | Study Site Identifier 研究地点标识符 | Unique identifier for a site within a study 研究中一个站点的唯一标识符 | What is the site identifier? 网站标识符是什么？ | Site Identifier 站点标识符 | Char 字符 | SITEID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | N/A | N/A |
| Special-Purpose 专用 | DM | 2 | INVID | Investigator Identifier 调查员标识符 | An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID. 一个用于描述研究者的标识符。可以与 SITEID 一起使用。如果 SITEID 等同于 INVID，则不需要。 | What is the investigator identifier? 调查员标识符是什么？ | Investigator Identifier 调查员标识符 | Char 字符 | INVID | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | N/A | N/A |
| Special-Purpose 专用 | DM | 3 | INVNAM | Investigator Name 调查员姓名 | The name of investigator for a site. 现场调查员的姓名。 | What is the investigator's name? 调查员的名字是什么？ | Investigator Name 调查员姓名 | Char 字符 | INVNAM | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | N/A | N/A |
| Special-Purpose 专用 | DM | 4 | RFICDAT | Date of Informed Consent 知情同意日期 | The date the informed consent is signed in an unambiguous date format. 知情同意书签署的日期应以明确的日期格式表示。 | What date did the subject sign informed consent? 受试者在什么日期签署了知情同意书？ | Informed Consent Date 知情同意日期 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 5 | RFICDD | Day of Informed Consent 知情同意日 | Day informed consent signed in an unambiguous date format. (e.g., DD). 以明确的日期格式签署的日常知情同意书。（例如，DD）。 | What day did the subject sign informed consent? 受试者在哪一天签署了知情同意书？ | Informed Consent Day 知情同意日 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 6 | RFICMO | Month of Informed Consent 知情同意月 | Month informed consent signed in an unambiguous date format. (e.g., MON). 月份知情同意书以明确的日期格式签署。（例如，MON）。 | What month did the subject sign informed consent? 受试者在哪个月签署了知情同意书？ | Informed Consent Month 知情同意月 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 7 | RFICYY | Year of Informed Consent 知情同意年 | Year informed consent signed in an unambiguous date format. (e.g., YYYY) 年份以明确的日期格式签署知情同意书。（例如：YYYY） | What year did the subject sign informed consent? 受试者在哪一年签署了知情同意书？ | Informed Consent Year 知情同意年 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 8 | RFICTIM | Time of Informed Consent 知情同意的时间 | Time informed consent signed in an unambiguous date format (e.g., hh:mm). 时间知情同意书以明确的日期格式签署（例如：hh:mm）。 | What time did the subject sign informed consent? 受试者在什么时间签署了知情同意书？ | Informed Consent Time 知情同意时间 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 9 | RFICHR | Hour of Informed Consent 知情同意的时刻 | Hour informed consent signed in an unambiguous time format (e.g., hh). 明确时间格式（例如，hh）签署的小时知情同意书。 | What hour did the subject sign informed consent? 受试者在什么时间签署了知情同意书？ | Informed Consent Hour 知情同意时间 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 10 | RFICMI | Minute of Informed Consent 知情同意书的记录 | Minute informed consent signed in an unambiguous time format (e.g., mm). 明确的时间格式（例如，mm）签署的分钟知情同意书。 | What minute did the subject sign informed consent? 受试者在第几分钟签署了知情同意书？ | Informed Consent Minute 知情同意记录 | Char 字符 | RFICDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RFICDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 RFICDTC。 | N/A | This will be the same information on informed consent used in the SDTM Disposition Domain 这将是 SDTM 处置领域中使用的知情同意的相同信息 |
| Special-Purpose 专用 | DM | 11 | BRTHDAT | Date of Birth 出生日期 | A subject's date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day and Birth Time. 受试者的出生日期（包括或不包括出生时间）。完整的出生日期由出生年份、出生月份、出生日期和出生时间的时间成分组成。 | What [is/was] the subject's date of birth? 被试的出生日期是什么？ | Birth Date 出生日期 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 12 | BRTHDD | Day of Birth 出生日期 | Day of birth of the subject in an unambiguous date format (e.g., DD). 受试者的出生日期以明确的日期格式表示（例如，DD）。 | What [is/was] the subject's day of birth? 被试的出生日期是什么？ | Birth Day 生日 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 13 | BRTHMO | Month of Birth 出生月份 | Day of birth of the subject in an unambiguous date format (e.g., DD). 受试者的出生日期以明确的日期格式表示（例如，DD）。 | What [is/was] the subject's month of birth? 受试者的出生月份是什么？ | Birth Month 出生月份 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 14 | BRTHYY | Year of Birth 出生年份 | The year of birth of the subject in an unambiguous date format (e.g., YYYY). 受试者的出生年份以明确的日期格式表示（例如：YYYY）。 | What [is/was] the subject's year of birth? 受试者的出生年份是什么？ | Birth Year 出生年份 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 15 | BRTHHR | Hour of Birth 出生时间 | The hour of birth of the subject in an unambiguous time format (e.g., hh). 受试者的出生时间以明确的时间格式表示（例如，hh）。 | What [is/was] the subject's hour of birth? 被试的出生时间是什么时候？ | Birth Hour 出生时间 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 16 | BRTHMI | Minute of Birth 出生分钟 | The minute of birth of the subject in an unambiguous time format (e.g., mm). 出生时刻的分钟，以明确的时间格式表示（例如，mm）。 | What [is/was] the subject's minute of birth? 受试者的出生分钟是什么？ | Birth Minute 出生分钟 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 17 | BRTHTIM | Time of Birth 出生时间 | The time of birth of the subject in an unambiguous time format (e.g., hh:mm). 受试者的出生时间以明确的时间格式表示（例如，hh:mm）。 | What [is/was] the subject's time of birth? 被试的出生时间是什么时候？ | Birth Time 出生时间 | Char 字符 | BRTHDTC | This does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable BRTHDTC in ISO 8601 format. 这并不直接映射到 SDTM 变量。对于 SDTM 提交数据集，将所有收集的 CDASH 日期和时间组件连接起来，并以 ISO 8601 格式填充 SDTM 变量 BRTHDTC。 | N/A | N/A |
| Special-Purpose 专用 | DM | 18 | AGE | Age 年龄 | The age of the subject expressed in AGEU. 被试的年龄以 AGEU 表示。 | What [is/was] the subject's age? 受试者的年龄是多少？ | Age 年龄 | Num 数字 | AGE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | N/A | If Age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the Age Unit. It may be necessary to know when the age was collected as an age may need to be recalculated for analysis, such as deriving age at a reference start time (RFSTDTC for SDTM). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit. 如果收集年龄，应该以数字形式收集，并且为了正确解释，年龄值应与年龄单位的变量相关联。可能需要知道年龄收集的时间，因为在分析时可能需要重新计算年龄，例如在参考开始时间（SDTM 的 RFSTDTC）推导年龄。BRTHDTC 在所有情况下可能不可用（由于受试者隐私问题）。如果收集了年龄，建议同时记录收集日期，可以单独记录或与访问日期关联。 |
| Special-Purpose 专用 | DM | 19 | AGEU | Age Units 年龄单位 | Those units of time that are routinely used to express the age of a person. 那些常用来表示一个人年龄的时间单位。 | What [is/was] the age unit used? 使用的年龄单位是什么？ | Age Unit 年龄单位 | Char 字符 | AGEU | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | (AGEU) （AGEU） | If Age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of "years"). 如果在 CRF 上记录了年龄，则必须知道年龄单位以使年龄值有意义。年龄单位可能在 CRF 上收集，在协议允许任何年龄组的情况下，或者可能预先印刷在 CRF 上（通常单位为“岁”）。 |
| Special-Purpose 专用 | DM | 20 | SEX | Sex 性 | Sex of the subject as determined by the investigator. 受试者的性别由研究者确定。 | What [is/was] the sex of the subject? 该对象的性别是什么？ | Sex 性 | Char 字符 | SEX | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | (SEX) (性) | Collect the subject's sex or gender, as reported by subject or caretaker. This is a phenotypic assessment and not a genotypic assessment. 收集受试者的性别或性别认同，由受试者或看护人报告。这是表型评估，而不是基因型评估。 |
| Special-Purpose 专用 | DM | 21 | RACE | Race 种族 | An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control). 基于物理特征的任意分类；由共同血统或遗传关系相关联的一群人（美国疾病控制与预防中心）。 | Which of the following five racial designations best describes you? (More than one choice is acceptable.) 以下五个种族类别中，哪个最能描述您？（可以选择多个选项。） | Race 种族 | Char 字符 | RACE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | (RACE) （比赛） | Use RACE when the five designations for race used by the FDA are collected (American Indian or Alaska Native; Asian; Black or African American*; Native Hawaiian or Other Pacific Islander ; White) . *For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. RACE1, RACE2) and populate RACE with the value MULTIPLE. Sponsors should refer to the "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, September 2016). See the SDTMIG Section 5-DM Domain. 在收集 FDA 使用的五个种族分类（美洲印第安人或阿拉斯加土著；亚洲人；黑人或非裔美国人*；夏威夷土著或其他太平洋岛民；白人）时使用 RACE。*对于在美国以外收集数据的研究，推荐的分类相同，只是将黑人改为黑人或非裔美国人。如果收集了多个种族，则需要一个替代的赞助商定义的变量结构。赞助商可以通过附加后缀来记录受试者的多个自我报告种族，以表示收集的多个种族（例如 RACE1，RACE2），并将 RACE 填充为 MULTIPLE。赞助商应参考“临床试验中的种族和民族数据收集”（FDA，2016 年 9 月）。请参见 SDTMIG 第 5 节-DM 领域。 |
| Special-Purpose 专用 | DM | 22 | CRACE | Collected Race 收集的比赛 | An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control). 基于物理特征的任意分类；由共同血统或遗传关系相关联的一群人（美国疾病控制与预防中心）。 | Which of the following racial designations best describes you? (More than one choice is acceptable.) 以下哪个种族称谓最能描述您？（可以选择多个选项。） | Race 种族 | Char 字符 | SUPPDM.QVAL | This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race". See the SDTMIG Section for the DM Domain. 这并不直接映射到 SDTMIG 变量。该信息可以作为 SUPPDM.QVAL 的值提交到 SUPPDM 数据集中，当 SUPPDM.QNAM = "CRACE"且 SUPPDM.QLABEL = "收集的种族"时。请参阅 DM 领域的 SDTMIG 部分。 | (RACEC) （RACEC） | Use CRACE when more detailed race categorizations are desired (e.g. more than the five minimum designations for race used by the FDA). The use of race and vocabulary tables located within Health Level Seven's Reference Information Model Structural Vocabulary Tables is recommended, as they are designed to collapse up to the SDTM variable RACE with CT (e.g., American Indian or Alaska Native Asian; Black or African American*; Native Hawaiian or Other Pacific Islander; White ). *For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. CRACE1, CRACE2) and populate CRACE with the value MULTIPLE. If sponsors choose to map the extended Race codelist values to the RACE CT (e.g. Japanese to Asian ), then this mapped variable would be reported using the SDTMIG variable RACE. Sponsors should refer to the "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, September 2016). 在需要更详细的种族分类时使用 CRACE（例如，超过 FDA 使用的五个最低种族分类）。建议使用健康水平七的参考信息模型结构词汇表中的种族和词汇表，因为它们旨在将最多 SDTM 变量 RACE 与 CT 合并（例如，美国印第安人或阿拉斯加土著亚洲人；黑人或非裔美国人*；夏威夷土著或其他太平洋岛民；白人）。*对于在美国以外收集数据的研究，推荐的分类相同，只是将黑人替换为黑人或非裔美国人。如果收集了多个种族，则需要一个替代的赞助商定义的变量结构。赞助商可以通过附加后缀来记录受试者的多个自我报告种族，以表示收集的多个种族（例如，CRACE1，CRACE2），并将 CRACE 填充为 MULTIPLE。如果赞助商选择将扩展的种族代码列表值映射到 RACE CT（例如，将日本人映射为亚洲人），则该映射变量将使用 SDTMIG 变量 RACE 报告。 赞助商应参考《临床试验中的种族和民族数据收集》（FDA，2016 年 9 月）。 |
| Special-Purpose 专用 | DM | 23 | ETHNIC | Ethnicity 民族 | A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. 一个以独特的社会和文化传统为特征的社会群体，这种传统代代相传，具有共同的历史和起源，以及对该群体的认同感；该群体的成员在生活方式、共同经历上具有独特的特征，通常还有共同的遗传遗产；这些特征可能反映在他们的健康和疾病体验中。 | Do you consider yourself Hispanic/Latino or not Hispanic/Latino? 您认为自己是西班牙裔/拉丁裔还是非西班牙裔/拉丁裔？ | Ethnicity 民族 | Char 字符 | ETHNIC | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | (ETHNIC) （民族） | For use when values are being collected using the exact non-extensible ETHNIC codelist (C66790) values. Sponsors should refer to "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, September 2016) for guidance regarding the collection of ethnicity (http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-gen/documents/document/ucm126396.pdf) 在使用精确的不可扩展的 ETHNIC 代码列表（C66790）值收集数据时使用。赞助商应参考“临床试验中的种族和民族数据收集”（FDA，2016 年 9 月）以获取有关收集民族的指导（http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-gen/documents/document/ucm126396.pdf） |
| Special-Purpose 专用 | DM | 24 | CETHNIC | Collected Ethnicity 收集的民族性 | A social group characterized by a distinctive social and cultural tradition that is maintained from generation to generation. Members share a common history and origin and a sense of identification with the group. They have similar and distinctive features in their lifestyle habits and shared experiences. They often have a common genetic heritage which may be reflected in their experience of health and disease. When submitting to the FDA, the collected values must be rolled up to the permissible values in ETHNIC. 一个以独特的社会和文化传统为特征的社会群体，这种传统代代相传。成员们共享共同的历史和起源，并对该群体有认同感。他们在生活习惯和共同经历上有相似且独特的特征。他们通常有共同的遗传遗产，这可能在他们的健康和疾病经历中有所体现。在向 FDA 提交时，收集的数值必须汇总为 ETHNIC 中的允许值。 | What [is/was] the ethnicity of the subject? 该主题的民族是什么？ | Ethnicity 民族 | Char 字符 | SUPPDM.QVAL | This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL = "Collected Ethnicity". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPPDM.QVAL 的值提交到 SUPPDM 数据集中，当 SUPPDM.QNAM = "CETHNIC"且 SUPPDM.QLABEL = "收集的种族"时。有关在 SDTM 领域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | (ETHNICC) | Use when values are collected using the NCI Thesaurus codelist for Ethnicity As Collected (C128690), the extended HL7 hierarchy of codelist values, or other Regulatory Agency specific controlled terminology for Ethnic Group. Sponsors may append a suffix to denote multiple collected ethnicities (e.g. CETHNIC1, CETHNIC2). 在使用 NCI 术语表的收集的种族代码列表（C128690）、扩展的 HL7 代码列表值层次结构或其他监管机构特定的受控术语来收集值时使用。赞助商可以附加后缀以表示多种收集的种族（例如 CETHNIC1，CETHNIC2）。 |
| Special-Purpose 专用 | DM | 25 | AGETXT | Age Text 年龄文本 | The age of the subject at study start expressed as an range. 研究开始时受试者的年龄以范围表示。 | What [is/was] the subject's age (range)? 受试者的年龄（范围）是多少？ | Age (Range) 年龄（范围） | Char 字符 | AGETXT | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target" . 直接映射到“SDTM 目标”列中列出的 SDTM 变量。 | N/A | If an numeric age value is available, then populate the AGE variable instead. Either the AGE or AGETXT field should be populated, not both. See the CDASHIG for more information. 如果有可用的数字年龄值，则应填充 AGE 变量。应填充 AGE 或 AGETXT 字段，而不是两者。有关更多信息，请参见 CDASHIG。 |
| Special-Purpose 专用 | DM | 26 | CAGETXT | Collected Age Text 收集的年龄文本 | The age of the subject at study start expressed as descriptive text and not a range. 研究开始时受试者的年龄以描述性文本形式表达，而不是以范围。 | What [is/was] the subject's age (description)? 受试者的年龄（描述）是什么？ | Age (Description) 年龄（描述） | Char 字符 | AGETXT; SUPPDM.QVAL | If the collected value is a range, then the result maps directly to AGETXT. If the collected is value is a description, the result maps to SUPPDM.QVAL where SUPPDM.QNAM = "CAGETXT" and SUPPDM.QLABEL = "Collected Age Text". 如果收集的值是一个范围，则结果直接映射到 AGETXT。如果收集的值是一个描述，则结果映射到 SUPPDM.QVAL，其中 SUPPDM.QNAM = "CAGETXT"且 SUPPDM.QLABEL = "收集的年龄文本"。 | N/A | If only collected age ranges (e.g., 0-3, 18 -25, >65) are expected, those should be collected using AGETXT. If collecting age descriptions (e.g., Neonate, Adolescent, Adult), those must be collected using CAGETXT. 如果只期望收集年龄范围（例如，0-3 岁，18-25 岁，>65 岁），则应使用 AGETXT 进行收集。如果收集年龄描述（例如，新生儿、青少年、成人），则必须使用 CAGETXT 进行收集。 |
2.7 Domain-Specific 2.7 领域特定
Domain-Specific 领域特定
| Observation Class 观察课 | Domain 域名 | Order Number 订单号码 | CDASH Variable CDASH 变量 | CDASH Variable Label CDASH 变量标签 | DRAFT CDASH Definition 草案 CDASH 定义 | Question Text 问题文本 | Prompt 提示 | Data Type 数据类型 | SDTM Target SDTM 目标 | Mapping Instructions 映射说明 | Controlled Terminology Codelist Name 受控术语代码列表名称 | Implementation Notes 实施说明 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Domain Specific 领域特定 | AE | 1 | AEACNOYN | Any Other Actions Taken 采取的其他行动 | An indication whether any other action(s) were taken in response to the adverse event that are unrelated to study treatment dose changes or other non-study treatments given because of this adverse event. 是否采取了与研究治疗剂量变化或因该不良事件而给予的其他非研究治疗无关的任何其他措施，以应对该不良事件的指示。 | Were any other actions taken in response to this adverse event? 对此不良事件是否采取了其他措施？ | Any Other Actions Taken 采取的其他行动 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the AEACNOTH field on the CRF was deliberately left blank. 收集此字段的意图/目的在于帮助数据清理和监控。它提供了对 CRF 上 AEACNOTH 字段故意留空的验证。 |
| Domain Specific 领域特定 | AE | 2 | AERLNSYN | Related to Non-Study Treatment 与非学习治疗相关 | An indication whether in the investigator's opinion the event may have been due to a treatment other than study treatment. 一个指示，表明调查员认为该事件可能是由于研究治疗以外的其他治疗引起的。 | [Is/Was] this adverse event due to treatment other than study treatment? 该不良事件是否由于研究治疗以外的治疗引起？ | Related to Non-Study Treatment 与非学习治疗相关 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the CDASH AERELNST field on the CRF was deliberately left blank. 收集此字段的意图/目的在于帮助数据清理和监控。它提供了验证，确认 CRF 上的 CDASH AERELNST 字段是故意留空的。 |
| Domain Specific 领域特定 | AE | 3 | AESCAN | Involves Cancer 涉及癌症 | An indication the serious event was associated with the development of cancer. 一个迹象表明这一严重事件与癌症的发展有关。 | [Is/Was] the adverse event associated with the development of cancer? 该不良事件是否与癌症的发展有关？ | Cancer 癌症 | Char 字符 | AESCAN | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | Although deprecated, this variable is included for illustrative purposes if the sponsor is continuing to collect legacy data. If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 尽管已被弃用，但该变量仍然包含在内，以便在赞助商继续收集遗留数据时进行说明。如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。注意：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 4 | AESCONG | Congenital Anomaly or Birth Defect 先天性畸形或出生缺陷 | An indication the serious adverse event was associated with a congenital anomaly or birth defect. 一个迹象表明严重不良事件与先天性畸形或出生缺陷有关。 | [Is/Was] the adverse event associated with a congenital anomaly or birth defect? 该不良事件是否与先天性畸形或出生缺陷有关？ | Congenital Anomaly/Birth Defect 先天性畸形/出生缺陷 | Char 字符 | AESCONG | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 5 | AESDISAB | Disability or Permanent Damage 残疾或永久性损伤 | An indication the serious adverse event was associated with a persistent or significant disability or incapacity. 一个迹象表明，严重不良事件与持续或显著的残疾或失能有关。 | Did the adverse event result in disability or permanent damage? 不良事件是否导致残疾或永久性损伤？ | Disability or Permanent Damage 残疾或永久性损伤 | Char 字符 | AESDISAB | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. his information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 6 | AESDTH | Results in Death 导致死亡 | An indication the serious adverse event resulted in death. 严重不良事件导致死亡的迹象。 | Did the adverse event result in death? 不良事件是否导致死亡？ | Death 死亡 | Char 字符 | AESDTH | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015). Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）。第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 7 | AESHOSP | Initial or Prolonged Hospitalization 初次或延长住院 | An indication the serious adverse event resulted in an initial or prolonged hospitalization. 严重不良事件导致初次或延长住院的迹象。 | Did the adverse event result in initial or prolonged hospitalization of the subject? 不良事件是否导致受试者最初或延长住院？ | Hospitalization (initial or prolonged) 住院（初次或延长） | Char 字符 | AESHOSP | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 8 | AESI | Adverse Event of Special Interest 特殊关注的不良事件 | An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g., regulators) might also be warranted. 特殊关注的不良事件（严重或非严重）是指与赞助商的产品或项目相关的科学和医学关注事项，研究者对其进行持续监测并迅速与赞助商沟通是合适的。这种事件可能需要进一步调查，以便对其进行特征描述和理解。根据事件的性质，试验赞助商也可能需要迅速与其他相关方（例如，监管机构）进行沟通。 | [Is/Was] this event of special interest? 这个事件是否特别有趣？ | Adverse Event of Special Interest 特殊关注的不良事件 | Char 字符 | N/A | Does not map to an SDTM variable. The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED. 不映射到 SDTM 变量。SDTM 注释 CRF 已注释以指示此字段未提交。 | (NY) （纽约） | This CDASH field may be used just to trigger other CRF pages, or populate a value in AECAT or AESCAT. If submitted, this information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM= "AESI" and SUPP--.QLABEL = "Adverse Event of Special Interest". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 此 CDASH 字段可用于触发其他 CRF 页面，或在 AECAT 或 AESCAT 中填充值。如果提交，此信息可以在 SUPP--.QVAL 数据集中提交，其中 SUPP--.QNAM = "AESI" 和 SUPP--.QLABEL = "特殊关注的不良事件"。有关在 SDTM 领域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 |
| Domain Specific 领域特定 | AE | 9 | AESINTV | Requires Intervention Device 需要干预设备 | An indication a serious adverse event required medical or surgical intervention to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, due to the use of a medical product. 一个指示，严重不良事件需要医疗或外科干预，以防止身体功能的永久性损害或防止身体结构的永久性损伤，因使用医疗产品而导致。 | Did the adverse event require intervention to prevent permanent impairment or damage due to the use of a medical product? 该不良事件是否需要干预以防止因使用医疗产品而导致的永久性损伤或损害？ | Required Intervention 必要的干预 | Char 字符 | SUPPAE.QVAL | This does not map directly to an SDTM variable. Sponsors should see requirements for the reporting of adverse events involving medical devices. 这并不直接对应于 SDTM 变量。赞助商应查看涉及医疗设备的不良事件报告的要求。 | (NY) （纽约） | This criteria is used for serious adverse events associated with a medical product (e.g., device). SDTM does not contain a variable to report this criteria of seriousness. Sponsor could submit this in the SUPPAE dataset. Sponsors should see requirements for the reporting of adverse events involving medical devices to health authorities. 该标准用于与医疗产品（例如设备）相关的严重不良事件。SDTM 中没有变量来报告这一严重性标准。赞助商可以在 SUPPAE 数据集中提交此信息。赞助商应查看向卫生当局报告涉及医疗设备的不良事件的要求。 |
| Domain Specific 领域特定 | AE | 10 | AESLIFE | Is Life Threatening 生命是否有威胁 | An indication the serious adverse event was life threatening. 该严重不良事件的指示是危及生命的。 | [Is/Was] the adverse event life threatening? 该不良事件是否危及生命？ | Life Threatening 危及生命 | Char 字符 | AESLIFE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 11 | AESMIE | Other Medically Important Serious Event 其他医学重要严重事件 | An indication additional categories for seriousness apply. 额外的严重性类别适用。 | [Is/Was] the adverse event a medically important event not covered by other "serious" criteria? 该不良事件是否是一个医学上重要的事件，而不符合其他“严重”标准？ | Other Serious (Important Medical Events) 其他严重（重要医疗事件） | Char 字符 | AESMIE | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 如果在临床数据库中收集了严重不良事件的详细信息，则建议为每种严重不良事件类型定义一个单独的是/否变量。给赞助商的注意事项：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集到该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间对于支持严重不良事件的特征化至关重要。” |
| Domain Specific 领域特定 | AE | 12 | AESOD | Occurred with Overdose 发生了过量服用 | An indication the serious event occurred with an overdose. 一个迹象表明发生了严重事件，伴随过量服用。 | Did the adverse event occur with an overdose? 不良事件是否因过量服用而发生？ | Overdose 过量服用 | Char 字符 | AESOD | Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 直接映射到标题为“SDTM 目标”的列中列出的 SDTM 变量。 | (NY) （纽约） | Although deprecated, this variable is included for illustrative purposes if the sponsor is continuing to collect legacy data. If the details regarding a Serious AE are collected in the clinical database, then it is recommended that a separate Yes/No variable. Note for sponsors: The FDA Study Data Technical Conformance Guide v2.2 (June 12, 2015) Section 4.1.1.3 states "The entry of a "Y" for the serious adverse event variable, AESER, should have the assessment indicated, (e.g., as a death, hospitalization, or disability/permanent damage). Frequently, sponsors omit the assessment information, even when it has been collected on the CRF. The criteria that led to the determination should be provided. This information is critical during FDA review to support the characterization of serious AEs". 尽管已被弃用，但该变量仍然包含在内，以便在赞助商继续收集遗留数据时进行说明。如果在临床数据库中收集了严重不良事件的详细信息，则建议使用单独的是/否变量。注意：FDA 研究数据技术一致性指南 v2.2（2015 年 6 月 12 日）第 4.1.1.3 节指出：“在严重不良事件变量 AESER 中输入‘Y’时，应指明评估（例如，作为死亡、住院或残疾/永久性损伤）。赞助商经常省略评估信息，即使在 CRF 上已收集该信息。应提供导致该判断的标准。这些信息在 FDA 审查期间至关重要，以支持对严重不良事件的描述。” |
| Domain Specific 领域特定 | DS | 1 | DSCONT | Subject Continue 主题继续 | The plan for subject continuation to the next phase of the study or another study at the time of completion of the CRF. 在完成 CRF 时，关于受试者继续进入研究下一阶段或其他研究的计划。 | Will the subject continue? 主题会继续吗？ | Subject Continue 主题继续 | Char 字符 | SUPPDS.QVAL | This information could be submitted in a SUPPDS dataset as the value of SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 该信息可以作为 SUPPDS.QVAL 的值提交到 SUPPDS 数据集中，当 SUPPDS.QNAM="DSCONT"且 SUPPDS.QLABEL="Subject Continue"时。有关在 SDTM 领域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 | (NY) （纽约） | N/A |
| Domain Specific 领域特定 | DS | 2 | DSNEXT | Next EPOCH 下一个时代 | Identifies the study epoch or new study in which the subject will participate. 确定受试者将参与的研究时期或新研究。 | What [is/was] the next [Period/Epoch/ Trial] the subject will [continue to/enter/enroll]) ? 该主题将进入下一个阶段是什么？ | Next [Period, Epoch or Trial] 下一个[时期、时代或试验] | Char 字符 | N/A | This variable does not map to an SDTM variable. The CRF is annotated to indicate that this field is NOT SUBMITTED. 该变量不对应于 SDTM 变量。CRF 已标注以指示该字段未提交。 | N/A | Typically this is used as General prompt question to aid in monitoring, data cleaning and subject tracking. This information could be submitted in a SUPP--.QVAL dataset where SUPP--.QNAM = "--DSNEXT" and SUPP--.QLABEL = "Next EPOCH". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains. 通常这被用作一般提示问题，以帮助监控、数据清理和主题跟踪。这些信息可以提交在一个 SUPP--.QVAL 数据集中，其中 SUPP--.QNAM = "--DSNEXT" 和 SUPP--.QLABEL = "下一个 EPOCH"。有关在 SDTM 域中放置非标准变量的说明，请参阅当前的 SDTM 和 SDTMIG。 |
| Domain Specific 领域特定 | DS | 3 | DSUNBLND | Unblinded 未盲化 | An indication the subject's treatment information was revealed to any unauthorized site personnel during the trial. 在试验期间，表明受试者的治疗信息被透露给任何未经授权的现场人员。 | [Is/Was] treatment (unblinded/unmasked) by the site? 治疗是否由现场进行（未盲法/未遮蔽）？ | Unblinded 未盲化 | Char 字符 | DSTERM | This does not map directly to an SDTM variable. If the CDASH field DSUNBLIND = "Y", then the SDTMIG variables DSDECOD and DSTERM = "TREATMENT UNBLINDED" and "DSCAT" = "OTHER EVENT". If DSUNBLIND = "N", then the CRF should be annotated to indicate that this value is NOT SUBMITTED. 这并不直接映射到 SDTM 变量。如果 CDASH 字段 DSUNBLIND = "Y"，则 SDTMIG 变量 DSDECOD 和 DSTERM 分别为"TREATMENT UNBLINDED"和"DSCAT" = "OTHER EVENT"。如果 DSUNBLIND = "N"，则 CRF 应注释以指示该值未提交。 | (NY) （纽约） | There may be multiple rows in the SDTM DS dataset to represent this information; each with the appropriate DSCAT values. One row could indicate the treatment was unblinded using DSCAT="OTHER EVENT" and another row could indicate the status of the subject at the end of their participation in the trial using DSCAT= "DISPOSTION". If DSUNBLND is yes and information was collected about the reason for the unblinding, populate DSCAT with "OTHER EVENT" and the SDTMIG variables DSTERM with the free text and DSDECOD with the sponsor-defined standardized text (e.g., TREATMENT UNBLINDED). If DSUNBLND is yes, and the unblinding also resulted in the subject discontinuing the trial prematurely, populate DSCAT with "DISPOSTION" and use the SDTM IG variables DSTERM and DSDECOD to capture the applicable discontinuation details. If the unblinding occurred due to an Adverse Event, DSTERM contains the text of the Adverse Event, and in the AE domain the SDTMIG variable AEACNOTH "Were any other actions taken in response to this adverse event?" may include text of "Treatment Unblinded". DSUNBLND may also be used to document intentional unblinding at a protocol defined point in the trial. 在 SDTM DS 数据集中可能有多行来表示这些信息；每行都有适当的 DSCAT 值。一行可以表示治疗是开放标签的，使用 DSCAT="OTHER EVENT"，另一行可以表示受试者在参与试验结束时的状态，使用 DSCAT="DISPOSITION"。如果 DSUNBLND 为是，并且收集了关于开放标签原因的信息，则将 DSCAT 填入"OTHER EVENT"，SDTMIG 变量 DSTERM 填入自由文本，DSDECOD 填入赞助商定义的标准化文本（例如，TREATMENT UNBLINDED）。如果 DSUNBLND 为是，并且开放标签还导致受试者提前退出试验，则将 DSCAT 填入"DISPOSITION"，并使用 SDTM IG 变量 DSTERM 和 DSDECOD 来捕捉适用的退出细节。如果开放标签是由于不良事件引起的，DSTERM 包含不良事件的文本，在 AE 领域，SDTMIG 变量 AEACNOTH"是否采取了其他措施应对该不良事件？"可能包括"治疗开放标签"的文本。DSUNBLND 也可以用于记录在试验中协议定义的特定时间点的故意开放标签。 |
| Domain Specific 领域特定 | MH | 1 | MHEVDTYP | Medical History Event Date Type 医疗历史事件日期类型 | Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. 指定了通过 MHSTDTC 和/或 MHENDTC 定义的医疗状况或事件的方面。 | What was the medical history event date type? 医疗历史事件的日期类型是什么？ | Medical History Event Date Type 医疗历史事件日期类型 | Char 字符 | SUPPMH.QVAL | This field does not map directly to an SDTM variable. This information could be submitted in a SUPPMH dataset as the value of SUPPMH.QVAL when SUPPMH.QNAM = "MHEVDTYP" and SUPPMH.QLABEL= "Medical History Event Date Type". 该字段不能直接映射到 SDTM 变量。此信息可以作为 SUPPMH.QVAL 的值提交到 SUPPMH 数据集中，当 SUPPMH.QNAM = "MHEVDTYP"且 SUPPMH.QLABEL = "医疗历史事件日期类型"时。 | N/A | It is not related to the trials condition. It cannot be a value of PRIMARY DIAGNOSIS, SECONDARY DIAGNOSIS). The event date type may the date of DIAGNOSIS, SYMPTOMS, RELAPSE, INFECTION 这与试验条件无关。它不能是主要诊断或次要诊断的值。事件日期类型可以是诊断、症状、复发、感染的日期。 |
Appendices 附录
Appendix A: Representations and Warranties, Limitations of Liability, and Disclaimers
附录 A：陈述与保证、责任限制和免责声明
CDISC Patent Disclaimers CDISC 专利免责声明
It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention.
实施和遵守本标准可能需要使用受专利权保护的主题。发布本标准并不表明对与之相关的任何权利要求或专利权的存在或有效性持有任何立场。CDISC，包括 CDISC 董事会，不对识别实施本标准可能需要许可的专利权利要求负责，也不对其注意到的专利或专利权利要求的法律有效性或范围进行调查。
Representations and Warranties
陈述和保证
"CDISC grants open public use of this User Guide (or Final Standards) under CDISC's copyright."
CDISC 授予公众开放使用本用户指南（或最终标准）的权利，受 CDISC 版权保护。
Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant's ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy ("the Policy")); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants.
每个参与制定本标准的参与者在其贡献（或其代表）时应被视为声明、保证和承诺，尽其所知和能力：（a）其拥有或有权授予在其拥有相关知识产权的所有司法管辖区或地区对其所有贡献的相关许可；（b）参与者在此所作的授予、确认和协议没有限制；以及（c）该贡献不使任何贡献、草案标准、最终标准或其实施的全部或部分，受到与本政策中规定的许可义务不一致的额外限制或要求，或要求任何此类贡献、最终标准或实施的全部或部分：（i）以源代码形式披露或分发；（ii）为制作衍生作品而许可（除非如 CDISC 知识产权政策（“政策”）第 4.2 节所述）；或（iii）免费分发，除非如第 3、5.1 和 4 节所述。政策第 2 条。如果参与者知道任何参与者或其他方所作的贡献可能使任何贡献、草案标准、最终标准或实施的全部或部分受到第 9.3 节中列出的一个或多个许可义务的约束，该参与者应及时通知 CDISC 主席，主席应及时通知所有参与者。
No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT STANDARDS, ARE PROVIDED "AS IS" WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL, FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION.
没有其他担保/免责声明。所有参与者承认，除非根据 CDISC 知识产权政策第 9.3 节的规定，所有草案标准和最终标准，以及对最终标准和草案标准的所有贡献，均按“原样”提供，且不提供任何形式的担保，无论是明示、暗示、法定或其他，参与者、代表、CDISC 总裁、CDISC 董事会及 CDISC 明确否认任何关于适销性、非侵权、特定或预期用途的适用性或任何其他因任何提案、最终标准或草案标准或贡献而产生的担保。
Limitation of Liability 责任限制
IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
在任何情况下，CDISC 或其任何组成部分（包括但不限于 CDISC 董事会、CDISC 总裁、CDISC 员工和 CDISC 成员）对任何其他个人或实体不承担因本政策或任何相关协议而产生的利润损失、使用损失、直接、间接、附带、后果性或特殊损害的责任，无论是基于合同、侵权、担保或其他原因，无论该方是否事先被告知可能发生此类损害。
Note: The CDISC Intellectual Property Policy can be found at: cdisc_policy_003_intellectual_property_v201408.pdf.