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 |