CDISC的ADaMIG (V1.2) 中英文对照【3】_第三章（下） 标准ADaM变量

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https://www.cdisc.org/standards/foundational/adam/adam-implementation-guide-v1-2-release-package

第3章（下）

（第3章拆分为上下2部分，因字数太多，被限制发表。）

 

3.3.3 Timing Variables for BDS Datasets

Any SDTM timing variables (including, but not limited to, EPOCH, --DTC, --DY, VISITNUM, VISIT, and VISITDY) may be copied into ADaM datasets if they would help to support data traceability and/or show how ADaM timing variables contrast with SDTM data.

Table 3.3.3.1 defines analysis timing variables for BDS datasets. The timing variables whose names start with the letter A are the timing variables directly associated with the AVAL and AVALC variables in the ADaM dataset.

Timing variables not directly characterizing AVAL (e.g., *DT) should be prefixed by a character string instead of the placeholder asterisk shown in Table 3.3.3.3, so that their actual names comply with the variable naming conventions described in Section 3.1, ADaM Variable Conventions. In many cases, the prefix for these date and time variables would match that of an SDTM --DTC, --STDTC or --ENDTC variable name. For example, if a numeric date variable were created from --STDTC, then it would be named --SDT. However, if --DTC or --STDTC is the date that is associated with AVAL and AVALC, its numeric equivalent should be named ADT or ASTDT, as appropriate. The timing variable conventions documented in Section 3.1.2, Timing Variable Conventions, apply here as well.

任何SDTM时序变量（包括但不限于EPOCH，-DTC，-DY，VISITNUM，VISIT和VISITDY）都可以复制到ADaM数据集中，只要它们有助于支持数据可追溯性和/或显示ADaM时序如何变量与SDTM数据形成对比。

表3.3.3.1定义了BDS数据集的分析时间变量。名称以字母A开头的时序变量是与ADaM数据集中的AVAL和AVALC变量直接相关的时序变量。

不能直接表征AVAL的时序变量（例如* DT）应以字符串开头，而不是表3.3.3.3中所示的占位符星号，以使它们的实际名称符合第3.1节“ ADaM变量约定”中描述的变量命名约定。。在许多情况下，这些日期和时间变量的前缀将与SDTM --DTC，-STDTC或--ENDTC变量名的前缀匹配。例如，如果从--STDTC创建了数字日期变量，则它将被命名为--SDT。但是，如果--DTC或--STDTC是与AVAL和AVALC关联的日期，则其数字等效项应适当地命名为ADT或ASTDT。第3.1.2节“时序变量约定”中记录的时序变量约定也适用于此。

 

Table 3.3.3.1 Timing Variables for BDS Datasets

 

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
ADT	Analysis Date	Num		Perm	The date associated with AVAL and/or AVALC in numeric format. 与AVAL和/或AVALC关联的日期，采用数字格式。
ATM	Analysis Time	Num		Perm	The time associated with AVAL and/or AVALC in numeric format. 与AVAL和/或AVALC相关联的时间，采用数字格式。
ADTM	Analysis Datetime	Num		Perm	The datetime associated with AVAL and/or AVALC in numeric format. 与数字格式的AVAL和/或AVALC相关的日期时间。
ADY	Analysis Relative Day	Num		Perm	The relative day of AVAL and/or AVALC. The number of days from an anchor date (not necessarily DM.RFSTDTC) to ADT. See Section 3.1.2, Timing Variable Conventions. AVAL和/或AVALC的相对日期。从锚定日期（不一定是DM.RFSTDTC）到ADT的天数。请参见第3.1.2节，时序变量约定。
ADTF	Analysis Date Imputation Flag	Char	(DATEFL)	Cond	The level of imputation of analysis date. If ADT (or the date part of ADTM) was imputed, ADTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 分析日期的估算水平。如果推定了ADT（或ADTM的日期部分），则必须填充ADTF，并且是必需的。请参见第3.1.3节“日期和时间插补标志变量” 。
ATMF	Analysis Time Imputation Flag	Char	(TIMEFL)	Cond	The level of imputation of analysis time. If ATM (or the time part of ADTM) was imputed, ATMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.   分析时间的估算水平。如果估算出了ATM（或ADTM的时间部分），则必须填充ATMF，并且是必需的。请参见第3.1.3节“日期和时间插补标志变量” 。
Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
ASTDT	Analysis Start Date	Num		Perm	The start date associated with AVAL and/or AVALC. ASTDT and AENDT may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration. 与AVAL和/或AVALC相关的开始日期。当AVAL汇总某个时间间隔内收集的数据时，或者当AVAL是持续时间时，ASTDT和AENDT可能对跟踪很有用。
ASTTM	Analysis Start Time	Num		Perm	The start time associated with AVAL and/or AVALC. ASTTM and AENTM may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration. 与AVAL和/或AVALC相关的开始时间。当AVAL汇总某个时间间隔内收集的数据时，或者当AVAL是持续时间时，ASTTM和AENTM可能对跟踪很有用。
ASTDTM	Analysis Start Datetime	Num		Perm	The start datetime associated with AVAL and/or AVALC. ASTDTM and AENDTM may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration. 与AVAL和/或AVALC相关的开始日期时间。当AVAL汇总一段时间内收集的数据或AVAL是持续时间时，ASTDTM和AENDTM可能对跟踪很有用。
ASTDY	Analysis Start Relative Day	Num		Perm	The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT. See Section 3.1.2, Timing Variable Conventions. 从锚定日期（不一定是DM.RFSTDTC）到ASTDT的天数。请参见第3.1.2节，时序变量约定。
ASTDTF	Analysis Start Date Imputation Flag	Char	(DATEFL)	Cond	The level of imputation of analysis start date. If ASTDT (or the date part of ASTDTM) was imputed, ASTDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.   分析开始日期的估算级别。如果估算了ASTDT（或ASTDTM的日期部分），则必须填充ASTDTF并是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。
ASTTMF	Analysis Start Time Imputation Flag	Char	(TIMEFL)	Cond	The level of imputation of analysis start time. If ASTTM (or the time part of ASTDTM) was imputed, ASTTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 分析开始时间的估算水平。如果推定了ASTTM（或ASTDTM的时间部分），则必须填充ASTTMF，这是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。
AENDT	Analysis End Date	Num		Perm	The end date associated with AVAL and/or AVALC. See also ASTDT. 与AVAL和/或AVALC相关的结束日期。另请参阅ASTDT。
AENTM	Analysis End Time	Num		Perm	The end time associated with AVAL and/or AVALC. See also ASTTM. 与AVAL和/或AVALC相关的结束时间。另请参阅ASTTM。
AENDTM	Analysis End Datetime	Num		Perm	The end datetime associated with AVAL and/or AVALC. See also ASTDTM.   与AVAL和/或AVALC相关的结束日期时间。另请参阅ASTDTM。
AENDY	Analysis End Relative Day	Num		Perm	The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT. See Section 3.1.2, Timing Variable Conventions. 从锚定日期（不一定是DM.RFSTDTC）到AENDT的天数。请参见第3.1.2节，时序变量约定。
AENDTF	Analysis End Date Imputation Flag	Char	(DATEFL)	Cond	The level of imputation of analysis end date. If AENDT (or the date part of AENDTM) was imputed, AENDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 分析结束日期的估算水平。如果推导了AENDT（或AENDTM的日期部分），则必须填充AENDTF，并且是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。
AENTMF	Analysis End Time Imputation Flag	Char	(TIMEFL)	Cond	The level of imputation of analysis end time. If AENTM (or the time part of AENDTM) was imputed, AENTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 分析结束时间的估算水平。如果估算出了AENTM（或AENDTM的时间部分），则必须填充AENTMF，并且是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。
AVISIT	Analysis Visit	Char		Cond	The analysis visit description; required if an analysis is done by nominal, assigned or analysis visit. AVISIT may contain the visit names as observed (i.e., from SDTM VISIT), derived visit names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. AVISIT is a derived field and does not have to map to VISIT from the SDTM. AVISIT represents the analysis visit of the record, but it does not mean that the record was analyzed. There are often multiple records for the same subject and parameter that have the same value of AVISIT. ANLzzFL and other variables may be needed to identify the records selected for any given analysis. See Section 3.3.8, Indicator Variables for BDS Datasets, for information about flag variables. AVISIT should be unique for a given analysis visit window. In the event that a record does not fall within any predefined analysis timepoint window, AVISIT can be populated in any way that the producer chooses to indicate this fact (e.g., blank or "Not Windowed"). The way that AVISIT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for AVISIT. The values and the rules for deriving AVISIT may be different for different parameters within the same dataset. Values of AVISIT are producer-defined, and are often directly usable in Clinical Study Report displays. 分析访问描述；如果通过名义访问，指定访问或分析访问完成了分析，则为必填项。AVISIT可能包含观察到的访问名称（即，来自SDTM VISIT的访问名称），派生的访问名称，时间窗口名称，概念性描述（例如，Average，Endpoint等），或以上任意一项的组合。AVISIT是一个派生字段，不必从SDTM映射到VISIT。AVISIT代表对记录的分析访问，但这并不意味着对记录进行了分析。同一主题通常有多个记录，并且具有相同AVISIT值的参数。可能需要ANLzzFL和其他变量来标识为任何给定分析选择的记录。请参见部分3.3.8，BDS数据集的指标变量，有关标志变量的信息。对于给定的分析访问窗口，AVISIT应该是唯一的。如果记录不在任何预定义的分析时间点窗口之内，则可以使用生产者选择指示该事实的任何方式（例如，空白或“未窗口显示”）填充AVISIT。应在AVISIT的变量元数据中指出AVISIT的计算方式，包括其推导中使用的变量。对于同一数据集中的不同参数，得出AVISIT的值和规则可能会有所不同。AVISIT的值是生产商定义的，通常可以在“临床研究报告”显示中直接使用。
AVISITN	Analysis Visit (N)	Num		Perm	Numeric representation of AVISIT. Since study visits are usually defined by certain timepoints, defining AVISITN so that it represents the timepoint associated with the visit can facilitate plotting and interpretation of the values. Alternatively, AVISITN may be a protocol visit number, a cycle number, an analysis visit number, or any other number logically related to AVISIT or useful for sorting that is needed for analysis. There must be a one-to-one relationship between AVISITN and AVISIT (i.e., AVISITN has the same value for each distinct AVISIT) within a parameter. A best practice is to extend the one-to-one relationship to within a study, but this is not an ADaM requirement. In the event that a record does not fall within any predefined analysis timepoint window, AVISITN can be populated in any way that the producer chooses to indicate this fact (e.g., may be null). Values of AVISITN are producer- defined. AVISITN cannot be present unless AVISIT is also present. On a given record, AVISITN cannot be populated if AVISIT is null. AVISITN can be null when AVISIT is populated, as long as the one-to-one relationship is maintained within a parameter on all rows on which both variables are populated.   AVISIT的数字表示。由于研究访问通常是由某些时间点定义的，因此定义AVISITN使其代表与访问相关的时间点可以方便对值进行绘图和解释。 或者，AVISITN可以是协议访问号，周期号，分析访问号或任何与AVISIT逻辑相关或对分析所需的分类有用的其他号。 参数内的AVISITN和AVISIT之间必须存在一对一的关系（即，AVISITN对于每个不同的AVISIT都具有相同的值）。最佳做法是将一对一关系扩展到研究中，但这不是ADaM的要求。如果记录不在任何预定义的分析时间点窗口之内，则可以用生产者选择指示该事实的任何方式填充AVISITN（例如，可以为null）。AVISITN的值是生产者定义的。 除非还存在AVISIT，否则无法存在AVISITN。在给定的记录上，如果AVISIT为null，则无法填充AVISITN。填充AVISIT时，AVISITN可以为null，只要在填充了两个变量的所有行的参数中都保持一对一关系即可。
ATPT	Analysis Timepoint	Char		Cond	The analysis timepoint description; required if an analysis is done by nominal, assigned or analysis timepoint (instead of or in addition to by-visit). Timepoints are relative to ATPTREF. ATPT may contain the timepoint names as observed (i.e., from SDTM -- TPT), derived timepoint names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. This variable is often used in conjunction with AVISIT. ATPT represents the analysis timepoint of the record. ATPT can be within an analysis visit (e.g., blood pressure assessments at 10 min, 20 min, and 30 min post- dose at AVISIT=Week 1) or can be unrelated to AVISIT (e.g., migraine symptoms 30 min, 60 min, and 120 min post-dose for attack 1). The way that ATPT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for ATPT. The values and the rules for deriving ATPT may be different for different parameters within the same dataset. Values of ATPT are producer-defined, and are often directly usable in Clinical Study Report displays.   分析时间点描述；如果在名义，指定或分析时间点（而不是按次访问）进行分析，则需要进行分析。时间点是相对于ATPTREF的。ATPT可能包含观察到的时间点名称（例如，来自SDTM-TPT），派生的时间点名称，时间窗口名称，概念性描述（例如，Average，Endpoint等），或上述任意一种的组合。此变量通常与AVISIT结合使用。ATPT代表记录的分析时间点。 ATPT可以在分析就诊之内（例如，在AVISIT =第1周时在给药后10分钟，20分钟和30分钟进行血压评估），也可以与AVISIT无关（例如，在30分钟，60分钟和30分钟后出现偏头痛症状）用药后120分钟进行攻击1）。应该在ATPT的变量元数据中指出ATPT的计算方式，包括推导中使用的变量。对于同一数据集中的不同参数，得出ATPT的值和规则可能会有所不同。ATPT的值是生产者定义的，通常可以在“临床研究报告”显示中直接使用。
ATPTN	Analysis Timepoint (N)	Num		Perm	Numeric representation of ATPT. Defining ATPTN so that its values represent the planned timepoints (e.g., minutes or hours after dosing) is not required but can facilitate plotting and interpretation of the values. There must be a one-to-one relationship between ATPTN and ATPT within a parameter. (Best practice would dictate that the mapping would be one-to-one within a study, but that is not an ADaM requirement.) ATPTN cannot be present unless ATPT is also present. When ATPT and ATPTN are present, then on a given record, either both must be populated or both must be null. ATPT的数字表示。无需定义ATPTN，使其值代表计划的时间点（例如，给药后的几分钟或几小时），但是可以帮助绘制和解释该值。参数中的ATPTN和ATPT之间必须存在一对一的关系。（最佳实践表明，映射在研究中是一对一的，但这不是ADaM的要求。） 除非还存在ATPT，否则无法存在ATPTN。如果存在ATPT和ATPTN，则在给定记录上，要么都必须填充要么都必须为空。
ATPTREF	Analysis Timepoint Reference	Char		Perm	Description of the fixed reference point referred to by ATPT/ATPTN (e.g., time of dose). ATPT / ATPTN引用的固定参考点的说明（例如，给药时间）。
APHASE	Phase	Char		Perm	APHASE is a categorization of timing within a study, for example a higher-level categorization of APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON TREATMENT, and FOLLOW-UP. APHASE may be used alone or in addition to APERIOD. APHASE is independent of TRTxxP within ADSL. APHASE may be populated for spans of time where a subject is not on treatment. The value of APHASE (if populated) must be one of the values found in the ADSL APHASEw variables. APHASE是研究中时间的分类，例如APERIOD或分析时期的高级分类。例如，APHASE可以描述筛查，治疗和跟进的时间跨度。APHASE可以单独使用，也可以与APERIOD一起使用。APHASE独立于ADSL中的TRTxxP。在受试者未接受治疗的一段时间内，可能会填充APHASE。APHASE的值（如果已填充）必须是在ADSL APHASEw变量中找到的值之一。
APHASEN	Phase (N)	Num		Perm	Numeric representation of APHASE. The value of APHASEN (if populated) must be one of the w values found in the ADSL APHASEw variable names. There must be a one-to-one relationship between APHASEN and APHASE within a study, which must be the same as the one-to-one mapping between w and APHASEw in ADSL. APHASEN cannot be present unless APHASE is also present. When APHASE and APHASEN are present, then on a given record, either both must be populated or both must be null.   APHASE的数字表示。APHASEN的值（如果已填充）必须是在ADSL APHASEw变量名称中找到的w值之一。一项研究中，APHASEN和APHASE之间必须存在一对一的关系，该关系必须与ADSL中w和APHASEw之间的一对一映射相同。 除非还存在APHASE，否则无法存在APHASEN。当存在APHASE和APHASEN时，则在给定记录上，要么都必须填充要么都必须为空。
APERIOD	Period	Num		Cond	APERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variable names. APERIOD is required if ASPER is present. APERIOD must be populated on all records where ASPER is populated.   APERIOD是记录级别的时序变量，代表与分析相关的记录相关的研究中的分析时间段。APERIOD的值（如果已填充）必须是在ADSL TRTxxP变量名称中找到的xx值之一。如果存在ASPER，则需要APERIOD。必须在填充ASPER的所有记录上填充APERIOD。
APERIODC	Period (C)	Char		Perm	Text characterizing to which analysis period the record belongs. There must be a one-to-one relationship between APERIODC and APERIOD within a study. APERIODC cannot be present unless APERIOD is also present. When APERIOD and APERIODC are present, then on a given record, either both must be populated or both must be null.   描述记录所属分析期间的文本。研究中APERIODC与APERIOD之间必须存在一对一的关系。除非还存在APERIOD，否则无法存在APERIODC。如果存在APERIOD和APERIODC，则在给定记录上，要么都必须填充，要么都必须为null。
ASPER	Subperiod within Period	Num		Perm	The numeric value characterizing a sublevel within APERIOD to which the record belongs. Within each APERIOD, the first ASPER is 1 (i.e., it resets to 1 when the APERIOD value changes). The value of ASPER (if populated) must be one of the w values found in the ADSL PxxSw variable names. 表示记录所属的APERIOD中子级别的数字值。在每个APERIOD中，第一个ASPER为1（即，当APERIOD值更改时，它会重置为1）。ASPER的值（如果已填充）必须是ADSL PxxSw变量名称中的w值之一。
ASPERC	Subperiod within Period (C)	Char		Perm	Text characterizing to which subperiod the record belongs. There must be a one-to-one relationship between ASPERC and ASPER within a value of APERIOD, which must be the same as the one-to-one mapping between PxxSw and w in ADSL, where xx is equal to the value of APERIOD. The value of ASPERC (if populated) must be one of the values found in the ADSL PxxSw variables. ASPERC cannot be present unless ASPER is also present. When ASPER and ASPERC are present, then on a given record, either both must be populated or both must be null.   描述记录所属子时段的文本。在APERIOD值之内，ASPERC和ASPER之间必须存在一对一的关系，该关系必须与ADSL中PxxSw和w之间的一对一映射相同，其中xx等于APERIOD的值。ASPERC的值（如果已填充）必须是ADSL PxxSw变量中的值之一。 除非也存在ASPER，否则不能存在ASPERC。如果存在ASPER和ASPERC，则在给定记录上，要么都必须填充要么都必须为null。
ARELTM	Analysis Relative Time	Num		Perm	The time relative to an anchor time. The amount of time from an anchor time to ATM. When ARELTM is present, the anchor time variable and ARELTMU must also be included in the dataset, and the anchor time variable must be identified in the metadata for ARELTM. 相对于锚点时间的时间。从定位时间到ATM的时间。如果存在ARELTM，则锚定时间变量和ARELTMU也必须包含在数据集中，并且锚定时间变量必须在ARELTM的元数据中标识。
ARELTMU	Analysis Relative Time Unit	Char		Perm	The units of ARELTM. For example, "HOURS" or "MINUTES." ARELTMU is required if ARELTM is present. ARELTM的单位。例如，“小时”或“分钟”。如果存在ARELTM，则需要ARELTMU。

Additional timing variables can be included for phase, period, and subperiod. The values of period, subperiod, and phase start (and end) timing variables must be consistent with their subject-level counterparts from ADSL as described in Table 3.2.7 for each value of APERIOD, ASPER, and APHASE, respectively. Table 3.3.3.2 provides the record-level variables for these timing elements.

可以在阶段，周期和子周期中包含其他时序变量。周期，子周期和相位开始（和结束）定时变量的值必须与表3.2.7 中分别针对APERIOD，ASPER和APHASE的值所描述的ADSL的主题级对应变量一致。表3.3.3.2提供了这些计时元素的记录级变量。

 

Table 3.3.3.2 Period, Subperiod, and Phase Start and End Timing Variables

表3.3.3.2周期，子周期以及相位开始和结束时间变量

 

 

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
APERSDT	Period Start Date	Num		Perm	The starting date for the period defined by APERIOD. APERIOD定义的期间的开始日期。
APERSTM	Period Start Time	Num		Perm	The starting time for the period defined by APERIOD. APERIOD定义的时间段的开始时间。
APERSDTM	Period Start Datetime	Num		Perm	The starting datetime for the period defined by APERIOD. APERIOD定义的期间的开始日期时间。
APERSDTF	Period Start Date Imput. Flag	Char	(DATEFL)	Cond	The level of imputation of period start date. If APERSDT (or the date part of APERSDTM) was imputed, APERSDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 期间开始日期的估算级别。如果推定了APERSDT（或APERSDTM的日期部分），则必须填充APERSDTF，并且是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。 期间开始日期的估算级别。如果推定了APERSDT（或APERSDTM的日期部分），则必须填充APERSDTF，并且是必需的。请参见第3.1.3节“ 日期和时间插补标志变量” 。
APERSTMF	Period Start Time Imput. Flag	Char	(TIMEFL)	Cond	The level of imputation of period start time. If APERSTM (or the time part of APERSDTM) was imputed, APERSTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables. 期间开始时间的估算级别。如果APERSTM（或APERSDTM的时间部分）为根据估算，必须填充APERSTMF，并且是必需的。请参见第3.1.3节“日期和时间插补标志变量” 。
APEREDT	Period End Date	Num		Perm	The ending date for the period defined by APERIOD. APERIOD定义的期间的结束日期。
APERETM	Period End Time	Num		Perm	The ending time for the period defined by APERIOD. APERIOD定义的期间的结束时间。
APEREDTM	Period End Datetime	Num