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

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第3章（上）

（第3章拆分为上下2部分，因字数太多，被限制发表。）

3 Standard ADaM Variables 标准ADaM变量

Section 3, Standard ADaM Variables, defines the required characteristics of standard variables (columns) that are frequently needed in ADaM datasets. The ADaM standard requires that these variable names be used when a variable that contains the content defined in Section 3 is included in any ADaM dataset, regardless of dataset class. It also requires these ADaM standard variables be used for the purposes indicated, even if the content of an ADaM variable is a copy of the content of an SDTM dataset variable.

第3节“标准ADaM变量”定义了标准变量（列）的必需特征，这些特征是在ADaM数据集中经常需要。 ADaM标准要求在以下情况下使用这些变量名：包含第3节中定义的内容的变量包含在任何ADaM数据集中，无论该数据集如何类。 它还要求将这些ADaM标准变量用于指定的目的，即使ADaM变量是SDTM数据集变量内容的副本。

Section 3 also defines standard naming fragments (with position within the variable name included as the part of the definition in some instances) to be used in creating new variable names. In the variable name fragments presented later in this section, an asterisk (*) is used to indicate that one or more letters can be added to create a producer-specific variable name. If a fragment is defined for a specific concept (see Section 3.1.5, Variable Naming Fragments), it is best practice that any variable related to the concept contain the defined fragment in its name. Specific fragments, described in Table 3.1.5.1, are required to be used whenever the concept applies and are reserved to be used only for the corresponding concept. For example, the fragment "DTF" is defined as a suffix for date imputation flag variables; therefore, a variable that indicates the level of imputation must contain "DTF" as the last three characters in the variable name. In addition, Table 3.1.5.2 and Table 3.3.3.3 list fragments that can be used when naming variables in ADaM datasets. These lists of fragments are provided as a guide when naming variables in ADaM datasets. In addition, fragments defined in the SDTM and SDTMIG must be considered in order to avoid creating an ADaM variable with the same name as an SDTM dataset variable.

第3节还定义了标准命名片段（在某些情况下，其名称中的位置作为定义的一部分包含在变量名中）将用于创建新的变量名。在本节后面提供的变量名片段中，星号（*）表示可以添加一个或多个字母来创建特定于生产者？（producer）的变量名。如果为特定概念定义了一个片段（请参见第3.1.5节，变量命名片段），则最佳实践是与该概念相关的任何变量都在其名称中包含已定义的片段。每当应用该概念时，都必须使用表3.1.5.1中描述的特定片段，并保留这些片段仅用于相应的概念。例如，片段“ DTF”被定义为日期插补标志变量的后缀；因此，指示插补级别的变量必须在变量名的最后三个字符中包含“ DTF”。此外，表3.1.5.2和表3.3.3.3列出了在ADaM数据集中命名变量时可以使用的片段。这些片段列表作为在ADaM数据集中命名变量的指南。此外，必须考虑在SDTM和SDTMIG中定义的片段，以避免创建与SDTM数据集变量同名的ADaM变量。

Section 3.1, ADaM Variable Conventions, defines ADaM variable conventions that apply to all ADaM variables, including the standard ADaM variables specified in Sections 3.2, ADSL Variables, and 3.3, ADaM Basic Data Structure (BDS) Variables, as well as producer-defined ADaM variables. Section 3.2, ADSL Variables, describes variables in ADSL. Section 3.3, ADaM Basic Data Structure (BDS) Variables, describes variables in the BDS. Section 3.4, Analysis-Enabling Variables, describes variables that are not specific to ADSL or BDS structures.

第3.1节“ ADaM变量约定”定义了适用于所有ADaM变量的ADaM变量约定，包括第3.2节ADSL变量和3.3，ADaM基本数据结构（BDS）变量以及生产者定义的ADaM中指定的标准ADaM变量。第3.2节“ ADSL变量”介绍了ADSL中的变量。 第3.3节ADaM基本数据结构（BDS）变量描述了BDS中的变量。 第3.4节“启用分析的变量”介绍了并非特定于ADSL或BDS结构的变量。

In Section 3, ADaM variables are described in tabular format. The two rightmost columns, "Core" and "CDISC Notes", provide information about the variables to assist producers in preparing their datasets. These columns are not meant to be metadata submitted in define.xml. The "Core" column describes whether a variable is required, conditionally required, or permissible. The "CDISC Notes" column provides more information about the variable. In addition, the "Type" column specifies whether the variable being described is character or numeric. A richer set of data types (e.g., text, integer, float), described in the Define-XML Specification (available at https://www.cdisc.org/standards/data-exchange/define-xml), should be provided in the metadata by the producer.

在第3节中，以表格格式描述ADaM变量。 最右边的两列“Core”和“ CDISC Notes”提供了有关变量的信息，以帮助生产者准备其数据集。 这些列并不意味着是在define.xml中提交的元数据。 “核心”列描述了变量是必需变量，有条件必需变量还是允许变量。 “ CDISC注意事项”列提供有关该变量的更多信息。 此外，“类型”（Type）列指定所描述的变量是字符还是数字。 应该在生产者的元数据中提供一组在Define-XML规范（在https://www.cdisc.org/standards/data-exchange/define-xml中提供）中描述的更丰富的数据类型（例如，文本，整数，浮点数。）。

Values of ADaM "Core" Attribute

Req = Required. The variable must be included in the dataset.

Cond = Conditionally required. The variable must be included in the dataset in certain circumstances.

Perm = Permissible. The variable may be included in the dataset, but is not required.

Unless otherwise specified, all ADaM variables are populated as appropriate, meaning nulls are allowed.

ADaM “Core”属性的值

Req =必填。 该变量必须包含在数据集中。

Cond =有条件的必需。 在某些情况下，变量必须包含在数据集中。

Perm =允许。 该变量可以包含在数据集中，但不是必需的。除非另有说明，否则将适当地填充所有ADaM变量，这意味着允许为空。

3.1 ADaM Variable Conventions

3.1.1 General Variable Conventions

1. To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be composed only of letters (A-Z), underscore ( _ ), and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All ADaM character variables must be no more than 200 characters in length.

1.为确保符合SAS版本5传输文件格式和Oracle约束，所有ADaM变量名称的长度必须不超过8个字符，以字母开头（不带下划线），并且仅由字母（AZ），下划线组成 （_）和数字（0-9）。 所有ADaM变量标签的长度不得超过40个字符。 所有ADaM字符变量的长度都不得超过200个字符。

1. 1. The lower-case letters "w", "xx", "y", and "zz" that appear in a variable name or label in this document must be replaced in the actual variable name or label using the following conventions: a. The lower-case letter "w" in a variable name (e.g., PHwSDT, PxxSwSDT) is an index for the wth variable where "w" is replaced with a single digit [1–9].
   2. 本文档中变量名称或标签中出现的小写字母“ w”，“ xx”，“ y”和“ zz”必须使用以下约定替换为实际的变量名称或标签：

1. 1. 变量名称（例如PHwSDT，PxxSwSDT）中的小写字母“ w”是wth变量的索引，其中“ w”用一位数字[1–9]代替。

1. 1. The letters "xx" in a variable name (e.g., TRTxxP, APxxSDT) refer to a specific period where "xx" is replaced with a zero-padded two-digit integer [01–99]. The use of "xx" within a variable name is restricted to the concept of a period, and "xx" is not considered an index.
   2. 变量名称中的字母“ xx”（例如TRTxxP，APxxSDT）指的是特定时间段，其中“ xx”被填充了零的两位整数[01-99]代替。 在变量名中使用“ xx”仅限于句点，“ xx”不被视为索引。
   3. The lower-case letter "y" in a variable name (e.g., SITEGRy) refers to a grouping or other categorization scheme, an analysis criterion, or an analysis range, and is replaced with an integer [1–99, not zero-padded]. Truncation of the original variable name may be necessary in rare situations when a two-digit index is needed and causes the length of the variable name to exceed 8 characters. In these situations, it is recommended that the same truncation be used for both the character and numeric versions of the variables in a variable pair.

c.变量名（例如，SITEGRy）中的小写字母“ y”是指分组或其他分类方案，分析标准或分析范围，并被整数[1–99，不填充零 ]。 在极少数情况下，当需要两位数字索引并且导致变量名的长度超过8个字符时，可能需要截断原始变量名。 在这些情况下，建议对变量对中的变量的字符和数字版本都使用相同的截断。

1. 1. The lower-case letters "zz" in a variable name (e.g., ANLzzFL) are an index for the zzth variable where "zz" is replaced with a zero-padded two-digit integer [01-99]. Note that the "zz" convention represents a simple counter, while the "xx" convention represents a specific perio
   2. 变量名称（例如ANLzzFL）中的小写字母“ zz”是zzth变量的索引，其中“ zz”被填充了零的两位整数[01-99]取代。 请注意，“ zz”约定代表一个简单的计数器，而“ xx”约定代表一个特定的时期。
   3. If an indexed variable is included in a dataset, there is no requirement that the preceding variable(s) in the sequence be included. For example, a dataset might include ANL02FL but not ANL01FL.
   4. 如果数据集中包含有索引变量，则无需包含序列中的先前变量。 例如，数据集可能包括ANL02FL，但不包括ANL01FL。

3. Any variable in an ADaM dataset whose name is the same as an SDTM variable must be a copy of the SDTM variable, and its label, meaning, and values must not be modified. ADaM adheres to a principle of harmonization known as "same name, same meaning, same values." However, to optimize file size, it is permissible that the length of the variables differ (e.g., trailing blanks may be removed). In many cases it makes sense to copy over a variable from an SDTM dataset. For example, the SDTM variable --SEQ may be useful for traceability. However, in other cases, it is also perfectly acceptable, and might be much better, to create an ADaM variable with a meaningful variable name and clear and unambiguous metadata. An SDTM variable may be somewhat meaningless when removed from its SDTM context. For example, the meaning of the SDTM variable DSDECOD may depend on other SDTM variables such as DSCAT and DSSCAT, and ultimately on how the data were collected and mapped to SDTM in a particular study; thus it may be better to create a clearly defined ADaM variable. In any case, whenever values are modified in any way, it is mandatory to do so in an ADaM variable, and it is prohibited to do so in a variable whose name is that of an SDTM variable.

3.ADaM数据集中名称与SDTM变量相同的任何变量都必须是SDTM变量的副本，并且其标签，含义和值均不得修改。 ADaM坚持被称为“相同名称(same name)，相同含义(same meaning)，相同值(same values)”的协调原则。但是，为了优化文件大小，允许变量的长度不同（例如，可以删除尾随空白）。在许多情况下，从SDTM数据集中复制变量是有意义的。例如，SDTM变量--SEQ可用于可追溯性。但是，在其他情况下，创建具有有意义的变量名称和清晰且明确的元数据的ADaM变量也是完全可以接受的，并且可能会更好。将SDTM变量从其SDTM上下文中删除时，可能在某种程度上没有意义。例如，SDTM变量DSDECOD的含义可能取决于其他SDTM变量（例如DSCAT和DSSCAT），最终取决于在特定研究中如何收集数据并将其映射到SDTM；因此，最好创建一个明确定义的ADaM变量。无论如何，无论何时以任何方式修改值，都必须在ADaM变量中进行修改，并且禁止在名称为SDTM变量的变量中进行修改。

4. When an ADaM standard variable name has been defined for a specific concept, the ADaM standard variable name must be used, even if the content of an ADaM variable is a direct copy of the content of an SDTM variable. For example, in the creation of an ADaM dataset based on an SDTM LB dataset, even if AVAL is just a copy of LBSTRESN, the dataset must contain AVAL.

4.在为特定概念定义了ADaM标准变量名称后，即使ADaM变量的内容是SDTM变量内容的直接副本，也必须使用ADaM标准变量名称。 例如，在基于SDTM LB数据集创建ADaM数据集时，即使AVAL只是LBSTRESN的副本，该数据集也必须包含AVAL。

5. For variable pairs designated as having a one-to-one relationship within a specified scope (e.g., within a parameter, within a study), if both variables are present in the dataset and there exists a row in that scope on which both variables are populated, then there must be a one-to-one relationship between the two variables on all rows within the scope on which both variables are populated. The scope noted in this document should be considered the minimum level for the mapping; it does not preclude the producer from using a broader level of scope. For example, if a one-to-one relationship is specified as within a PARAM, the producer may elect to use the same one-to-one relationship across all PARAMs within the dataset or study. In addition, note that "within a parameter" means "within a parameter within a dataset."

5.对于指定为在指定范围内（例如，在参数内，研究内）具有一对一关系的变量对，如果两个变量都存在于数据集中，并且在该范围内存在一行 变量被填充，那么在填充两个变量的范围内的所有行上的两个变量之间必须存在一对一的关系。 本文档中指出的范围应视为映射的最低级别； 它并不排除生产者使用更大范围的范围。 例如，如果在PARAM中指定了一对一关系，则生产者可以选择在数据集或研究中的所有PARAM中使用相同的一对一关系。 另外，请注意，“参数内”是指“数据集中的参数内”。

6. In a pair of corresponding variables (e.g., TRTP and TRTPN), the primary or most commonly used variable does not have the suffix or extension (i.e., N for numeric or C for character). The relevant suffix is used only on the name of the secondary member of the variable pair. For example, in the (TRTP, TRTPN) pair, the primary variable, TRTP, is character, but it is not named TRTPC. Similarly in the (APERIOD, APERIODC) pair, the primary variable, APERIOD, is numeric, but it is not named APERIODN. When a secondary variable is included in the dataset, then the primary variable must also be included. . If both variables of a variable pair are present, there must be a one-to-one relationship between the values of the two variables, as described in Item 5 above.

6.在一对相应的变量（例如TRTP和TRTPN）中，主要或最常用的变量没有后缀或扩展名（即N代表数字或C代表字符）。 相关后缀仅在变量对的次要成员的名称上使用。 例如，在（TRTP，TRTPN）对中，主变量TRTP是字符，但未命名为TRTPC。 类似地，在（APERIOD，APERIODC）对中，主变量APERIOD是数字的，但未命名为APERIODN。 当数据集中包含次级变量时，则还必须包含初级变量。如果存在变量对的两个变量，则两个变量的值之间必须存在一对一的关系，如上面第5项所述。

7. In general, if an SDTM character variable is converted to a numeric variable in an ADaM dataset, then it should be named as it is in the SDTM dataset with an "N" suffix added. For example, the numeric version of the DM variable SEX is SEXN in an ADaM dataset, and a numeric version of RACE is RACEN. As stated in item 6, the secondary variable of the variable pair cannot be present in the dataset unless the primary variable is also present. Applying Item 6 to the variable pairs being described in Item 7, the numeric equivalent of the variable cannot be present in the dataset unless the character version is also present. If necessary to keep within the eight-character variable name length limit, the last character may be removed prior to appending the N. Note that this naming scheme applies only to numeric variables whose values have a one-to-one relationship to the values of the equivalent character variables. Note also that this convention does not apply to SDTM date/time ISO8601-formatted character variables converted to ADaM numeric *DT, *TM, and *DTM variables.

7.通常，如果将SDTM字符变量转换为ADaM数据集中的数字变量，则应在SDTM数据集中按原样命名，并添加“ N”后缀。例如，DM变量SEX的数字版本在ADaM数据集中为SEXN，而RACE的数字版本为RACEN。如第6项所述，变量对的次级变量不能存在于数据集中，除非还存在初级变量。将第6项应用于第7项中描述的变量对，变量的数值等效项就不能出现在数据集中，除非还存在字符版本。如果有必要保持在八个字符的变量名长度限制内，可以在附加N之前删除最后一个字符。请注意，此命名方案仅适用于其值与的值具有一对一关系的数字变量。等效字符变量。还请注意，此约定不适用于转换为ADaM数字* DT，* TM和* DTM变量的SDTM日期/时间ISO8601格式的字符变量。

8. Variables whose names end in FL are character flag (or indicator) variables with at most two possible non-missing values, Y or N (i.e., yes or no). The name of the corresponding numeric flag (or indicator) variable ends in FN. If the flag is included in an ADaM dataset, the character version (*FL) is required but the corresponding numeric version (*FN) can also be included. If both versions of the flag are included, there must be a one-to-one relationship between the values of the two variables, as described in Section 3.1.4, Flag Variable Conventions.

8.名称以FL结尾的变量是字符标记（或指示符）变量，最多包含两个可能的非缺失值Y或N（即，是或否）。 相应的数字标志（或指示符）变量的名称以FN结尾。 如果标志包含在ADaM数据集中，则需要字符版本（* FL），但也可以包括相应的数字版本（* FN）。 如果同时包含标志的两个版本，则两个变量的值之间必须存在一对一的关系，如第3.1.4节“标志变量约定”中所述。

9. Variables whose names end in GRy, Gy, or CATy are grouping variables, where "y" refers to the grouping scheme or algorithm (not the category within the grouping). For example, SITEGR3 is the name of a variable containing site group (pooled site) names, where the grouping has been done according to the third site-grouping algorithm; SITEGR3 does not mean the third group of sites. Within this document, CATy is the suffix used for categorization of ADaM-specified analysis variables (e.g., CHGCATy categorizes CHG).

9.名称以GRy，Gy或CATy结尾的变量是分组变量，其中“ y”是指分组方案或算法（不是分组内的类别）。 例如，SITEGR3是包含站点组（合并站点）名称的变量的名称，其中已根据第三种站点分组算法进行了分组； SITEGR3并不意味着第三组站点。 在本文档中，CATy是用于对ADaM指定的分析变量进行分类的后缀（例如，CHGCATy对CHG进行分类）。

10. It is recommended that producer-defined grouping or categorization variables begin with the name of the variable being grouped and end in GRy (e.g., variable ABCGRy is a character description of a grouping or categorization of the values from the ABC variable for analysis purposes). If any grouping of values from an SDTM variable is done, the name of the derived ADaM character grouping variable should begin with the SDTM variable name and end in GRy (GRyN for the numeric equivalent) where y is an integer [1-99, not zero-padded] representing a grouping scheme. For example, if a character analysis variable is created to contain values of Caucasian and Non-Caucasian from the SDTM RACE variable, then it should be named RACEGRy and its numeric equivalent should be named RACEGRyN (e.g., RACEGR1, RACEGR1N). As described in Table 3.1.5.1, Gy can be used as an abbreviated form of GRy when the use of GRy would create a variable name longer than 8 characters. Truncation of the original variable name may be necessary when appending suffix fragments GRy, GRyN, Gy, or GyN.

10.建议生产者定义的分组或分类变量以要分组的变量的名称开头，并以GRy结尾（例如，变量ABCGRy是对ABC变量的值进行分组或分类的字符描述，以用于分析目的）。如果对SDTM变量的值进行了任何分组，则派生的ADaM字符分组变量的名称应以SDTM变量名称开头，并以GRy（等效于GRyN）结束，其中y是整数[1-99，而不是零填充]代表分组方案。例如，如果创建了一个字符分析变量以包含SDTM RACE变量中的高加索和非高加索值，则应将其命名为RACEGRy，并将其数值等效项命名为RACEGRyN（例如RACEGR1，RACEGR1N）。如表3.1.5.1中所述，当使用GRy会创建长度超过8个字符的变量名时，Gy可以用作GRy的缩写形式。当附加后缀片段GRy，GRyN，Gy或GyN时，可能有必要截断原始变量名。

3.1.2 Timing Variable Conventions

1. Numeric date, time, and datetime variables should be formatted, so as to be human-readable with no loss of precision.

1.应该对数字日期，时间和日期时间变量进行格式化，以使其易于阅读且不失精度。

2. Variables whose names end in DT are numeric dates.

2.名称以DT结尾的变量是数字日期。

3. Variables whose names end in DTM are numeric datetimes.

3.名称以DTM结尾的变量是数字日期时间。

4. Variables whose names end in TM are numeric times.

4.名称以TM结尾的变量是数字时间。

5. If a *DTM and associated *TM variable exist, then the *TM value must match the time part of the *DTM value when the *DTM variable is populated. If a *DTM and associated *DT variable exist, then the *DT value must match the date part of the *DTM value when the *DTM variable is populated.

5.如果存在* DTM和关联的* TM变量，则在填充* DTM变量时，* TM值必须与* DTM值的时间部分匹配。 如果存在* DTM和关联的* DT变量，那么在填充* DTM变量时，* DT值必须与* DTM值的日期部分匹配。

6. Names of timing start variables end with an S followed by the characters indicating the type of timing (i.e., SDT, STM, SDTM), unless otherwise specified elsewhere in Section 3, Standard ADaM Variables.

6.时间开始变量的名称以S结尾，后跟指示定时类型的字符（即SDT，STM，SDTM），除非在第3节“标准ADaM变量”中另有说明。

7. Names of timing end variables end with an E followed by the characters indicating the type of timing (i.e., EDT, ETM, EDTM), unless otherwise specified elsewhere in Section 3, Standard ADaM Variables.

7.时间结束变量的名称以E结尾，后跟指示定时类型的字符（即EDT，ETM，EDTM），除非在第3部分“标准ADaM变量”中另有说明。

8. Variables whose names end in DY are relative day variables. In the ADaM as in the SDTM, there is no Day 0. If there is a need to create a relative day variable that includes Day 0, then its name must not end in DY.

8.名称以DY结尾的变量是相对日期变量。 与SDTM中一样，在ADaM中没有Day0。如果需要创建一个包括Day 0的相对day变量，则其名称不得以DY结尾。

9. ADaM relative day variables need not be anchored by DM.RFSTDTC. The anchor (i.e., reference) date variable must be indicated in the variable-level metadata for the relative day variable. The anchor date variable should also be included in ADSL or the current ADaM dataset to facilitate traceability. Similarly, anchor time variables used to calculate values for ADaM relative time variables must be indicated in the variable-level metadata for the relative time variable, and must be included in ADSL or the current ADaM dataset. Note that it is possible to have different definitions for a relative day (or time) variable (e.g., ADY) in separate datasets, using different anchor dates (or times). For example, the derivation of ADY for efficacy datasets might be different from that for safety datasets.

9. ADaM相对日变量不必由DM.RFSTDTC锚定。 必须在相对日期变量的变量级元数据中指定锚定（即参考）日期变量。 锚定日期变量也应包含在ADSL或当前的ADaM数据集中，以促进可追溯性。 同样，用于计算ADaM相对时间变量值的锚定时间变量必须在相对时间变量的变量级别元数据中指出，并且必须包含在ADSL或当前ADaM数据集中。 请注意，可以使用不同的定位日期（或时间）在单独的数据集中为相对日期（或时间）变量（例如ADY）设置不同的定义。 例如，功效数据集的ADY推导可能与安全性数据集的推导不同。

10. Table 3.3.3.3 presents standard suffix naming conventions for producer-defined supportive variables containing numeric dates, times, datetimes, and relative days, as well as date and time imputation flags. These conventions are applicable to all ADaM datasets. The asterisk that appears in a variable name in the table must be replaced by a suitable character string, so that the actual variable name is meaningful and complies with the restrictions noted in Section 3.1.1, General Variable Conventions.

10.表3.3.3.3列出了生产商定义的支持变量的标准后缀命名约定，其中包含数字日期，时间，日期时间和相对天数以及日期和时间插补标志。 这些约定适用于所有ADaM数据集。 表中变量名中出现的星号必须替换为合适的字符串，这样实际的变量名才有意义，并符合第3.1.1节“通用变量约定”中所述的限制。

1. 1. The reader is cautioned that the root or prefix (represented by *) of such producer-specified supportive ADaM date, time and datetime variable names must be chosen with care, to prevent unintended conflicts among other such names and standard numeric versions of possible SDTM variable names. In particular, potentially problematic values for producer-defined roots/prefixes (*) include: a. One-letter prefixes. For an example of the problem, if * is Q, then a date *DT would be QDT; however, a starting date *SDT would be QSDT, which would potentially be confusing if the producer intended QSDT to be something other than the numeric date version of the SDTM variable QSDTC.
   2. 请读者注意，必须谨慎选择此类生产者指定的支持性ADaM日期，时间和日期时间变量名称的根或前缀（用*表示），以防止其他此类名称与可能的标准数字版本之间发生意外冲突 SDTM变量名称。 特别是，生产者定义的根/前缀（*）可能存在问题的值包括：

1. 1. 单个字母前缀。 例如，如果*为Q，则日期* DT为QDT； 但是，开始日期* SDT将是QSDT，如果生产者希望QSDT不是SDTM变量QSDTC的数字日期版本，则可能会造成混淆。
   2. Two-letter prefixes, except when intentionally chosen to refer explicitly to a specific SDTM domain and its --DTC, --STDTC, and/or --ENDTC variables. For an example of an appropriate intentional use of a two-letter prefix, if * is LB, then *DT is LBDT, the numeric date version of SDTM variable LBDTC. For an example of the problem, if * is QQ, then a date *DT would be QQDT, which would potentially be confusing if the producer intended QQDT to be something other than the numeric date version of a potential SDTM variable QQDTC.
   3. 两个字母的前缀，除非有意选择明确引用特定的SDTM域及其--DTC，--STDTC和/或--ENDTC变量。 对于适当使用两个字母前缀的示例，如果*为LB，则* DT为LBDT，即SDTM变量LBDTC的数字日期版本。 对于问题的一个示例，如果*是QQ，则日期* DT将是QQDT，如果生产者将QQDT设置为潜在SDTM变量QQDTC的数字日期版本以外的其他名称，则可能会造成混淆。
   4. Three-letter prefixes ending in S or E. For an example of the problem, if * is QQS, then a date *DT would be QQSDT, which would potentially be confusing if the producer intended QQSDT to be something other than the numeric date version of a potential SDTM variable QQSTDTC.
   5. 三个字母的前缀以S或E结尾。例如，如果*是QQS，则日期* DT将是QQSDT，如果生产者打算将QQSDT设置为数字日期版本以外的其他名称，则可能会造成混淆。 SDTM变量QQSTDTC的值。

1. 1. In general, all three of *DT, *TM, *DTM are not required. Include only the *DT, *TM, and *DTM variables needed for analysis or review. However, when a *DTM variable exists, it is good practice to include a corresponding *DT variable.
   2. 通常，不需要* DT，* TM，* DTM的全部三个。 仅包括分析或查看所需的* DT，* TM和* DTM变量。 但是，当存在* DTM变量时，优良作法是包括相应的* DT变量。

1. 1. more information regarding date and time variable conventions, refer to Table 3.3.3.3.

• • 3.3.3.3。

3.1.3 Date and Time Imputation Flag Variables

3.1.3日期和时间Imputation标记变量

When a date or time is imputed, it is required that the variable containing the imputed value be accompanied by a date or time imputation flag variable. The variable fragments to be used for these variables are DTF and TMF, as defined in Table 3.1.5.1. DF and TF can be used as abbreviated forms of DTF and TMF, respectively, when the use of DTF or TMF would create a variable name longer than 8 characters. These additional imputation flag variables are conditionally required. The root, identified by "*", of the names of each pair of variables, *DT and *DTF (or *DF), should be identical. The same is true for the corresponding time and imputation flag variables *TM and *TMF (or *TF). Thus it is good practice to limit roots to 5 characters in length.

插补日期或时间时，要求包含插补值的变量带有日期或时间插补标志变量。 如表3.1.5.1所定义，用于这些变量的变量片段是DTF和TMF。 当使用DTF或TMF会创建一个长度超过8个字符的变量名时，DF和TF可以分别用作DTF和TMF的缩写形式。 这些附加的插补标志变量是有条件的。 每对变量* DT和* DTF（或* DF）的名称的由“ *”标识的根应该相同。 相应的时间和插补标志变量* TM和* TMF（或* TF）也是如此。 因此，最好将根的长度限制为5个字符。

Section 3 contains sets of timing variables which share a common prefix, such as TRTSDT, TRTSTM, and TRTSDTM. It should be noted that in many instances in Section 3, specific DTF and TMF flags are defined within sets of timing variables. However, imputation flags should be created for all date or time variables when imputation has been performed, even if there is not a specific imputation flag variable mentioned in Section 3. For example, the imputation flag variable has not been listed for EOSDT, but EOSDTF must be present if date imputation was performed.

第3节包含共享共同前缀的时间变量集，例如TRTSDT，TRTSTM和TRTSDTM。 应该注意的是，在第3节的许多情况下，特定的DTF和TMF标志是在时序变量集合中定义的。 但是，即使已经在第3节中提到了特定的插补标记变量，执行插补后，也应该为所有日期或时间变量创建插补标记。例如，EOSDT中未列出插补标记变量，但是EOSDTF 如果执行了日期估算，则必须存在。

1. As described in Table 3.1.5.1, variables whose names end in DTF are date imputation flags. *DTF variables represent the highest level of imputation of the *DT variable based on the source SDTM dataset DTC variable. *DTF = Y if the year is imputed. *DTF = M if year is present and month is imputed. *DTF = D if only day is imputed. *DTF = null if *DT equals the SDTM dataset DTC variable date part equivalent. If a date was imputed, *DTF must be populated and is required. Both *DTF and *TMF may be needed to describe the level of imputation in *DTM if imputation was done. Note that the list of examples in Table 3.1.3.1 is not exhaustive.

1.如表3.1.5.1中所述，名称以DTF结尾的变量是日期插补标志。 * DTF变量表示基于源SDTM数据集DTC变量的* DT变量的最高估算级别。 * DTF = Y（如果推算年份）。 * DTF = M（如果存在年份并且推算月份）。 * DTF = D（如果仅推算一天）。 如果* DT等于SDTM数据集DTC可变日期部分的等效值，则* DTF = null。 如果估算了日期，则必须填写* DTF并为必填项。 如果进行了插补，则可能需要* DTF和* TMF来描述* DTM中的插补级别。 请注意，表3.1.3.1中的示例列表并不详尽。

Missing Elements	SDTM --DTC String	ADaM Date Value (*DT Variable)[1,2] (## indicates imputed portion)	Imputation flag (*DTF variable)
None	YYYY-MM-DD	YYYY-MM-DD	Blank
Day	YYYY-MM	YYYY-MM-##	D
Month	YYYY---DD	YYYY-##-DD	M
Month and Day	YYYY	YYYY-##-##	M
Year	--MM-DD	####-MM-DD	Y
Year and Month	---DD	####-##-DD	Y
Year and Month and Day		########	Y
[1] The ISO formats used in the ADaM Date Value column are for the purposes of illustration, and are not intended to imply any type of display standard or requirement. The DT variable is numeric and the producer will determine the appropriate display format. [1]  ADaM日期值列中使用的ISO格式仅用于说明目的，并不表示任何类型的显示标准或要求。 DT变量是数字，生产者将确定适当的显示格式。 [2] The indication of imputed values is not intended to imply an imputation rule or standard. For example, if the month is missing, imputation rules might specify that the collected day value be ignored so that both month and day are imputed. [2] 推定值的指示无意暗示推定规则或标准。 例如，如果缺少月份，则插补规则可能会指定忽略所收集的日期值，以便插补月份和日期。

2. As described in Table 3.1.5.1, variables whose names end in TMF are time imputation flags. *TMF variables represent the level