Information for Reviewers
The variables defined in Batch 1 were based on SDTM v1.4 and the CDASHIG v1.0. The variables were from the SDTM tables for general observation classes and the SDTM table for the Demographics domain, plus CDASH variables for the Demographics domain. Some variables were put on hold in Batch 1. The complete set of defined variables is in SDTM Variable Definitions - COMPLETED 2019 Review,
Explain root variables.
Batch 2 includes variables from all the SDTM tables, and includes variables from later versions of the SDTM, including variables from the upcoming SDTM v2.0.
- Table 1 includes definitions which were not included in Batch 1 or were placed on hold in Batch 1.
- Table 2 includes variable definitions in Batch 1 for variables which appear in additional SDTM tables, and which were unchanged.
- Table 3 includes variable definitions which were included in Batch 1, but were updated in Batch 2. Most changes were made to cover variables in the additional SDTM tables.
Table 1. Root variable definitions added in Batch 2
| Root Variable Name | Definition | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|
| ACTARMUD | A description of the pathway through the study for a subject who did not follow one of the planned trial arms. | DM | ||||||
| --AGENT | The name of the drug or other material to which susceptibility is tested. | Findings-General | ||||||
| TDANCVAR | The name of a variable that specifies the fixed reference point for the start of the planned assessment schedule. | TD | ||||||
| --ANMETH | The name of an algorithm, formula or calculation used to obtain a result from intermediate data. | Findings-General | ||||||
| APID | A sequence of characters used to uniquely identify a single associated person, a group of associated persons, or a pool of associated persons. | All Classes-General | POOLDEF, RELREC, SUPPQUAL | APRELSUB, Associated Persons | ||||
| ARMNRS | The explanation for why the actual and/or planned arm variables are not populated. | DM | ||||||
| --BDAGNT | The textual description of the agent that's binding to the entity in the --TEST variable. | Findings-General | ||||||
| --BDSYCD | A standardized or dictionary-derived short sequence of characters used to represent the body system or organ class. | Events-General | ||||||
| --BEATNO | A numeric identifier that indicates the relative temporal position of an ECG beat. | Findings-General | ||||||
| --BRANCH | A decision point condition which determines, in whole or in part, the subject's assignment to an arm and thus their transition to the subsequent element. | TA, TP | ||||||
| CETHNIC | An operational field for collecting ethnicity. | DM | ||||||
| --CHDY | The number of days from the first date of challenge agent exposure to the date of collection (--DTC), used in study data tabulation. | All Classes-General | ||||||
| --CHENDY | The number of days from the first date of challenge agent exposure to the end of an intervention or event (--ENDTC), used for study data tabulation. | All Classes-General | ||||||
| --CHRON | Characterization of the time course of a biological process, which qualifies a particular finding. | Findings-General | ||||||
| --CHSTDY | The number of days from the first date of challenge agent exposure to the start of an intervention or event (--STDTC), used for study data tabulation. | All Classes-General | ||||||
| --COLSRT | Indicates the statistical or mathematical property of a collected summary result. | Findings-General | ||||||
| --CONC | The amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | Findings-General | ||||||
| --CONCU | The unit of measure for the amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | Findings-General | ||||||
| CRACE | An operational field for collecting race. | DM | ||||||
| TMDEF | The description of an event or activity that can be anticipated in the course of a disease, but whose timing is not controlled by the study schedule. | TM | ||||||
| --DIR | An anatomical qualifier that describes the relative location or orientation of a part of the body. | Findings-General Interventions-General Events-General | ||||||
| --DISTR | A description of the arrangement or dissemination of a finding within an area of focus. | Findings-General | ||||||
| ELEMENT | A descriptive name for a block of time within one or more arms, wherein protocol-defined activities take place. | SE | TE, TA | |||||
| --ENRL | Identifies the condition or criterion that defines the end of a planned period of time within the study. | TE, TT, TV | ||||||
| ETCD | A short sequence of characters that represents the trial element. | SE | TE, TA | |||||
| ETHNIC | An arbitrary classification of the social group a person belongs to, and either identifies with or is identified with by others, as a result of a complex of cultural, biological, geographical and other factors. | DM | ||||||
| --EVDTYP | A description of a state, stage or instance of a medical history event to which distinct timing applies. | Events-General | ||||||
| FOCID | A sequence of characters used to uniquely identify the protocol-specified discrete part of a subject or specimen (the experimental unit) where the measurement, test, intervention, or examination was performed. | All Classes-General | ||||||
| --FTDOSD | The quantity given for the multiplier of the toxicological/physiological dose description (--TDOSD). | Interventions-General | ||||||
| IDVAR | A variable that contains the name of an operational variable, used in combination with other identifier variables, that is used in specifying records that are related. | CO | RELREC, SUPPQUAL | |||||
| IDVARVAL | A variable that contains the value of the operational variable, used in combination with other identifier variables, that is used in specifying records that are related. | CO | RELREC, SUPPQUAL | |||||
| --IMPLBL | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn). | Findings-General | ||||||
| INVID | A sequence of characters used to uniquely identify the investigator. | DM | ||||||
| INVNAM | The name of the investigator. | DM | ||||||
| --LAT | Referring to the side or sides of the body, or part of the body, relevant to the anatomical location of the intervention, event, or assessment. | Events-General Findings-General Interventions-General | ||||||
| LEVEL | The generation number of a biospecimen in relation to the collected biospecimen that is considered the first generation. | RELSPEC | ||||||
| --LLOD | The lowest threshold (as originally received or collected) for reliably detecting the presence of a substance measured by a specific test. | Findings-General | ||||||
| --LOBXFL | An indication that the record is the last non-missing baseline assessment prior to the date and time in RFXSTDTC. | Findings-General | ||||||
| --LOC | The anatomical location of the intervention, event, or assessment. | Findings-General Interventions-General Events-General | ||||||
| --MAXPAI | The upper limit of the allowed range for the interval between disease assessments in the planned assessment schedule, represented in a standardized character format. | TD | ||||||
| MIDS | A sequence of characters used to uniquely identify a single occurrence of a disease milestone. | All Classes-General | SM | |||||
| MIDSDTC | The start date or date and time of the disease milestone instance, represented in a standardized character format. | All Classes-General | ||||||
| MIDSTYPE | A short description of a disease milestone. | SM | TM | |||||
| TDMINPAI | The lower limit of the allowed range for the interval between disease assessments in the planned assessment schedule, represented in a standardized character format. | TD | ||||||
| --MTHSEN | A description of the relative ability of a test methodology to detect or quantify small amounts of a substance. | Findings-General | ||||||
| NHOID | A sequence of characters used to uniquely identify a non-host organism. | All Classes-General | OI | |||||
| --NUMRPT | The planned number of assessments in the assessment schedule, or, if the number of assessments is not limited in the protocol, the maximum number of assessments that actually occurred. | TD | ||||||
| --OBJ | Names the event or intervention whose property is being measured, tested, or examined. | Findings About-Findings | ||||||
| --ORDER | An assigned numeric identifier that gives the order of the planned assessment schedule within the trial. | TD | ||||||
| --ORREF | Reference value for the result (as originally received or collected) of the measurement, test, or examination. | Findings-General | ||||||
| PARENT | The identifier for the immediate progenitor of a biospecimen. | RELSPEC | ||||||
| --PARM | The standardized or dictionary-derived name of an attribute for the topic of the domain. | TS, TX, AC | DI, OI | |||||
| --PARMCD | A standardized or dictionary-derived short sequence of characters used to represent an attribute for the topic of the domain. | TS, TX, AC | DI, OI | |||||
| --PDUR | The length of time during which an observation is planned to continue, represented in a standardized character format. | All Classes-General | ||||||
| --PORTOT | Describes a portion of or the totality of an entity of the body, or part of the body, or of a tissue specimen. | Events-General Findings-General Interventions-General | ||||||
| --PTFL | An indication that the assessment was done, or the specimen or data was collected, at a single point in time. | All Classes-General | ||||||
| QEVAL | The role of the person(s) providing the value of the non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | SUPPQUAL | ||||||
| QLABEL | The long name of a non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | SUPPQUAL | ||||||
| QNAM | The short name of a non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | SUPPQUAL | ||||||
| QORIG | An indication of how the value of the non-standard variable originated in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | SUPPQUAL | ||||||
| QVAL | The value of the non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | SUPPQUAL | ||||||
| RACE | An arbitrary classification of a taxonomic group that is a division of the human species. | DM | ||||||
| RACEOTH | A free-text field to enter a value for RACE when none of the pre-specified values for RACE are applicable. | DM | ||||||
| RDEVID | A sequence of characters used to uniquely identify the device that is related to the identified single associated person, group of associated persons, or pool of associated person | APRELSUB, Associated Persons | ||||||
| RDOMAIN | An operational variable that holds the domain abbreviation for the domain in which related records are located. | CO | RELREC, SUPPQUAL | |||||
| --RECID | A sequence of characters used to uniquely identify a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. | All Classes-General | ||||||
| --REF | A sponsor-defined description of the source of a particular comment. | CO | ||||||
| RELID | A sequence of characters used to uniquely identify related records within a dataset (the Related Records dataset) used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. | RELREC | ||||||
| RELMIDS | A textual description of the temporal relationship of the observation to the disease milestone occurrence identified in the Disease Milestone Instance Name. | All Classes-General | ||||||
| RELTYPE | The cardinality (one or many) of records in a specified domain in a relationship among domains. | RELREC | ||||||
| --REPNUM | An integer that identifies the particular occurrence of a repeating activity within a sequence. | Findings-General | ||||||
| --RESLOC | Anatomical location where the result was observed. | Findings-General | ||||||
| --RESTYP | Classifies the kind of result originally reported for the test with respect to properties such as substance concentration, proportion, mass rate and appearance. | Findings-General | ||||||
| RFCENDTC | The end date or date and time of the last exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. | DM | ||||||
| RFCSTDTC | The start date or date and time of the first exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format | DM | ||||||
| --RL | Rule that expresses the criterion in computer-executable form. | TI | ||||||
| RPATH | A planned sequence of reproductive stages within each reproductive phase. | TP | ||||||
| RPATHCD | A short sequence of characters that represents the planned sequence of reproductive stages within each reproductive phase. | DM | TP | |||||
| RPHASE | A time period in a study that is named for the developmental and reproductive cycle of the study subjects. | All Classes-General | SJ | TP | ||||
| RPRFDY | An integer used to represent the start day of the reproductive phase. | TP | ||||||
| --RPT | An indication as to whether a disease milestone can occur more than once for a subject. | TM | ||||||
| --RSDISC | The explanation for why the drug, procedure, or therapy was discontinued. | Interventions-General | ||||||
| --RSLSCL | A classification of the scale of the original result value with respect to whether the result is ordinal, nominal, quantitative, or narrative. | Findings-General | ||||||
| RSTAGE | A descriptive name for the planned study activities that occur during a subject reproductive phase. | SJ | TP, TT | |||||
| RSTGCD | A short sequence of characters that represents a descriptive name for the planned study activities that occur during a subject reproductive phase. | SJ | TP, TT | |||||
| --RSTIND | An indication that the subject was restrained during the course of the activity or assessment. | Findings-General Interventions-General | ||||||
| --RSTMOD | A description of whether the restraint was physical and/or chemical. | Findings-General Interventions-General | ||||||
| RSUBJID | A sequence of characters used to uniquely identify the study subject or pool of subjects that is related to the identified single associated person, group of associated persons, or pool of associated persons. Or a sequence of characters used to uniquely identify the study subject or pool of subjects that is related to another study subject or pool of study subjects. | RELSUB | APRELSUB, Associated Persons | |||||
| --SCMBCL | The textual description of the molecule secreted by the specified cells. | Findings-General | ||||||
| SET | A descriptive name of a group of subjects with shared experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. | TS | ||||||
| SEX | The assemblage of properties or qualities by which male is distinguished from female. | DM | ||||||
| SREL | A description of the relationship between a single associated person, a group of associated persons, or a pool of associated persons and a study subject, a pool of study subjects, a device, or the study as a whole. | RELSUB | APRELSUB, Associated Persons | |||||
| --STAT | An indication that no result to a test (or set of tests) is present, or that a question about the occurrence of a prespecified event or intervention has no response. | Events-General Findings-General Interventions-General | ||||||
| --STGORD | An assigned numeric identifier that gives the planned order of the reproductive stage within the reproductive path of the study. | TP | ||||||
| --STOFF | The interval of time from the anchor value to the first assessment in the planned assessment schedule, represented in a standardized character format. | TD | ||||||
| --STREFC | The standardized reference value for the standardized result of the measurement, test, or examination in character format. | Findings-General | ||||||
| --STREFN | The standardized reference value for the standardized result of the measurement, test, or examination in numeric format. | Findings-General | ||||||
| --STRL | Identifies the condition or criterion that defines the beginning of a planned period of time within the study. | TE, TT, TV | ||||||
| --TDOSD | A description of a statistically derived estimate of a dose with a certain toxicological or physiological effect in a population, based on data from a dose-response study. | Interventions-General | ||||||
| --TGTPAI | The planned interval between disease assessments n the planned assessment schedule, represented in a standardized character format. | TD | ||||||
| --TRANS | A decision point condition which allows a subject to move to an element other than the next element in the planned sequence within the arm. | TA | ||||||
| --TSTCND | Describes any planned condition imposed on the test system at the time the test is performed. | Findings-General | ||||||
| --TSTDTL | A description of a targeted facet of a test or assessment. | Findings-General | ||||||
| --TSTOPO | The textual description of the operational purpose of the test. | Findings-General | ||||||
| --UPDES | A description of an element, visit, or subject reproductive stage that differs from those that are in the protocol plan. | SE, SV, SJ | ||||||
| --VAL | The result or response for the parameter, or text of a comment. | CO | AC, TS, TX | DI, OI | ||||
| --VALCD | A standardized or dictionary-derived short sequence of characters used to represent the result or response for the parameter. | TS, AC | ||||||
| --VALNF | A standardized or dictionary-derived short sequence of characters describing the reason why the parameter value (--VAL) is not populated. | TS, AC | ||||||
| --VALU | The unit of measure for the result for the parameter. | AC | ||||||
| --VCDREF | The name of the reference terminology from which the parameter value (–VAL) and parameter value code (–VALCD) are taken or the name of the format standard used to represent the parameter value (--VAL). | AC, TS | ||||||
| --VCDVER | The version of the reference terminology from which the parameter value (–VAL) and parameter value code (–VALCD) are taken. | AC, TS | ||||||
| --VERS | The protocol version identifier of the Inclusion/Exclusion criteria. | TI | ||||||
| --XDY | The number of days from the first date of protocol-specified treatment exposure to the date of collection (--DTC), used in study data tabulation. | All Classes-General | ||||||
| --XENDY | The number of days from the first date of protocol-specified treatment exposure to the end of an intervention or event (--ENDTC), used for study data tabulation. | All Classes-General | ||||||
| --XSTDY | The number of days from the first date of protocol-specified treatment exposure to the start of an intervention or event (--STDTC), used for study data tabulation. | All Classes-General |
Table 2. Variable Definitions included in Batch 1, extended to additional domains in Batch 2
Note that
| Root Variable Name | Definition | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|
| --CAT1 | A grouping or classification of the topic of the finding, event, or intervention. | Findings-General Interventions-General Events-General | TI | |||||
| --EVAL | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Findings-General | CO | |||||
| --EVALID | A sequence of characters used to uniquely identify the evaluator(s). | Findings-General | CO | |||||
| --REFID | A sequence of characters used to uniquely identify a source of information. | All Classes-General | RELSPEC | |||||
| --SCAT1 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | Findings-General Interventions-General Events-General | TI | |||||
| SPDEVID | A sequence of characters used by the sponsor to uniquely identify a specific device. | All Classes-General | DI | DR | ||||
| --SPEC2 | The type of sample material taken from a biological entity. | Findings-General | RELSPEC | |||||
| TAETORD3 | ||||||||
| --TEST1 | The standardized or dictionary-derived name of the measurement, test, or examination. | Findings-General | TI | |||||
| --TESTCD1 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | Findings-General | TI |
- The TI domain includes variables IETESTCD, IETEST, IECAT, and IESCAT. Although "IE" is not the domain code for the TI domain, these variables are considered instantiations of the root variables --TESTCD, --TEST, --CAT, and --SCAT.
- The variable SPEC in the RELSPEC domain is not named with a two-variable domain code prefix, but is considered to be an instantiation of the root variable --SPEC.
- The variable TAETORD is a timing variable in the general observation classes. In the TA domain, the first two characters of the variable TAETORD are the domain code. However, TAETORD is considered to be an instantiation of the root variable TAETORD, rather than a root variable --ETORD.
Table 3. Changes to Batch 1 root variable definitions
| Role | Variable Name | Variable Label | Type | Variable Name (no prefix) | Definition | CDASH | Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons | Implementation Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ARM | The name of the planned arm to which the subject was assigned. The name of a planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path. | DM | TA, TV | ||||||||||
| --DUR |
The collected length of time during which an observation continues or the planned duration of the element, represented in a standardized character format. | All Classes-General | TE, TT | ||||||||||
| --DY1 |
The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | All Classes-General | DM, CO | ||||||||||
| --ENDY |
The number of days from the sponsor-defined reference start date to the end of an intervention, event, finding, element, or subject reproductive phase (--ENDTC), used for study data tabulation. | All Classes-General | SE, SV, SM | ||||||||||
| --METHOD2 |
A process or systematic course of actions for performing a measurement, examination or test, or the method of intervention administration in the non-clinical context. | Interventions-General; Findings-General | |||||||||||
| --SEQ |
A number used in combination with other domain variables to uniquely identify records within the domain. | All Classes-General | CO, SE, SJ, SM | AC, TS, TX | DI, OI | ||||||||
| --SETCD |
The short sequence of characters used to represent the trial set. | DM | |||||||||||
| --TRT |
The reported name of the substance, treatment, or procedure administered to or used by the subject. | Findings-General | |||||||||||
| Record Qualifier | --LOT | Lot Number | Char | LOT |
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. | Interventions-General | Lot number for the intervention described in --TRT. | ||||||
| Record Qualifier | --USCHFL | Unscheduled Flag | Char | USCHFL |
An indication that the performed test or observation was done at a time that was not planned. | Interventions-General; Events-General; Findings-General | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used. | ||||||
| Record Qualifier | --BLFL | Baseline Flag | Char | BLFL |
An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation. | Findings-General | Indicator used to identify a baseline value. Should be "Y" or null. | ||||||
| Identifier | --GRPID | Group ID | Char | GRPID | A sequence of characters used to identify a group of related records. In domains that represent study subject data, the records are grouped within a subject. | All Classes-General | Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in See also Section 4.1.6, Trial Summary Information and Section 4.1.7, Challenge Agent Characterization. | ||||||
| Identifier | --LNKID | Link ID | Char | LNKID |
A sequence of characters used to uniquely identify a record, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | All Classes-General | Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. | ||||||
| Identifier | --LNKGRP | Link Group ID | Char | LNKGRP |
A sequence of characters used to uniquely identify a group of records, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | All Classes-General | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | ||||||
| Timing | --DTC1 | Date/Time of Collection | Char | DTC |
The date or date and time of the assessment or the specimen or data collection, represented in a standardized character format. | All Classes-General | DM, CO | Collection date and time of an observation. | |||||
| Timing | --STDTC | Start Date/Time of Observation | Char | STDTC |
The start date or date and time of an intervention, event, element, or subject reproductive phase, represented in a standardized character format. | All Classes-General | Start date/time of an observation. | ||||||
| Timing | --ENDTC | End Date/Time of Observation | Char | ENDTC |
The end date or date and time of an intervention, event, finding, element, or subject reproductive phase, represented in a standardized character format. | All Classes-General | SE, SV, SM, SJ | End date/time of the observation. | |||||
| Timing | --STDY | Study Day of Start of Observation | Num | STDY |
The number of days from the sponsor-defined reference start date to the start of an intervention, event, element, visit, milestone or subject reproductive phase (--STDTC), used for study data tabulation. | All Classes-General | Actual study day of start of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. | ||||||
| Timing | --ENDY | Study Day of End of Observation | Num | ENDY |
The number of days from the sponsor-defined reference start date to the end of an intervention, event, finding, element, or subject reproductive phase (--ENDTC), used for study data tabulation. | All Classes-General | Actual study day of end of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. |
- In Batch 1, DMDTC and DMDY were defined separately. The Demographics-specific definitions are being removed in Batch 2. DMDY and DMDTC are considered instantiations of the root variables --DY and --DTC.
- In Batch 1, EXMETHOD was defined separately. The Exposure-specific definition is being removed in Batch 2. EXMETHOD is considered an instantiation of the root variable --METHOD.