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 | Variable Label | Variable C-code | Definition | Notes | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ACTARMUD | Description of Unplanned Actual Arm | A description of the pathway through the study for a subject who did not follow one of the planned trial arms. | A description of actual treatment for a subject who did not receive treatment described in one of the planned trial arms. | DM | |||||||
| --AGENT | Agent Name | The name of the drug or other material to which susceptibility is tested. | The name of the drug or other material for which resistance is tested. The agent may be used for in vitro testing or may be used in tests for genetic markers or in direct phenotypic drug-sensitivity testing. | Findings-General | |||||||
| TDANCVAR | The name of a variable that specifies the fixed reference point for the start of the planned assessment schedule. | TD | |||||||||
| --ANMETH | Analysis Method | The name of an algorithm, formula or calculation used to obtain a result from intermediate data. | Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). | Findings-General | |||||||
| APID | Associated Persons Identifier | A sequence of characters used to uniquely identify a single associated person, a group of associated persons, or a pool of associated persons. | Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. | All Classes-General | POOLDEF, RELREC, SUPPQUAL | APRELSUB, Associated Persons | |||||
| ARMNRS | Reason Arm and/or Actual Arm is Null | The explanation for why the actual and/or planned arm variables are not populated. | The reason why the actual arm variables are null or why both the planned and actual arm variables are null. It is assumed that if the arm and actual arm variables are null, the same reason applies to both. | DM | |||||||
| --BDAGNT | Binding Agent | The textual description of the agent that's binding to the entity in the --TEST variable. | The textual description of the agent that's binding to the entity in the --TEST variable. The --BDAGNT variable is used to indicate that there is a binding relationship between the entities in the --TEST and --BDAGNT variables, regardless of direction. --BDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the two entities in --TEST and --BDAGNT. In other words, the combination of --TEST and --BDAGNT should describe the thing, the entity, or the analyte being measured, without the need for additional variables. The binding agent may be, but is not limited to, a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent. | Findings-General | |||||||
| --BDSYCD | Body System or Organ Class Code | C170985 | A standardized or dictionary-derived short sequence of characters used to represent the body system or organ class. | MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis. | Events-General | ||||||
| --BEATNO | ECG Beat Number | A numeric identifier that indicates the relative temporal position of an ECG beat. | A sequence number that identifies the beat within an ECG. | All Classes-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 | Collected Ethnicity | An operational field for collecting ethnicity. | A social group characterized by a distinctive social and cultural tradition that is maintained from generation to generation. Members share a common history and origin and a sense of identification with the group. They have similar and distinctive features in their lifestyle habits and shared experiences. They often have a common genetic heritage which may be reflected in their experience of health and disease. When submitting to the FDA, the collected values must be rolled up to the permissible values in ETHNIC. | DM | |||||||
| --CHDY | Day of Obs Rel to Challenge Agent | The number of days from the first date of challenge agent exposure to the date of collection (--DTC), used in study data tabulation. | The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --CHENDY | End Day of Obs Rel to Challenge Agent | 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. | The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --CHRON | Chronicity of Finding | Characterization of the time course of a biological process, which qualifies a particular finding. | Characterization of the duration of a biological process resulting in a particular finding. | Findings-General | |||||||
| --CHSTDY | Start Day of Obs Rel to Challenge Agent | 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. | he actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --COLSRT | Collected Summary Result Type | Indicates the statistical or mathematical property of a collected summary result. | Used to indicate the type of a collected summary result. This is used for summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived by the sponsor using individual source data records, the summary result is represented in ADaM. If a sponsor has both a collected or vendor-provided summary result and a derived summary result, the collected or vendor-provided summary result is represented in SDTM and the derived summary result is represented in ADaM. | Findings-General | |||||||
| --CONC | Agent Concentration | The amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | The amount of drug or other material listed in MSAGENT per unit volume or weight. Used when the agent is part of the prespecified test. Not to be used when the concentration is a result of a test such as minimal inhibitory concentration, IC50, or EC50. | Findings-General | |||||||
| --CONCU | Agent Concentration Units | The unit of measure for the amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | Unit of measure for MSCONC. | Findings-General | |||||||
| CRACE | Collected Race | An operational field for collecting race. | An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control). | 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 | Directionality | An anatomical qualifier that describes the relative location or orientation of a part of the body. | Qualifier for anatomical location or specimen further detailing directionality. | Findings-General Interventions-General Events-General | |||||||
| --DISTR | Distribution Pattern of Finding | A description of the arrangement or dissemination of a finding within an area of focus. | Description of the distribution pattern of a finding within the examined area. | 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 | Ethnicity | 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. | The ethnicity of the subject. Sponsors should refer to FDA guidance regarding the collection of ethnicity data. | DM | |||||||
| --EVDTYP | Medical History Event Date Type | A description of a state, stage or instance of a medical history event to which distinct timing applies. | Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. | Events-General | |||||||
| FOCID | Focus of Study-Specific Interest | 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. | Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed. The value in this variable should have inherent semantic meaning. | All Classes-General | |||||||
| --FTDOSD | Factor for Toxic/Physiologic Dose Descr | The quantity given for the multiplier of the toxicological/physiological dose description (--TDOSD). | The quantity given for the multiplier of --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 | Implantation Site Label | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn). | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study. | Findings-General | |||||||
| INVID | Investigator Identifier | A sequence of characters used to uniquely identify the investigator. | An identifier to describe the Investigator for the study. May be used in addition to the SITEID. Not needed if SITEID is equivalent to INVID. | DM | |||||||
| INVNAM | Investigator Name | The name of the investigator. | Name of the investigator for a site. | DM | |||||||
| --LAT | Laterality | 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. | Qualifier for anatomical location or specimen further detailing laterality. | 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 | Lower Limit of Detection | The lowest threshold (as originally received or collected) for reliably detecting the presence of a substance measured by a specific test. | The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. Units will be those used for --ORRESU. | Findings-General | |||||||
| --LOBXFL | Last Observation Before Exposure Flag | An indication that the record is the last non-missing baseline assessment prior to the date and time in RFXSTDTC. | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. | Findings-General | |||||||
| --LOC | Location Used for the Measurement Location of Administration Location of Event | The anatomical location of the intervention, event, or assessment. | Anatomical location of the subject relevant to the collection of the measurement. Anatomical location of an intervention, such as an injection site. Describes anatomical location relevant for the event. | 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 | Disease Milestone Instance Name | A sequence of characters used to uniquely identify a single occurrence of a disease milestone. | he name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset. This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. | All Classes-General | SM | ||||||
| MIDSDTC | Disease Milestone Instance Date/Time | The start date or date and time of the disease milestone instance, represented in a standardized character format. | The start date/time of the Disease Milestone Instance Name in MIDS. | 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 | |||||||||
| --TMTHSN | Test Method Sensitivity | A description of the relative ability of a test methodology to detect or quantify small amounts of a substance. | The sensitivity of the test methodology with respect to observation, detection, or quantification. | Findings-General | |||||||
| NHOID | Non-Host Organism Identifier | A sequence of characters used to uniquely identify a non-host organism. | Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab. | 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 | Object of the Observation | Names the event or intervention whose property is being measured, tested, or examined. | Used in domains modeled as Findings About Events or Findings About Interventions. Describes the event or intervention whose property is being measured in --TESTCD/--TEST. | Findings About-Findings | |||||||
| --ORDER | An assigned numeric identifier that gives the order of the planned assessment schedule within the trial. | TD | |||||||||
| --ORREF | Reference Result in Original Units | Reference value for the result (as originally received or collected) of the measurement, test, or examination. | Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. | 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 | Planned Duration | The length of time during which an observation is planned to continue, represented in a standardized character format. | Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection. | All Classes-General | |||||||
| --PORTOT | Portion or Totality | Describes a portion of or the totality of an entity of the body, or part of the body, or of a tissue specimen. | Qualifier for anatomical location or specimen further detailing the distribution (i.e., arrangement or apportioning of). | Events-General Findings-General Interventions-General | |||||||
| --PTFL | Point in Time Flag | An indication that the assessment was done, or the specimen or data was collected, at a single point in time. | An indication that the specimen was collected at a single point in time. The value is "Y" or null. | 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 | Race | An arbitrary classification of a taxonomic group that is a division of the human species. | Race of the subject. Sponsors should refer to FDA guidance regarding the collection of race data. | DM | |||||||
| RACEOTH | Speicify Other Race | A free-text field to enter a value for RACE when none of the pre-specified values for RACE are applicable. | A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values. | 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 | Invariant Record Identifier | 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. | Identifier for 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. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain. | 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 | Temporal Relation to Milestone Instance | A textual description of the temporal relationship of the observation to the disease milestone occurrence identified in the Disease Milestone Instance Name. | The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. | All Classes-General | |||||||
| RELTYPE | The cardinality (one or many) of records in a specified domain in a relationship among domains. | RELREC | |||||||||
| --REPNUM | Repetition Number | An integer that identifies the particular occurrence of a repeating activity within a sequence. | The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point or within a visit). | Findings-General | |||||||
| --RESLOC | Result Location of Finding | Anatomical location where the result was observed. | Location where the result was observed (as opposed to the location specified for examination). This location may have a higher degree of specificity than the location specified for examination. | Findings-General | |||||||
| --RESTYP | Result Type | Classifies the kind of result originally reported for the test with respect to properties such as substance concentration, proportion, mass rate and appearance. | Classifies the kind of result (i.e., property type) originally reported for the test. | Findings-General | |||||||
| RFCENDTC | Date/Time of Last Challenge Agent Admin | 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. | 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. Equal to the latest value of AGENDTC for the challenge agent. | DM | |||||||
| RFCSTDTC | Date/Time of First Challenge Agent Admin | 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 | 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. Equal to the earliest value of AGSTDTC for the challenge agent. | 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 | Planned Repro Path Code | C170503 | A short sequence of characters that represents the planned sequence of reproductive stages within each reproductive phase. | A short sequence of characters that represents the planned reproductive path to which the subject was assigned. | DM | TP | |||||
| RPHASE | Repro Phase | A time period in a study that is named for the developmental and reproductive cycle of the study subjects. | Reproductive phase with which the reproductive stage of the reproductive path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used. | 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 | Reason for Treatment Discontinuation | The explanation for why the drug, procedure, or therapy was discontinued. | Reason the treatment was discontinued. | Interventions-General | |||||||
| --RSLSCL | Result Scale | A classification of the scale of the original result value with respect to whether the result is ordinal, nominal, quantitative, or narrative. | Classifies the scale of the original result value with respect to whether the result is, for example, 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 | Restraint Indicator | An indication that the subject was restrained during the course of the activity or assessment. | An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null. An indicator as to whether the animal subject was restrained during the intervention period. Expected values are "Y" or null. | Findings-General Interventions-General | |||||||
| --RSTMOD | Restraint Mode | A description of whether the restraint was physical and/or chemical. | 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 | ||||||||
| --MSCBCE | Molecule Secreted by Cells | The textual description of the molecule secreted by the specified cells. | The textual description of the entity secreted by the cells represented in --TEST. The combination of --TEST and --MSBCE should describe the thing, the entity, or the analyte being measured, without the need for additional variables | 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 | Sex | The assemblage of properties or qualities by which male is distinguished from female. | Sex of the subject. | 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 | Completion Status | 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. | Used to indicate when a question about the occurrence of a prespecified event was not answered. Should be null or have a value of "NOT DONE". Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE". Used to indicate when a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE". | 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 | Reference Result in Standard Format | The standardized reference value for the standardized result of the measurement, test, or examination in character format. | Reference value for the result or finding copied or derived from --ORREF in a standard format. | Findings-General | |||||||
| --STREFN | Numeric Reference Result in Std Units | The standardized reference value for the standardized result of the measurement, test, or examination in numeric format. | Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable. | 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 | Toxic/Physiologic Dose Descr | 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. | 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 | Test Condition | Describes any planned condition imposed on the test system at the time the test is performed. | Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed. | Findings-General | |||||||
| --TSTDTL | Measurement, Test, or Examination Detail | A description of a targeted facet of a test or assessment. | Further description of --TESTCD and --TEST. | Findings-General | |||||||
| --TSTOPO | Test Operational Objective | The textual description of the operational purpose of the test. | The textual description of the high-level purpose of the test at the operational level. | 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 | Day of Obs Relative to Exposure | The number of days from the first date of protocol-specified treatment exposure to the date of collection (--DTC), used in study data tabulation. | The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General | |||||||
| --XENDY | End Day of Obs Relative to Exposure | 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. | The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General | |||||||
| --XSTDY | Start Day of Obs Relative to Exposure | 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. | The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General |
Table 2. Variable Definitions included in Batch 1, extended to additional domains in Batch 2
Note that
| Root Variable Name | Variable Label | Variable C-code | Definition | Notes | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| --CAT1 | Category | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | Findings-General Interventions-General Events-General | TI | ||||||
| --EVAL | Evaluator | C51824 | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Used only for results that are subjective (e.g., assigned by a person or a group). | Findings-General | CO | |||||
| --EVALID | Evaluator Identifier | C117043 | A sequence of characters used to uniquely identify the evaluator(s). | Used to distinguish multiple evaluators with the same role recorded in --EVAL. | Findings-General | CO | |||||
| --REFID | A sequence of characters used to uniquely identify a source of information. | All Classes-General | RELSPEC | ||||||||
| --SCAT1 | Subcategory | C25692 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. | Findings-General Interventions-General Events-General | TI | |||||
| SPDEVID | Sponsor Device Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | All Classes-General | DI | DR | |||||
| --SPEC2 | Specimen Material Type | C70713 | The type of sample material taken from a biological entity. | Findings-General | RELSPEC | ||||||
| TAETORD3 | Planned Order of Element Within Arm | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | All Classes-General | TA | ||||||
| --TEST1 | Name of Measurement, Test, or Exam | C82503 | The standardized or dictionary-derived name of the measurement, test, or examination. | Findings-General | TI | ||||||
| --TESTCD1 | Short Name of Measurement, Test, or Exam | C82503 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | Used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. | 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
| Variable Name | Variable Label | Variable C-Code | Definition | Notes | CDASH | Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Collected Duration | C170992 |
The collected length of time during which an observation continues or the planned duration of the element, represented in a standardized character format. | Used only if collected on the CRF and not derived. | All Classes-General | TE, TT | |||||
| --DY1 | Study Day of Visit/Collection/Exam |
C170993 |
The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General | DM, CO | |||||
| --ENDY | Study Day of End of Observation | C170995 |
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. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General | SE, SV, SM | |||||
| --METHOD2 | Method of Administration Method of Test or Examination |
|
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. | Method of administration of the treatment. Method of the test or examination. | Interventions-General; Findings-General | ||||||
| --SEQ | Sequence Number | C70710 |
A number used in combination with other domain variables to uniquely identify records within the domain. | May be any valid number (including decimals) and does not have to start at 1. Datasets that do not contain subject data, such as the Trial Summary (TS) domain and the Device Tracking (DT) domains, use --SEQ as a sequence number to ensure uniqueness within the dataset. | 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 | Name of Treatment | C82542 |
The reported name of the substance, treatment, or procedure administered to or used by the subject. | The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation. | Interventions-General | ||||||
| --LOT | Lot Number | C70848 |
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. | Lot number for the intervention described in --TRT. | Interventions-General | ||||||
| --USCHFL | Unscheduled Flag | C170510 |
An indication that the performed test or observation was done at a time that was not planned. | 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. | Interventions-General; Events-General; Findings-General | ||||||
| --BLFL | Baseline Flag | C82526 |
An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation. | Indicator used to identify a baseline value. Should be "Y" or null. | Findings-General | ||||||
| --GRPID | Group ID | C170996 | 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. | 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. | All Classes-General | ||||||
| --LNKID | Link ID | C117050 |
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. | Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. | This may be a one-to-one or a one-to-many relationship. | All Classes-General | |||||
| --LNKGRP | Link Group ID | C117049 |
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. | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | This will usually be a many-to-one relationship. | All Classes-General | |||||
| --DTC1 | Date/Time of Collection |
C82515 |
The date or date and time of the assessment or the specimen or data collection, represented in a standardized character format. | Collection date and time of an observation. | All Classes-General | DM, CO | |||||
| --STDTC | Start Date/Time of Observation | C82517 |
The start date or date and time of an intervention, event, element, or subject reproductive phase, represented in a standardized character format. | Start date/time of an observation. | The start date of a Findings class record is stored in the --DTC variable. | All Classes-General | |||||
| --ENDTC | End Date/Time of Observation | C82516 |
The end date or date and time of an intervention, event, finding, element, or subject reproductive phase, represented in a standardized character format. | End date/time of the observation. | All Classes-General | SE, SV, SM, SJ | |||||
| --STDY | Study Day of Start of Observation | Study Day of Start of Observation |
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. | Actual study day of start of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General | |||||
| --ENDY | Study Day of End of Observation | Study Day of End of Observation |
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. | Actual study day of end of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General |
- 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.