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Information for Reviewers

The CDISC variable definitions team, comprising representatives from the SDS, CDASH, ADaM, SEND, and Controlled Terminology teams, has developed core definitions for 193 variables for the Demographics domain and the Findings, Events, and Interventions general observation classes. These variables include Identifier and Timing variables. The definitions for public review are located in the Final Draft Definition column. These definitions are based on information contained in SDTMIG v3.2, SDTM v1.6, CDASHIG v2.0, CDASH Model v1.0, SENDIG v3.1, and SENDIG-DART v1.1.

These definitions are intended to define the underlying semantics of the model variables; as such they are defined more broadly than their usage in a single observation class. Because of this, the definition may be at a different level of granularity than the information in the CDISC Notes/CDISC Description column. The definitions should be considered additional, supplementary information and are not intended to replace the information in the CDISC Notes/CDISC Description columns within the tables of CDISC standards documents.

SDTM tables currently include a column called "Description" which may include descriptive text that provides a loose definition of the variable along with implementation notes, examples and other content. SDTM Variable Definitions are expected to be incorporated into the SDTM in a future release in which the current contents of the "Description" column will be separated into several columns:

  • Variable Definition
  • Usage (e.g., use restricted to non-clinical studies, or use restricted to a particular domain)
  • Examples
  • Revised Description column for other information, such as length restrictions and other implementation notes. Current definition-like text would be removed from the Description column.

A small subset of these variables are designated as "ON HOLD" in the Final Draft Definition column. The team was unable to come up with definitions for these particular variables owing to additional development work that is being undertaken by other CDISC teams to refine their meaning and usage. These definitions will be developed at a later date. The team also acknowledges that additional variables have been added to later versions of the SDTM and CDASHIG that are not included in this release. The team will embark on a second batch of variable definition development after this first set is complete.

Variable NameVariable LabelNCI C-code

Final Draft Definition

*(For Review. We will review comments made on this content.)

CDISC Notes/CDISC Description

*(For reference only. We will not review comments made on this content.)

InterventionsEventsFindingsIdentifiersTimingDemographics
--ACNAction Taken with Study TreatmentC49499

An action taken with study treatment SDSVAR-118 - Getting issue details... STATUS as the result of the event.

Describes changes made to the study treatment as a result of the event. Examples: DOSE INCREASED, DOSE NOT CHANGED. x    
--ACNDEVAction Taken with DeviceC117037

An action taken with a device SDSVAR-119 - Getting issue details... STATUS as the result of the event.

Action taken with respect to a device in a study, which may or may not be the device under study. x    
--ACNOTHOther Action TakenC82509An action taken, unrelated to study treatment, as the result of the event.Describes other actions taken as a result of the event that are unrelated to dose adjustments of study treatment. x    
--ACPTFLAccepted Record FlagC117038An indication that a record is the endorsed assessment. SDSVAR-124 - Getting issue details... STATUS SDSVAR-115 - Getting issue details... STATUS In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered, by an independent assessor, to be the accepted evaluation. Expected to be Y or null.  x   
ACTARMDescription of Actual ArmC117448The name of the arm in which the subject actually participated.Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM SDSVAR-116 - Getting issue details... STATUS will be “Unplanned Treatment”. Randomized subjects who were not treated will be given a value of “Not Treated”. Values should be “Screen Failure” for screen failures and “Not Assigned” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases.     x
ACTARMCDActual Arm CodeC117449A short sequence of characters that represents the arm in which the subject actually participated.Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be “SCRNFAIL” for screen failures and “NOTASSGN” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases. ACTARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ACTARMCD SDSVAR-117 - Getting issue details... STATUS is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover trials.     x
--ADJReason for Dose AdjustmentC82555The explanation given for why a dose was changed as compared to a previous dose. SDSVAR-125 - Getting issue details... STATUS Describes reason or explanation of why a dose is adjusted. Examples: ADVERSE EVENT, INSUFFICIENT RESPONSE, NON-MEDICAL REASON.x     
AGEAgeC25150A numeric representation of the elapsed time since birth at a specific point in time defined for the trial, used for study data tabulation.Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns).     x
AGETXT VDT-69 - Getting issue details... STATUS  C90352The age at a specific point in time defined for the trial, expressed as a range.Examples: infant, elderly, in their 20s.     x
AGEUAge UnitsC50400The unit of time used to express the age, using standardized values.Units associated with AGE.     x
--ANMETHAnalysis MethodC117039ON HOLDAnalysis 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 or a genetic sequence).  x   
--ANTREGAnatomical RegionC12680The specific anatomical or biological region of a tissue or organ specimen.Defines the specific anatomical or biological region of a tissue or organ specimen, or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. Examples: CORTEX, MEDULLA, MUCOSA  x   
ARMDescription of Planned ArmC15538The name of the planned arm to which the subject was assigned.Name of the Arm to which the subject was assigned.     x
ARMCDPlanned Arm CodeC83216A short sequence of characters that represents the planned arm to which the subject was assigned.ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20.     x
--BDSYCDBody System or Organ Class CodeC117040A 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. VDT-66 - Getting issue details... STATUS
 x    
--BLFLBaseline FlagC82526An indication that the record is the baseline assessment, used in study data tabulation.Indicator used to identify a baseline value. Should be Y or null.  x   
--BODSYSBody System or Organ ClassC12919A standardized or dictionary derived name for the body system or organ class.Body system or system organ class assigned for analysis from a standard hierarchy (e.g., MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS. x    
BRTHDTCDate/Time of BirthC83217The date or date and time of birth, represented in a standardized character format.Date/time of birth of the subject.     x
--CATCategoryC25372A grouping or classification of the topic of the finding, event, or intervention.Used to define a category of topic-variable values. Examples: HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMILTON DEPRESSION SCALE, SF36, MICRO ARRAY, EGFR MUTATION ANALYSIS.xxx   
--CDUR C83168A numeric representation of the collected amount of time during which an observation continues.
The duration of the substance use. (CDASH only) VDT-68 - Getting issue details... STATUS
    x 
--CDURU C82584The unit of time used to express the collected length of time during which an observation continues.Units for SUCDUR (e.g., WEEKS, MONTHS, YEARS). (CDASH only)    x 
CETHNIC ARPROJECT-731 - Getting issue details... STATUS
CNEWON HOLDCDASH Draft definition (CDASH v2.0): A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. (CDASH only)




x
--CLASClassC25346

A standardized or dictionary-derived name for a grouping of drugs, procedures, or therapies. VDT-67 - Getting issue details... STATUS

Class for a medication or treatment, often obtained from a coding dictionary.x     
--CLASCDClass CodeC82501A standardized or dictionary-derived short sequence of characters used to represent a grouping of drugs, procedures, or therapies.Used to represent code for --CLAS.x     
--CONTRTConcomitant or Additional Trtmnt GivenC53630An indication as to whether a non-study treatment was given because of the occurrence of the event.Was another treatment given because of the occurrence of the event? Valid values are “Y” and “N”. x    
COUNTRYCountryC25464The country in which the investigational site is located.Country of the investigational site in which the subject participated in the trial.     x
CRACE ARPROJECT-732 - Getting issue details... STATUS  CNEWON HOLDCDASH Draft definition (CDASH v2.0): An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control and Prevention). (CDASH only)     x
--CSTATEConsciousness StateC88429The subject's level of consciousness.The consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS  x   
--DECODDictionary-Derived TermC82977Standardized or dictionary-derived text for the description of an event or intervention.Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA).xx    
--DETECTTime in Days to DetectionC117041The number of days from the start of dosing to the earliest detection of a condition or pathogen.The number of days from the start of dosing to the earliest detection of a condition or pathogen.    x 
--DIRDirectionalityC54215See Findings SDS-1412 - Getting issue details... STATUS Qualifier for anatomical location further detailing directionality of intervention administration. Examples: ANTERIOR, LOWER, PROXIMAL.xxx   
DMDTCDate/Time of CollectionC83243The date or date and time of demographic data collection, represented in a standardized character format.Date/time of demographic data collection.     x
DMDYStudy Day of CollectionC83244The actual study day of demographic data collection derived relative to the sponsor-defined reference start date.Study day of collection measured as integer days.     x
DOMAINDomain AbbreviationC49556An abbreviation for a collection of observations, with a topic-specific commonality.Two-character abbreviation for the domain most relevant to the observation. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.   x x
--DOSEDoseC25488The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration.Amount of --TRT given. Not populated when --DOSTXT is populated.x     
--DOSFRMDose FormC42636The shape or configuration in which an agent (e.g., drug, substance, radiation) is physically presented.Dose form for the treatment. Examples: TABLET, CAPSULE.x     
--DOSFRQDosing Frequency per IntervalC15682The number of times that an agent (e.g., drug, substance, radiation) is administered per unit of time.Usually expressed as the number of doses given per a specific interval. Examples: Q2H, QD, PRN.x     
--DOSRGMIntended Dose RegimenC71137The planned schedule for the administration of an agent (e.g., drug, substance, radiation).Text description of the (intended) schedule or regimen for the Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF.x     
--DOSTOTTotal Daily DoseC70888The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed on a single day.Total daily dose of --TRT using the units in --DOSU. Used when dosing is collected as Total Daily Dose.x     
--DOSTXTDose DescriptionC70961A textual description of the quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration.Dosing information collected in text form. Examples: <1 per day, 200-400. Not populated when --DOSE is populated.x     
--DOSUDose UnitsC73558The unit of measure for the agent (e.g., drug, substance, radiation), using standardized values.Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: ng, mg, mg/kg.x     
--DRVFLDerived FlagC81197An indication that the measurement or finding is not a collected value but is processed or computed by the sponsor from collected data.Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be Y or null.  x   
--DTCDate/Time of CollectionC82515The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format.Collection date and time of an observation represented in IS0 8601 character format.    x 
DTHDTCDate/Time of DeathC117450The date or date and time of death, represented in a standardized character format.Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-trial database.     x
DTHFLSubject Death FlagC117451An indication that the subject died.Indicates the subject died. Should be Y or null. Should be populated even when the death date is unknown.     x
--DTHRELRelationship to DeathC82563An indication that a particular finding is related to the cause of death.Describes the relationship of a particular finding to the death of a subject. Examples: Y, N, U.  x   
--DURDurationC25330The collected length of time during which an observation continues, represented in a standardized character format.Collected duration of an event, intervention, or finding represented in ISO 8601 character format. Used only if collected on the CRF and not derived.    x 
--DYStudy Day of Visit/Collection/ExamC82437The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation.Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.    x 
--ELTMPlanned Elapsed Time from Time Point RefC82572The interval of time between a planned time point and a fixed reference point, represented in a standardized character format.Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference (--TPTREF) such as “Previous Dose” or “Previous Meal”. This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.    x 
--ENDTCEnd Date/Time of ObservationC82516The end date or date and time of an intervention, event, or finding, represented in a standardized character format.End date/time of the observation represented in IS0 8601 character format.    x 
--ENDYStudy Day of End of ObservationC82569The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (–ENDTC), used for study data tabulation.Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.    x 
--ENINTPlanned End of Assessment IntervalC117042The end of a planned assessment interval relative to a reference time point, represented in a standardized character format.The end of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).    x 
--ENRFEnd Relative to Reference PeriodC82557The characterization of the end of an observation relative to the study reference period.

Identifies the end of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.

Note: This variable will be deprecated (phased out) in a future (post-SDTM v1.4) release. The functionality of this variable can be replaced by the use of --ENRTPT with --ENTPT = RFENDTC.

    x 
--ENRTPTEnd Relative to Reference Time PointC82558The characterization of the end of an observation relative to a reference time point.Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.    x 
--ENTPTEnd Reference Time PointC82574The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation.Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --ENRTPT. Examples: "2003-12-25", "VISIT 2".    x 
EPOCHEpochC71738A time period defined in the protocol with a study-specific purpose.Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. (See Section 3.2.2).    x 
ETHNICEthnicityC16564ON HOLDThe ethnicity of the subject. Sponsors should refer to “Collection of Race and Ethnicity Data in Clinical Trials” (FDA, September 2005) for guidance regarding the collection of ethnicity (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm).     x
--EVALEvaluatorC51824The role of the person(s) providing an evaluation, appraisal, or interpretation.Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: ADJUDICATION COMMITTEE, INDEPENDENT ASSESSOR, RADIOLOGIST.  x   
--EVALIDEvaluator IdentifierC117043A sequence of characters used to uniquely identify the evaluator(s).Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST1 or RADIOLOGIST2  x   
--EVINTXEvaluation Interval TextC117044A textual description of the planned time interval for which an observation is assessed, where the interval is not able to be represented in a standardized character format.Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: LIFETIME, LAST NIGHT, RECENTLY, OVER THE LAST FEW WEEKS.    x 
--EVLINTEvaluation IntervalC82534The planned time interval for which an observation is assessed, represented in a standardized character format.Duration of interval associated with an observation such as a finding --TESTCD, represented in ISO 8601 character format. Example: -P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF-36.    x 
--EXCLFLExclude from StatisticsC117045An indication that the result is to be excluded from all calculations.Indicates whether the values in the result variables for this record should be excluded from summary statistical calculations such as Mean, Standard Deviation, and Count (and others). Expected to be Y or null. --EXCLFL should not be used when --STAT is NOT DONE. Not to be used with human clinical trials.  x   
EXMETHODMethod of AdministrationC119826Method of administration of the treatment.Method of administration of the treatment. Not to be used with human clinical trials.x     
--FASTFasting StatusC93566An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time.Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.x x   
FETUSIDFetus IdentifierCNEWA sequence of characters used to uniquely identify a fetus associated with a maternal subject, for a particular prenatal evaluation.Identifier used to identify a fetus from a maternal subject for prenatal evaluations. FETUSID uniquely identifies a fetus within a subject. Not to be used with human clinical trials.   x  
--GRPIDGroup IDC82529A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary dataset.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 the Trial Summary dataset (Section 3.4).   x  
--HLGTHigh Level Group TermC71889The high-level group term from the primary hierarchy assigned to the event from the MedDRA dictionary.MedDRA High Level Group Term from the primary path. x    
--HLGTCDHigh Level Group Term CodeC117046The high-level group term code from the primary hierarchy assigned to the event from MedDRA.MedDRA High Level Group Term code from the primary path. x    
--HLTHigh Level TermC71880The high-level term from the primary hierarchy assigned to the event from MedDRA.MedDRA High Level Term from the primary path. x    
--HLTCDHigh Level Term CodeC117047The high-level term code from the primary hierarchy assigned to the event from MedDRA.MedDRA High Level Term code from the primary path. x    
--INDCIndicationC41184The sign, symptom, or condition that is the basis for initiation of a treatment.Denotes the indication for the intervention (e.g., why the therapy was taken or administered).x     
INVIDInvestigator IdentifierC83078A sequence of characters used to uniquely identify the study investigator.An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID.     x
INVNAMInvestigator NameC83302The name of the study investigator.Name of the investigator for a site.     x
--LATLateralityC25185ON HOLDQualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, BILATERALxxx   
--LEADLead Identified to Collect MeasurementsC50282An electrical recording from some region of the body that represents the voltage difference between 2 electrodes.Lead or leads identified to capture the measurement for a test from an instrument. Examples: LEAD I, LEAD V2, LEAD CM5.  x   
--LLOQLower Limit of QuantitationC82589

The lowest threshold for reliably quantifying the result of a specific test in standardized units. SDSVAR-111 - Getting issue details... STATUS

Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU.  x   
--LLTLowest Level TermC71886The lowest-level term assigned to the event from MedDRA.MedDRA Lowest Level Term. x    
--LLTCDLowest Level Term CodeC117048The lowest-level term code assigned to the event from MedDRA.MedDRA Lowest Level Term code. x    
--LNKGRPLink Group IDC117049A sequence of characters used to uniquely identify a group of records in one domain and link it to 1 or more records in another domain.Identifier used to link related records across domains. This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record.   x  
--LNKIDLink IDC117050A sequence of characters used to uniquely identify a record in one domain and link it to 1 or more records in another domain.Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit.   x  
--LOCLocation Used for the MeasurementC25341ON HOLDAnatomical location of the subject relevant to the collection of the measurement. Examples: RECTAL for temperature, ARM for blood pressure.xxx   
--LOINCLOINC CodeC82502A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database.Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.  x   
--LOTLot NumberC70848An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.Lot number for the intervention described in --TRT.x     
--METHODMethod of Test or ExaminationC82535ON HOLDMethod of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK  x   
--MODIFYModified TermC25446A value which represents an alteration to a collected value for coding purposes.If the value of --ORRES is modified for coding purposes, then the modified text is placed here.xxx   
--MOODMood VDT-71 - Getting issue details... STATUS C117051The state that may be applied to a record to indicate its phase in a life cycle or business process (e.g., scheduled, performed).Mode or condition of the record (e.g., SCHEDULED, PERFORMED).x     
--NAMLaboratory/Vendor NameC117200The name of the vendor performing an assessment.Name or identifier of the vendor (e.g., laboratory) that provided the test results.  x   
--NOMDYNominal Study Day for TabulationsCNEWThe nominal study day, relative to the sponsor-defined reference start date, used by data-collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (e.g., for output on a tabulation report).The nominal study day used by data-collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (such as for output on a tabulation report). Not to be used with human clinical trials.    x 
--NOMLBLLabel for Nominal Study DayCNEWThe name for a protocol-defined nominal study day.A label for a given value of --NOMDY, within a domain, as presented in the study report. Not to be used with human clinical trials.    x 
--NRINDNormal/Reference Range IndicatorC82532A classification of the original or standardized result as it relates to a normal or reference result range.Used to indicate the value is outside the normal range or reference range. May be defined by --ORNRLO and --ORNRHI or other objective criteria. Examples: Y, N; HIGH, LOW; NORMAL; ABNORMAL.  x   
--OCCUROccurrenceC25275An indication as to whether a prespecified event or intervention has occurred.Used to record whether a pre-specified intervention occurred when information about the occurrence of a specific intervention is solicited.xx    
--ORNRHINormal Range Upper Limit-Original UnitsC70933The highest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.Upper end of normal range or reference range for results stored in --ORRES.  x   
--ORNRLONormal Range Lower Limit-Original UnitsC82580The lowest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.Lower end of normal range or reference range for results stored in --ORRES.  x   
--ORRESResult or Finding in Original UnitsC117221The result of the measurement, test, or examination, as originally received or collected.Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS.  x   
--ORRESUOriginal UnitsC82586The unit of measure for the result (as originally received or collected) of the measurement, test, or examination.Unit for --ORRES. Examples: IN, LB, kg/L.  x   
--OUTOutcome of EventC20200The status associated with the result or conclusion of the event.Description of the outcome of an event. Examples: RECOVERED/RESOLVED, FATAL.
x 


--PARTYAccountable PartyC117052The role of the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen).Party accountable for the transferable object (e.g. device, specimen) as a result of the activity performed in the associated --TERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the --PRTYID variable. x    
--PATTPattern of EventC82550A characterization of the temporal pattern of occurrences of the event.Used to indicate the pattern of the event over time. Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT. x    
POOLIDPool IdentifierC117053A sequence of characters used to uniquely identify a group of subjects that have been pooled together.An identifier used to identify a result from a group of subjects that is not assignable to a specific subject.   x  
--PORTOTPortion or TotalityC103166ON HOLDQualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. . Examples: ENTIRE, SINGLE, SEGMENT, MANY.xxx   
--POSPosition of Subject During ObservationC62164The particular way that a subject's body is placed or situated during an assessment.Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING.  x   
--PRESPPre-specifiedC82510An indication that the event or intervention was prospectively stated or detailed on the CRF.Used when a specific intervention is pre-specified on a CRF. Values should be “Y” or null.xx    
--PRTYIDIdentification of Accountable PartyC117054A sequence of characters used to uniquely identify the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen).Identification of the specific party accountable for the transferable object (e.g. device, specimen) after the action in --TERM is taken. Used in conjunction with --PARTY. x    
--PSTRGPharmaceutical StrengthC53294The amount of active ingredient per unit of pharmaceutical dosage form.Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. Example: 50 mg/TABLET, 300 mg/Lx     
--PSTRGUPharmaceutical Strength UnitsC117055The unit of measure for the amount of active ingredient per unit of pharmaceutical dosage form, using standardized values.Unit for --PSTRG. Example: mg/TABLET, mg/mLx     
--PTCDPreferred Term CodeC117056The preferred term code assigned to the event from MedDRA.MedDRA Preferred Term code. x    
RACERaceC17049ON HOLDRace of the subject. Sponsors should refer to “Collection of Race and Ethnicity Data in Clinical Trials” (FDA, September 2005) for guidance regarding the collection of race (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) See Assumption below regarding RACE.     x
RACEOTHRace OtherC104495ON HOLDA free-text field to be used when none of the preprinted values for RACE are applicable or if another, unprinted selection should be added to those preprinted values. (CDASH only)     x
--REASEXReason for Exclusion from StatisticsC117057The explanation for why a result is excluded from all calculations.Reason excluded from statistics. Used in conjunction with --EXCLFL when its value is Y. Not to be used with human clinical trials.  x   
--REASNDReason Not DoneC82556The explanation for why requested information was not available.Reason not done. Used in conjunction with --STAT when value is NOT DONE.xxx   
--REFIDReference IDC82531A sequence of characters used to uniquely identify a source of information.Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.   x  
--RELCausalityC82552The investigator's assessment of the likelihood that the study treatment was the cause of the event.Records the investigator's opinion as to the causality of the event to the treatment. ICH E2A and E2B examples include NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED. x    
--RELNSTRelationship to Non-Study TreatmentC82564The investigator's assessment of the causal relationship of the event to a non-study treatment.An opinion as to whether the event may have been due to a treatment other than study drug. Example: "MORE LIKELY RELATED TO ASPIRIN USE." x    
--RESCATResult CategoryC82498A grouping or classification of the results of an assessment.Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.  x   
RESLOCResult Location of FindingCNEWAnatomical 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. Not to be used with human clinical trials.  x   
RFENDTCSubject Reference End Date/TimeC83394The end date or date and time of the sponsor-defined study reference period, represented in a standardized character format.Reference End Date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the trial, and often equivalent to date/time of last exposure to study treatment. Required for all randomized subjects; null for screen failures or unassigned subjects.     x
RFICDTCDate/Time of Informed ConsentC117452The date or date and time of informed consent, represented in a standardized character format.Date/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent.     x
RFPENDTCDate/Time of End of ParticipationC117453The date or date and time of last contact with or information about a subject in a trial, represented in a standardized character format.Date/time when subject ended participation or follow-up in a trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples: completion date, withdrawal date, last follow-up, date recorded for lost to follow up, or death date.     x
RFSTDTCSubject Reference Start Date/TimeC83395The start date or date and time of the sponsor-defined study reference period, represented in a standardized character format.Reference Start Date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. Required for all randomized subjects; will be null for all subjects who did not meet the milestone the date requires, such as screen failures or unassigned subjects.     x
--RFTDTCDate/Time of Reference Time PointC82518The actual date or date and time of a time point that acts as a fixed reference for a series of planned time points, represented in a standardized character format.Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 character format.    x 
RFXENDTCDate/Time of Last Study TreatmentC117454The end date or date and time of the last exposure to any protocol-specified treatment or therapy, represented in a standardized character format.Last date of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing).     x
RFXSTDTCDate/Time of First Study TreatmentC117455The start date or date and time of the first exposure to any protocol-specified treatment or therapy, represented in a standardized character format.First date of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC.     x
--ROUTERoute of AdministrationC38114Designation of the part of the body through which or into which, or the way in which, a substance is introduced.Route of administration for the intervention. Examples: ORAL, INTRAVENOUS.x     
--RPATHDescription of Planned Repro PathCNEWThe name of the planned reproductive path to which the subject was assigned.Name of the planned Repro Path.     x
--RPATHCDPlanned Repro Path CodeCNEWA short sequence of characters that represents the planned reproductive path to which the subject was assigned.Short name for the planned Repro Path to which the subject was assigned. Limited to 20 characters. Not to be used with human clinical trials.     x
--RPDYActual Repro Phase Day of ObservationCNEWThe day within the reproductive phase on which the test or observation occurred.The actual day within the Reproductive Phase on which the observation occurred. Expressed as an integer. Not to be used with human clinical trials.    x 
--RPENDYActual Repro Phase Day of Obs EndCNEWThe day within the reproductive phase on which the test or observation ended.The actual day within the Reproductive Phase of the end of the observation. Expressed as an integer. Not to be used with human clinical trials.    x 
RPPLDYPlanned Repro Phase Day of ObservationCNEWThe day within the reproductive phase on which the test or observation was scheduled to occur.The planned day within the Reproductive Phase on which the observation was scheduled to occur. Expressed as an integer. Not to be used with human clinical trials.    x 
RPPLENDYPlanned Repro Phase Day of Obs EndCNEWThe day within the reproductive phase on which the test or observation was scheduled to end.The planned day within the Reproductive Phase of the end of the observation. Expressed as an integer. Not to be used with human clinical trials.    x 
RPPLSTDYPlanned Repro Phase Day of Obs StartCNEWThe day within the reproductive phase on which the test or observation was scheduled to begin.The planned day within the Reproductive Phase of the start of the observation. Expressed as an integer. Not to be used with human clinical trials.    x 
--RPSTDYActual Repro Phase Day of Obs StartCNEWThe day within the reproductive phase on which the test or observation began.The actual day within the Reproductive Phase of the start of the observation. Expressed as an integer. Not to be used with human clinical trials.    x 
--RUNIDRun IDC117058A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples.A unique identifier for a particular run of a test on a particular batch of samples.  x   
SBSTRAINStrain/Substrain DetailsC117456Additional clarifying details regarding the test system under study, such as a description of a phenotypic alteration associated with the specific genetic modification captured or collected in the Strain/Substrain variable.Free-text field that allows the sponsor to enter additional details regarding the subject (i.e., test system) under study, such as a description of a specific genetic alteration.     x
--SCANInvolves CancerC82561An indication as to whether the reason an event was serious was because the event was associated with cancer.Was the event associated with the development of cancer? Valid values are “Y” and “N”. x    
--SCATSubcategoryC25692A further grouping or classification of the category for the topic of the finding, event, or intervention.Used to define a further categorization of --CAT values. Example: DIFFERENTIAL.xxx   
--SCONGCongenital Anomaly or Birth DefectC2849An indication as to whether the reason an event is serious is because the event is associated with congenital anomaly or birth defect in an offspring of the subject.Was the event associated with congenital anomaly or birth defect? Valid values are “Y” and “N”. x    
--SDISABPersist or Signif Disability/IncapacityC68606An indication as to whether the reason an event is serious is because the event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the subject's body function/structure, physical activities, and/or quality of life.Did the event result in persistent or significant disability/incapacity? Valid values are “Y” and “N”. x    
--SDTH VDT-72 - Getting issue details... STATUS Results in DeathC82549An indication as to whether the reason an event is serious is because the event resulted in death.Did the event result in death? Valid values are “Y” and “N”. x    
--SEQSequence NumberC70710A number used to uniquely identify records for a subject within a domain.Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.   x  
--SERSerious EventC82578A collected indication as to whether an event meets regulatory criteria for seriousness.Is this is a serious event? Valid values are “Y” and “N”. x    
SETCDSet CodeC117457The standardized or dictionary-derived short sequence of characters used to represent the trial set.Short name of a specific Trial Set (see Table 3.2.4), as defined by the sponsor. Maximum of 8 characters. This represents the code for the Trial Set for which parameters are being submitted.     x
--SEVSeverityC25676The quality or degree of harm associated with a finding or event, as collected.Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. xx   
SEXSexC28421ON HOLDSex of the subject.     x
--SHOSPRequires or Prolongs HospitalizationC68605An indication as to whether the reason an event is serious is because the event resulted in or prolonged hospitalization.Did the event require or prolong hospitalization? Valid values are “Y” and “N”. x    
SITEIDStudy Site IdentifierC83081A sequence of characters used to uniquely identify the facility associated with study-specific activities.Unique identifier for a site within a study.     x
--SLIFEIs Life ThreateningC82508An indication as to whether the reason an event is serious is because the event resulted in a substantial risk of dying.Was the event life threatening? Valid values are “Y” and “N”. x    
--SMIEOther Medically Important Serious EventC82521An indication as to whether the reason an event is serious is because the event may jeopardize the subject and may require intervention to prevent one of the other outcomes associated with serious adverse events.Do additional categories for seriousness apply? Valid values are “Y” and “N”. x    
--SOCPrimary System Organ ClassC71888The system organ class from the primary hierarchy assigned in the MedDRA dictionary.MedDRA primary System Organ Class associated with the event. x    
--SOCCDPrimary System Organ Class CodeC117059The system organ class code from the primary hierarchy assigned in the MedDRA dictionary.MedDRA primary System Organ Class code. x    
--SODOccurred with OverdoseC82548An indication as to whether the reason an event is serious is because the event is associated with overdose.Did the event occur with an overdose? Valid values are “Y” and “N”. x    
--SPCCNDSpecimen ConditionC70714The physical state or quality of a sample for assessment.Defines the condition of the specimen. Example: CLOUDY.  x   
--SPCUFLSpecimen Usability for the TestC105758An indication as to whether a sample is suitable for testing.Describes the usability of the specimen for the test. The value will be N if the specimen is not usable, and null if the specimen is usable.  x   
SPDEVIDSponsor Device IdentifierC117060A sequence of characters used by the sponsor to uniquely identify a specific device.Sponsor-defined identifier for a device   x  
--SPECSpecimen Material TypeC70713The type of sample material taken from a biological entity.Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA.  x   
SPECIESSpeciesC45293The common (non-taxonomic) name for an animal used as the test system in a study.Used to identify the common species name of the subject (i.e., test system) under study. Examples: MOUSE, RAT, DOG, MONKEY.     x
--SPIDSponsor-Defined IdentifierC82530A sponsor-defined sequence of characters used to identify an instance of an observation.Sponsor-defined identifier. Example: preprinted line identifier on a Concomitant Medications page.   x  
--STATCompletion StatusC41202ON HOLDUsed to indicate that a question was not asked or a test was not done, or that a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.xxx   
--STDTCStart Date/Time of ObservationC82517The start date or date and time of an intervention or event, represented in a standardized character format.Start date/time of an observation represented in IS0 8601 character format.    x 
--STDYStudy Day of Start of ObservationC82570The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation.Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.    x 
--STINTPlanned Start of Assessment IntervalC117061The start of a planned assessment interval relative to a reference time point, represented in a standardized character format.The start of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).    x 
--STNRCNormal Range for Character ResultsC78727A set of normal or reference values for the standardized character result, in an ordinal scale or categorical grouping.Normal range or reference range for results stored in --STRESC that are character in ordinal or categorical scale. Example: Negative to Trace.  x   
--STNRHINormal Range Upper Limit-Standard UnitsC25706The highest value in a normal or reference range for the standardized result of the measurement, test, or examination.Upper end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU).  x   
--STNRLONormal Range Lower Limit-Standard UnitsC25555The lowest value in a normal or reference range for the standardized result of the measurement, test, or examination.Lower end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU).  x   
STRAINStrain/SubstrainC14419The vendor-supplied species/strain/substrain designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g. FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS and CHIMPANZEE).Used to identify the vendor-supplied strain/substrain designation for the subject (i.e., test system) under study. When applicable, it combines the root strain, substrain, and associated genetic modifications, as supplied by the vendor. Examples: C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, CHIMPANZEE.     x
--STRESCResult or Finding in Standard FormatC117222The standardized result of the measurement, test, or examination in character format.Contains the result value for all findings, copied or derived from --ORRES in a standard format or in standard units. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. For example, if various tests have results “NONE”, “NEG”, and “NEGATIVE” in --ORRES and these results effectively have the same meaning, they could be represented in standard format in --STRESC as "NEGATIVE".  x   
--STRESNNumeric Result/Finding in Standard UnitsC70952The standardized result of the measurement, test, or examination in numeric format.Used for continuous or numeric results or findings in standard format; copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.  x   
--STRESUStandard UnitsC82587The unit of measure for the standardized result of the measurement, test, or examination.Standardized units used for --STRESC and --STRESN. Example: mol/L.  x   
--STRFStart Relative to Reference PeriodC82559The characterization of the start of an observation relative to the study reference period.

Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.

Note: This variable will be deprecated (phased out) in a future (post-SDTM v1.4) release. The functionality of this variable can be replaced by the use of --STRTPT with --STTPT = RFSTDTC.

    x 
--STRTPTStart Relative to Reference Time PointC82560The characterization of the start of an observation relative to a reference time point.Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT.    x 
--STTPTStart Reference Time PointC82575The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation.Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15", "VISIT 1".    x 
STUDYIDStudy IdentifierC83082A sequence of characters used by the sponsor to uniquely identify the study.Unique identifier for a study.   x x
SUBJIDSubject Identifier for the StudyC83083A sequence of characters used to uniquely identify a subject within a study.Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.     x
TAETORDPlanned Order of Element within ArmC83438An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.Number that gives the planned order of the Element within the Arm (see Trial Arms, Section 3.2.2 ).    x 
--TERMReported TermC82571The collected name for an event observation.Topic variable for an event observation, which is the verbatim or pre-specified name of the event. x    
--TESTName of Measurement, Test or ExaminationC82541The standardized or dictionary-derived name of the measurement, test, or examination.Long name For --TESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination.  x   
--TESTCDShort Name of Measurement, Test or ExaminationC82503The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination.Short character value for --TEST 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. Examples: PLAT, SYSBP, RRMIN, EYEEXAM.  x   
--TOXToxicityC27990The standardized or dictionary-derived name for an untoward event or finding.Description of toxicity quantified by --TOXGR, such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. xx   
--TOXGRToxicity GradeC82528A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation.Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define data definition document. Example: 2. xx   
--TPTPlanned Time Point NameC82539The description of the time when a protocol-defined activity is planned to occur, used for study data tabulation.Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See --TPTNUM and --TPTREF.    x 
--TPTNUMPlanned Time Point NumberC82545The numeric identifier of when an observation is planned to occur.Numeric version of planned time point used in sorting.    x 
--TPTREFTime Point ReferenceC82576The description of a time point that acts as a fixed reference for a series of planned time points, used for study data tabulation.Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.    x 
--TRTName of TreatmentC82542The reported name of the drug, procedure, or therapy.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.x     
--TRTVTreatment VehicleC927A carrier or inert medium in which a medicinally active agent is administered.Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.x     
--TSTDTLMeasurement, Test or Examination DetailC117062ON HOLDFurther description of --TESTCD and --TEST. Example: “The percentage of cells with +1 intensity of staining” when MITESTCD=TTF1.  x   
--ULOQUpper Limit of QuantitationC85533The highest threshold for reliably detecting the result of a specific test in standardized units.Indicates the upper limit of quantitation for an assay. Units will be those used for --STRESU.  x   
USCHFL VDT-70 - Getting issue details... STATUS Unscheduled FlagCNEWAn indication that the performed test or observation was done at a time that was not preplanned.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. Not to be used with human clinical trials. 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.  x   
USUBJIDUnique Subject IdentifierC70731A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.   x x
--VAMTTreatment Vehicle AmountC82553Amount of the prepared product (treatment plus vehicle) administered.Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.x     
--VAMTUTreatment Vehicle Amount UnitsC82583The unit of measure for the prepared product (treatment plus vehicle) using standardized values.Units for the prepared product (treatment + vehicle). Examples: mL, mg.x     
VISITVisit NameC83093The label for a protocol-defined clinical encounter (e.g., 06 Sep 2018).Protocol-defined description of a clinical encounter.    x 
VISITDYPlanned Study Day of VisitC83450The planned study day of a clinical encounter relative to the sponsor-defined reference start date.Planned study day of VISIT. Should be an integer.    x 
VISITNUMVisit NumberC83101An assigned numeric identifier that aligns to the chronological order of a clinical encounter.Clinical encounter number. Numeric version of VISIT, used for sorting.    x 
--XFNExternal File PathC82536The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study.Filename for an external file, such as one for an ECG waveform or a medical image.  x   
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