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SDTM Domains

SDTM organizes clinical trial data into domains based on the type of observation.

Domain Categories

Special Purpose Domains

Core structural domains required for all submissions.

DomainNameDescription
DMDemographicsSubject demographic information
COCommentsFree-text comments
SESubject ElementsSubject milestones
SVSubject VisitsVisits for each subject
TATrial ArmsPlanned study arms
TDTrial DiseaseDisease descriptions
TETrial ElementsPlanned protocol elements
TITrial Inclusion/ExclusionEligibility criteria
TSTrial SummaryStudy-level parameters
TVTrial VisitsPlanned visits

Interventions Domains

Treatments and substances given to or used by subjects.

DomainNameDescription
CMConcomitant MedicationsNon-study medications
ECExposure as CollectedExposure data as collected
EXExposureStudy treatment exposure
PRProceduresNon-study procedures
SUSubstance UseTobacco, alcohol, etc.

Events Domains

Discrete occurrences during study participation.

DomainNameDescription
AEAdverse EventsAll adverse events
CEClinical EventsNon-adverse clinical events
DSDispositionSubject status at milestones
DVProtocol DeviationsProtocol violations
HOHealthcare EncountersHospitalizations, ER visits
MHMedical HistoryPrior conditions

Findings Domains

Observations and measurements.

DomainNameDescription
DADrug AccountabilityDrug dispensing/return
DDDeath DetailsCause of death details
EGECG ResultsElectrocardiogram data
FTFunctional TestsFunctional assessments
IEInclusion/ExclusionSubject eligibility
ISImmunogenicity SpecimenSample assessments
LBLab ResultsLaboratory tests
MBMicrobiology SpecimenMicrobiology samples
MIMicroscopic FindingsHistopathology
MKMusculoskeletalMusculoskeletal findings
MOMorphologyImaging morphology
MSMicrobiology SusceptibilityAntibiotic susceptibility
NVNervous SystemNeurological findings
OEOphthalmologyEye exam results
PCPharmacokinetics ConcentrationsDrug concentrations
PEPhysical ExamPhysical examination
PPPK ParametersPharmacokinetic parameters
QSQuestionnairesPRO/questionnaire data
RERespiratoryPulmonary function
RPReproductiveReproductive findings
RSDisease ResponseTumor response
SCSubject CharacteristicsAdditional demographics
SSSubject StatusSubject enrollment status
TRTumor/Lesion ResultsTumor measurements
TUTumor/Lesion IdentificationTumor identification
URUrinary SystemUrological findings
VSVital SignsVital sign measurements

Common Domain Details

DM - Demographics

Required for all studies. Contains one record per subject.

Key Variables:

  • USUBJID (Unique Subject ID)
  • AGE, AGEU (Age and units)
  • SEX, RACE, ETHNIC
  • ARM, ARMCD (Study arm)
  • RFSTDTC, RFENDTC (Reference dates)
  • COUNTRY, SITEID

AE - Adverse Events

Captures all adverse events during the study.

Key Variables:

  • AETERM (Verbatim term)
  • AEDECOD (Dictionary-coded term)
  • AESTDTC, AEENDTC (Start/end dates)
  • AESEV (Severity)
  • AESER (Serious)
  • AEREL (Relationship to treatment)
  • AEOUT (Outcome)

VS - Vital Signs

Captures vital sign measurements.

Key Variables:

  • VSTESTCD, VSTEST (Test code/name)
  • VSORRES, VSSTRESC, VSSTRESN (Results)
  • VSORRESU, VSSTRESU (Units)
  • VSPOS (Position)
  • VSDTC (Date/time)
  • VISITNUM, VISIT

LB - Laboratory Results

Captures laboratory test results.

Key Variables:

  • LBTESTCD, LBTEST (Test code/name)
  • LBORRES, LBSTRESC, LBSTRESN (Results)
  • LBORRESU, LBSTRESU (Units)
  • LBSPEC (Specimen type)
  • LBDTC (Date/time)
  • LBNRIND (Reference range indicator)

Custom Domains

For data not fitting standard domains, create custom domains:

  • Two-letter code starting with X, Y, or Z
  • Follow general observation class rules
  • Document in Define-XML

Next Steps