Version Domain Examples Label Structure Class
33 CO 1 Examples Comments One record per comment per subject Special Purpose
33 DM 13 Examples Demographics One record per subject Special Purpose
33 SE 6 Examples Subject Elements One record per actual Element per subject Special Purpose
33 SM 1 Examples Subject Disease Milestones One record per Disease Milestone per subject Special Purpose
33 SV 1 Examples Subject Visits One record per subject per actual visit Special Purpose
33 AG 3 Examples Procedure Agents One record per recorded intervention occurrence per subject Interventions
33 CM 5 Examples Concomitant/Prior Medications One record per recorded intervention occurrence or constant-dosing interval per subject Interventions
33 EC 9 Examples Exposure as Collected One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood Interventions
33 EX 10 Examples Exposure One record per protocol-specified study treatment, constant-dosing interval, per subject Interventions
33 ML 2 Examples Meal Data One record per food product occurrence or constant intake interval per subject Interventions
33 PR 5 Examples Procedures One record per recorded procedure per occurrence per subject Interventions
33 SU 1 Examples Substance Use One record per substance type per reported occurrence per subject Interventions
33 AE 10 Examples Adverse Events One record per adverse event per subject Events
33 CE 6 Examples Clinical Events One record per event per subject Events
33 DS 12 Examples Disposition One record per disposition status or protocol milestone per subject Events
33 DV 1 Examples Protocol Deviations One record per protocol deviation per subject Events
33 HO 4 Examples Healthcare Encounters One record per healthcare encounter per subject Events
33 MH 5 Examples Medical History One record per medical history event per subject Events
33 CV 2 Examples Cardiovascular System Findings One record per finding or result per time point per visit per subject Findings
33 DA 2 Examples Drug Accountability One record per drug accountability finding per subject Findings
33 DD 1 Examples Death Details One record per finding per subject Findings
33 EG 5 Examples ECG Test Results One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject Findings
33 FA 9 Examples Findings About Events or Interventions One record per finding, per object, per time point, per visit per subject Findings
33 FT 1 Examples Functional Tests One record per Functional Test finding per time point per visit per subject Findings
33 IE 1 Examples Inclusion/Exclusion Criteria Not Met One record per inclusion/exclusion criterion not met per subject Findings
33 IS 2 Examples Immunogenicity Specimen Assessments One record per test per visit per subject Findings
33 LB 4 Examples Laboratory Test Results One record per lab test per time point per visit per subject Findings
33 MB 7 Examples Microbiology Specimen One record per microbiology specimen finding per time point per visit per subject Findings
33 MI 5 Examples Microscopic Findings One record per finding per specimen per subject Findings
33 MK 2 Examples Musculoskeletal System Findings One record per assessment per visit per subject Findings
33 MO 3 Examples Morphology One record per Morphology finding per location per time point per visit per subject Findings
33 MS 4 Examples Microbiology Susceptibility One record per microbiology susceptibility test (or other organism-related finding) per organism found in MB Findings
33 NV 4 Examples Nervous System Findings One record per finding per location per time point per visit per subject Findings
33 OE 8 Examples Ophthalmic Examinations One record per ophthalmic finding per method per location, per time point per visit per subject Findings
33 PC 1 Examples Pharmacokinetics Concentrations One record per sample characteristic or time-point concentration per reference time point or per analyte per subject Findings
33 PE 1 Examples Physical Examination One record per body system or abnormality per visit per subject Findings
33 PP 2 Examples Pharmacokinetics Parameters One record per PK parameter per time-concentration profile per modeling method per subject Findings
33 QS 1 Examples Questionnaires One record per questionnaire per question per time point per visit per subject Findings
33 RE 4 Examples Respiratory System Findings One record per finding or result per time point per visit per subject Findings
33 RP 1 Examples Reproductive System Findings One record per finding or result per time point per visit per subject Findings
33 RS 4 Examples Disease Response and Clin Classification One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator Findings
33 SC 1 Examples Subject Characteristics One record per characteristic per subject. Findings
33 SR 5 Examples Skin Response One record per finding, per object, per time point, per visit per subject Findings
33 SS 1 Examples Subject Status One record per finding per visit per subject Findings
33 TR 2 Examples Tumor/Lesion Results One record per tumor measurement/assessment per visit per subject per assessor Findings
33 TU 5 Examples Tumor/Lesion Identification One record per identified tumor per subject per assessor Findings
33 UR 2 Examples Urinary System Findings One record per finding per location per per visit per subject Findings
33 VS 1 Examples Vital Signs One record per vital sign measurement per time point per visit per subject Findings
33 TA 9 Examples Trial Arms One record per planned Element per Arm Trial Design
33 TD 3 Examples Trial Disease Assessments One record per planned constant assessment period Trial Design
33 TE 5 Examples Trial Elements One record per planned Element Trial Design
33 TI 1 Examples Trial Inclusion/Exclusion Criteria One record per I/E crierion Trial Design
33 TM 1 Examples Trial Disease Milestones One record per Disease Milestone type Trial Design
33 TS 2 Examples Trial Summary Information One record per trial summary parameter value Trial Design
33 TV 2 Examples Trial Visits One record per planned Visit per Arm Trial Design
33 RELREC 18 Examples Related Records One record per related record, group of records or dataset Relationships
33 RELSUB Related Subjects One record per relationship per related subject per subject Relationships
33 SUPP-- Supplemental Qualifiers for [domain name] One record per IDVAR, IDVARVAL, and QNAM value per subject Relationships
33 OI Non-host Organism Identifiers One record per taxon per non-host organism Study Reference