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2 Fundamentals of the SDTM
2.1 Observations and Variables

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2.5 The SDTM Standard Domain Models

The following standard domains, listed in alphabetical order by Domain Code, with their respective domain codes
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Special-Purpose Domains (defined in Section 5 Models For Special-Purpose Domains):
Comments (CO) Demographics (DM)
Subject Elements (SE) Subject Visits (SV)
Interventions General Observation Class (defined in Section 6.1 - Interventions):
Concomitant Medications (CM) Exposure as Collected (EC)
Exposure (EX) Substance Use (SU)
Procedures (PR)
Events General Observation Class (defined in Section 6.2 - Events):
Adverse Events (AE) Clinical Events (CE)
Disposition (DS) Protocol Deviations (DV)
Healthcare Encounters (HO) Medical History (MH)
Findings General Observation Class (defined in Section 6.3 - Findings):
Drug Accountability (DA) Death Details (DD)
ECG Test Results (EG) Inclusion/Exclusion Criterion Not Met (IE)
Immunogenicity Specimen
Assessments (IS)
Laboratory Test Results (LB)
Microbiology Specimen (MB) Microscopic Findings (MI)
Morphology (MO) Microbiology Susceptibility Test (MS)
PK Concentrations (PC) PK Parameters (PP)
Physical Examination (PE) Questionnaires (QS)
Reproductive System Findings
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Disease Response (RS)
Subject Characteristics (SC) Subject Status (SS)
Tumor Identification (TU) Tumor Results (TR)
Vital Signs (VS)
Findings About (defined in Section 6.4 - FA Domain)
Findings About (FA) Skin Response (SR)
Trial Design Domains (defined in Section 7 - Trial Design Datasets):
Trial Arms (TA) Trial Disease Assessment (TD)
Trial Elements (TE) Trial Visits (TV)
Trial Inclusion/Exclusion Criteria
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Trial Summary (TS)
Relationship Datasets (defined in Section 8 - Representing Relationships and Data):
Supplemental Qualifiers (SUPP-- datasets) Related Records (RELREC)

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3.1 Standard Metadata for Dataset Contents and Attributes

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