• Background on CDISC SDTM Standards
• Advantages of SDTM
• Latest CDISC SDTM Standards and Implementation Guides
• Demonstrate SDTM Mapping
• SDTM Compliance

The CDISC standard domain models (SDTMIG 3.2)

Special-Purpose Domains:

• Comments (CO)
• Demographics (DM)
• Subject Elements (SE)
• Subject Visits (SV)

Interventions General Observation Class:

• Concomitant Medications (CM)
• Exposure as Collected (EC)
• Exposure (EX)
• Substance Use (SU)
• Procedures (PR)

Events General Observation Class:

• Adverse Events (AE)
• Clinical Events (CE)
• Disposition (DS)
• Protocol Deviations (DV)
• Medical History (MH)
• Healthcare Encounters (HO)

Findings General Observation Class:

• 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 (RP)
• Disease Response (RS)
• Subject Characteristics (SC)
• Subject Status (SS)
• Tumor Identification (TU)
• Tumor Results (TR)
• Vital Signs (VS)

Findings About :

• Findings About Events or Interventions (FA)
• Skin Response (SR)

Trial Design Domains:

• Trial Arms (TA)
• Trial Disease Assessment (TD)
• Trial Elements (TE)
• Trial Visits (TV)
• Trial Inclusion/Exclusion Criteria (TI)
• Trial Summary (TS)

Special-Purpose Relationship Datasets:

• Qualifiers - SUPPQUAL
• Relate Records - RELREC