SDTM - The CDISC Standard Domain Models (SDTMIG 3.1.2 and SENDIG 3.0)

The CDISC Standard Domain Models (SDTMIG 3.1.2 and SENDIG 3.0)

Special-Purpose Domains:

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

Interventions:

  • Concomitant Medications - CM (SDTMIG only)
  • Exposure - EX
  • Substance Use - SU (SDTMIG only)

Events:

  • Adverse Events - AE (SDTMIG only)
  • Disposition - DS
  • Medical History - MH (SDTMIG only)
  • Protocol Deviations - DV (SDTMIG only)
  • Clinical Events - CE (SDTMIG only)

Findings:

  • Body Weight - BW (SEND only)
  • Body Weight Gain - BG (SEND only)
  • Clinical Observations - CL (SEND only)
  • Death Diagnosis - DD (SEND only)
  • Drug Accountability - DA (SDTMIG only)
  • ECG Tests - EG
  • Findings About Events or Interventions - FA (SDTMIG only)
  • Food and Water Consumption - FW (SEND only)
  • Inclusion/Exclusion Exceptions - IE (SDTMIG only)
  • Laboratory Tests - LB
  • Macroscopic Findings - MA (SEND only)
  • Microbiology Specimens - MB (SDTMIG only)
  • Microbiology Susceptibility - MS (SDTMIG only)
  • Microscopic Findings - MI (SEND only)
  • Organ Measurements - OM (SEND only)
  • Palpable Masses - PA (SEND only)
  • Pharmacokinetics Concentrations - PC
  • Pharmacokinetics Parameters - PP
  • Physical Examinations - PE (SDTMIG only)
  • Questionnaires - QS (SDTMIG only)
  • Subject Characteristics - SC
  • Tumor Findings - TF (SEND only)
  • Vital Signs - VS

Trial Design Domains:

  • Trial Elements - TE
  • Trial Arms - TA
  • Trial Visits - TV (SDTMIG only)
  • Trial Inclusion/Exclusion Criteria – TI (SDTMIG only)
  • Trial Summary - TS

Special-Purpose Relationship Datasets:

  • Supplemental Qualifiers - SUPPQUAL
  • Relate Records - RELREC
  • Pooled Definition - POOLDEF (SEND only)

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