Module 12 Presentations

26/01/2024

SDTM Background Provides means to submit clinical tabulation data to the FDA in a standard format. Defines specific rules: – Domain/variable names – Structures – Consistency – Controlled Terminology Facilitates: – Review of submissions using standard tools – Population of cross-trial database (Janus model)

Science & Regulation determine content

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SDTM Classifications

Interventio ns • CM - Medications • EX - Exposure • SU - Substance use

Special Purpose

Events

Findings

• AE -Adverse Events • MH - Medical History • DS - Protocol Milestones

• PE - Physical Exam • LB - Lab • TR - Tumor Response

• DM –

Demography • SV - Subject Visits

The Organisation for Professionals in Regulatory Affairs

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