ADaM ADSL (Subject-Level Analysis Dataset)

Core subject-level ADaM dataset built from SDTM to define one record per subject, capturing treatment variables, key study dates, baseline covariates, and analysis population flags (e.g., ITT/SAF/PP) that anchor downstream analyses.

Deliverables

Specifications

• ADSL Specifications

Programming

• Build ADSL (R Derivation Program)

What you’ll find here

• Purpose: One record per subject (analysis-ready subject backbone)
• Traceability: Spec → Program → Output alignment
• Typical variables: STUDYID, USUBJID, SITEID, AGE, SEX, RACE, TRT01P, TRT01A, TRTSDT, TRTEDT, RFSTDTC, and population flags like ITTFL, SAFFL, PPROTFL