Analysis Data Subject Level (ADSL) Generation with SAS
ADaM, ADSL, CDISC, SAS, clinical trials, biostatistics, regulatory
Analysis Data Subject Level (ADSL) Generation with SAS
Automated creation of ADSL dataset for clinical trials analysis using ADaM standards and multi-domain SDTM integration.
Introduction
The Analysis Data Subject Level (ADSL) dataset is the cornerstone of clinical trial statistical analysis under the CDISC Analysis Data Model (ADaM) standard. ADSL provides one record per subject containing all subject-level information needed for efficacy and safety analyses.
What is ADaM ADSL?
ADSL serves as the foundation dataset that:
Contains one record per subject with subject-level analysis variables
Defines analysis populations (Safety, ITT, Per-Protocol)
Provides treatment information and study periods
Links to all other ADaM datasets through USUBJID
Ensures consistency across all statistical analyses
Regulatory Importance
FDA Requirement: Essential for regulatory submissions
Analysis Foundation: Referenced by all BDS and OCCDS datasets
Population Definition: Critical for primary endpoint analyses
Traceability: Links analysis results back to SDTM source