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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Statistical Procedures for Clinical Trials | 15% | - Descriptive statistics - Generate analysis outputs - PROC TTEST, FREQ, MEANS, UNIVARIATE |
| Topic 2: Clinical Trials Data Structures | 10% | - Types of clinical trial datasets - Annotated CRF and define.xml - CDISC standards: SDTM, ADaM |
| Topic 3: Manage Clinical Trials Data | 5% | - Import/export data files - Data cleaning and manipulation - Handle missing data |
| Topic 4: Macro Programming for Clinical Trials | 15% | - Write reusable macro programs - Create and use macro variables - Debug macro logic |
| Topic 5: Clinical Trials Process | 5% | - Regulatory requirements: GCP, ICH, 21 CFR Part 11 - Clinical research phases and key roles - Interpret Statistical Analysis Plan (SAP) |
| Topic 6: Report Clinical Trials Results | 10% | - Format outputs for regulatory submission - PROC REPORT, TABULATE, PRINT - ODS statements for TLFs |
| Topic 7: Transform or Summarize Clinical Trials Data | 15% | - Derive analysis variables - Apply LOCF/BOCF techniques - Subset, merge, and restructure datasets |
| Topic 8: Validate Clinical Trial Data Reporting | 25% | - Review SAS log for errors/warnings - Verify consistency of tables/listings/figures - Use PROC COMPARE for validation |
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