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SASInstitute A00-281 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Manage Clinical Trials Data | 5% | - Handle missing data - Data cleaning and manipulation - Import/export data files |
| Transform or Summarize Clinical Trials Data | 15% | - Derive analysis variables - Subset, merge, and restructure datasets - Apply LOCF/BOCF techniques |
| Clinical Trials Process | 5% | - Interpret Statistical Analysis Plan (SAP) - Clinical research phases and key roles - Regulatory requirements: GCP, ICH, 21 CFR Part 11 |
| Report Clinical Trials Results | 10% | - ODS statements for TLFs - PROC REPORT, TABULATE, PRINT - Format outputs for regulatory submission |
| Clinical Trials Data Structures | 10% | - Types of clinical trial datasets - Annotated CRF and define.xml - CDISC standards: SDTM, ADaM |
| Statistical Procedures for Clinical Trials | 15% | - PROC TTEST, FREQ, MEANS, UNIVARIATE - Generate analysis outputs - Descriptive statistics |
| Validate Clinical Trial Data Reporting | 25% | - Use PROC COMPARE for validation - Verify consistency of tables/listings/figures - Review SAS log for errors/warnings |
| Macro Programming for Clinical Trials | 15% | - Create and use macro variables - Debug macro logic - Write reusable macro programs |
