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