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Clinical Trials Programming Using SAS 9 Accelerated Version (A00-281) Exam Reference
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What is Clinical Trials Programming Using SAS 9 Accelerated Version (A00-281) Exam
This exam validates the candidate's ability for the clinical trial process, access, management and transformation of clinical trial data, statistical procedures and macroprogramming, communication of clinical trial results and validation. clinical trial data reports.
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SASInstitute A00-281 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Statistical Procedures for Clinical Trials | 15% | - Generate analysis outputs - PROC TTEST, FREQ, MEANS, UNIVARIATE - Descriptive statistics |
| Macro Programming for Clinical Trials | 15% | - Write reusable macro programs - Create and use macro variables - Debug macro logic |
| Transform or Summarize Clinical Trials Data | 15% | - Subset, merge, and restructure datasets - Derive analysis variables - Apply LOCF/BOCF techniques |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Annotated CRF and define.xml - Types of clinical trial datasets |
| Clinical Trials Process | 5% | - Regulatory requirements: GCP, ICH, 21 CFR Part 11 - Clinical research phases and key roles - Interpret Statistical Analysis Plan (SAP) |
| Validate Clinical Trial Data Reporting | 25% | - Verify consistency of tables/listings/figures - Review SAS log for errors/warnings - Use PROC COMPARE for validation |
| Manage Clinical Trials Data | 5% | - Import/export data files - Handle missing data - Data cleaning and manipulation |
| Report Clinical Trials Results | 10% | - ODS statements for TLFs - Format outputs for regulatory submission - PROC REPORT, TABULATE, PRINT |
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