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Clinical Trials Process
Clinical Trials Programming Using SAS 9 Accelerated Version (A00-281) Exam Reference
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| Section | Weight | Objectives |
|---|---|---|
| Manage Clinical Trials Data | 5% | - Import/export data files - Handle missing data - Data cleaning and manipulation |
| Statistical Procedures for Clinical Trials | 15% | - Descriptive statistics - Generate analysis outputs - PROC TTEST, FREQ, MEANS, UNIVARIATE |
| Macro Programming for Clinical Trials | 15% | - Debug macro logic - Write reusable macro programs - Create and use macro variables |
| Clinical Trials Data Structures | 10% | - Types of clinical trial datasets - Annotated CRF and define.xml - CDISC standards: SDTM, ADaM |
| Transform or Summarize Clinical Trials Data | 15% | - Derive analysis variables - Subset, merge, and restructure datasets - Apply LOCF/BOCF techniques |
| Report Clinical Trials Results | 10% | - ODS statements for TLFs - PROC REPORT, TABULATE, PRINT - Format outputs for regulatory submission |
| 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% | - Use PROC COMPARE for validation - Review SAS log for errors/warnings - Verify consistency of tables/listings/figures |
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