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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Macro Programming for Clinical Trials | 15% | - Automate clinical programming tasks - Create and use SAS macros |
| Topic 2: Report Clinical Trials Results | 10% | - Create clinical trial reports - Produce tables, listings, and reports |
| Topic 3: Transform or Summarize Clinical Trials Data | 15% | - Use SAS DATA step programming techniques - Create derived datasets and variables |
| Topic 4: Clinical Trials Programming Concepts | - Clinical trial programming standards and practices - CDISC standards and clinical data structures | |
| Topic 5: Manage Clinical Trials Data | 5% | - Import, access, and manage clinical trial data - Apply clinical data management concepts |
| Topic 6: Regulatory Submissions | 5% | - Prepare data and documentation for regulatory submission |
| Topic 7: Apply Statistical Procedures for Clinical Trials | 15% | - Use SAS statistical procedures - Analyze clinical trial data |
| Topic 8: Validate Clinical Trial Data Reporting | 20% | - Perform quality control programming - Validate clinical trial outputs |
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