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Last Updated: Nov 06, 2026
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| Section | Weight | Objectives |
|---|---|---|
| Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Debugging macros - Create and call macros |
| Transform or Summarize Clinical Trials Data | 15% | - Derive variables and study days - Data step manipulation - Aggregation and transposition |
| Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
| Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Use PROC COMPARE and log review - Validation principles |
| Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Access and explore clinical datasets - Clean, merge, and subset data |
| Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
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