Last Updated: Oct 04, 2026
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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Topic 2: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Topic 3: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 4: Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Access and explore clinical datasets - Clean, merge, and subset data |
| Topic 5: Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Create and call macros - Debugging macros |
| Topic 6: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 7: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 8: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 9: Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
This question will ask you to provide a missing option.
The following program is submitted to create a transport file for multiple data sets:
Which option will limit the files that are copied to type data?
Correct Answer: D 🗳️
Given the following data set:
Which program was used to prepare the data for this PROC PRINT output?
Correct Answer: A 🗳️
Which statement assigns the current date to the character variable CURRDT?
Correct Answer: C 🗳️
This question will ask you to provide a line of missing code.
Which statement must be added to the following program to create a page break in the report after each RACE grouping?
Correct Answer: A 🗳️
Which validation technique involves two programmers writing separate programs to produce the same output, then comparing the result?
Correct Answer: D 🗳️
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