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| Section | Weight | Objectives |
|---|---|---|
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
| Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM - Clinical domain structures |
| Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Data step manipulation - Derive variables and study days |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
1. Given the following two data sets EX and AE:
Which output data set is produced by the submitted SAS program?
A) Option A
B) Option C
C) Option B
D) Option D
2. What is the main focus of Good Clinical Practices (GCP)?
A) protection of subjects
B) harmonized data collection
C) standard monitoring practices
D) standard analysis practices
3. Which program will report all created output objects in the log?
A) ods trace=log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
B) proc ttest data=WORK.DATA1 ods=trace; class TREAT; var RESULTS; run;
C) ods trace log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
D) ods trace on; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
4. Given the following data set DEMOG:
Which selection below would be considered hard-coding?
A) if site eq 1 then sexcd = 2; else if site eq 2 then sexcd = 1;
B) if sexcd eq 1 then sex = "Male"; else if sexcd eq 2 then sex = "Female";
C) if site eq 1 and sexcd ne 2 then check = 1; else if site eq 2 and sexcd ne 1 then check = 2;
D) birthdt = input(dob, mmddyy10.);
5. What is the definition for treatment-emergent adverse event (TEAE)?
A) AE that started or worsened after the first dose of study drug
B) AE that continued after the first dose of study drug
C) AE that started 6 months after the last dose of study drug
D) AE that improved after the first dose of study drug
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: A | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: A |
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