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| Section | Weight | Objectives |
|---|---|---|
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Debugging macros - Macro variables and parameters |
| Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM - Clinical domain structures |
| Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Validation principles - Use PROC COMPARE and log review |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Manage Clinical Trials Data | 5% | - Access and explore clinical datasets - Use SQL and dictionary tables - Clean, merge, and subset data |
| Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Derive variables and study days - Data step manipulation |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
Question 1
Which SAS program will apply the data set label 'Demographics' to the data set named DEMO?
A. data demo;
set demo (label='Demographics');
run;
B. data demo (label='Demographics');
set demo;
run;
C. data demo; set demo;
label demo= 'Demographics';
run;
D. data demo (label 'Demographics');
set demo;
run;
Question 2
Which OPTION displays all SAS language statements generated during macro execution?
A. MLOGIC
B. MRECALL
C. MSTORED
D. MPRINT
Question 3
What is the main focus of 21 CFR Part 11?
A. trial safety requirements
B. electronic submission requirements
C. trial protocol requirements
D. statistical calculation requirements
Question 4
In CDISC, which of the following describes the usage of controlled terms, code lists, or formats?
A. Establishes consistent variable values
B. Establishes consistent variable names.
C. Establishes consistent variable labels
D. Establishes consistent variable types.
Question 5
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. ods trace on; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
C. proc ttest data=WORK.DATA1 ods=trace; class TREAT; var RESULTS; run;
D. ods trace log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
Solutions:
| Question 1 Answer: B | Question 2 Answer: D | Question 3 Answer: B | Question 4 Answer: A | Question 5 Answer: B |
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