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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 2: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 3: Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - Clinical domain structures - CDISC standards: SDTM, ADaM |
| Topic 4: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Topic 5: Macro Programming for Clinical Trials | 15% | - Debugging macros - Create and call macros - Macro variables and parameters |
| Topic 6: Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Data step manipulation - Derive variables and study days |
| Topic 7: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 8: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Topic 9: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
1. 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 log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
C) ods trace on; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
D) proc ttest data=WORK.DATA1 ods=trace; class TREAT; var RESULTS; run;
2. This question will ask you to provide a section of missing code.
Given the input SAS data set LABRAW:
Which DO LOOP will create the output SAS data set WORK.LAB_NEW?
A) do i=1 to 2; visit=i; date=dat{i}; result=num{i}; end; output;
B) do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; end; output; end;
C) do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; output; end;
D) do i=1 to 2; visit=i; date=dat{i}; result=num{i}; output; end;
3. A report that you are working on will require the following header lines:
Which code adds the second line of the header "Adverse Events"?
A) header2 'Adverse Events';
B) title2 'Adverse Events';
C) header2 = 'Adverse Events';
D) title2 = 'Adverse Events';
4. Given an existing work data set (DM), the following code is submitted:
A) MPRINT
B) MLOGIC
C) MRECALL
D) SYMBOLGEN
5. Which code segment would you use to derive the numeric variable AVAL from AVALC by stripping off non-numeric characters?
A) aval = put(compress(avalc, '<>='), best12.);
B) aval = put(substr(avalc, 2,2), best12.);
C) aval = input(substr(avalc, 2,2), best12.);
D) aval = input(compress(avalc, '<>='), best12.);
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: B | Question # 5 Answer: D |
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