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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Manage Clinical Trials Data | 5% | - Access and explore clinical datasets - Use SQL and dictionary tables - Clean, merge, and subset data |
| Topic 2: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 3: Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Topic 4: Transform or Summarize Clinical Trials Data | 15% | - Derive variables and study days - Data step manipulation - Aggregation and transposition |
| Topic 5: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 6: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Topic 7: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 8: Macro Programming for Clinical Trials | 15% | - Create and call macros - Debugging macros - Macro variables and parameters |
| Topic 9: Clinical Trials Data Structures | 10% | - Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM |
1. A Statistical Analysis Plan defines study day as the number of days between the visit date and the date of randomization plus one day.
The following SAS program is submitted using a macro from the project's library:
How is the STUDYDAY macro defined?
A) %MACRO studyday(rand, visit);
&visit. ?&rand. + 1
%MEND studyday;
B) %MACRO studyday(rand=, visit=);
&vdt. ?&rdt. + 1
%MEND studyday;
C) %MACRO studyday(visit=, rand=);
&visit. ?&rand. + 1
%MEND studyday;
D) %MACRO studyday(rand, visit);
&vdt. ?&rdt. + 1
%MEND studyday;
2. The following output is displayed:
Which SAS program created this output?
A) proc freq data=WORK.TESTDATA; tables answer * gender / nocol norow nopercent missing;
B) proc freq data=WORK.TESTDATA; tables gender * answer / nocol norow nopercent; run;
C) proc freq data=WORK.TESTDATA; tables gender * answer / nocol norow nopercent missing; run;
D) proc freq data=WORK.TESTDATA; tables answer * gender / nocol norow nopercent; run;
3. Which SAS program will apply the data set label 'Demographics' to the data set named DEMO?
A) data demo; set demo;
label demo= 'Demographics';
run;
B) data demo;
set demo (label='Demographics');
run;
C) data demo (label 'Demographics');
set demo;
run;
D) data demo (label='Demographics');
set demo;
run;
4. This question will ask you to provide lines of missing code.
Given the following SCORE data set:
Variable LOCF contains the imputed score that would replace the missing SCORE value (based on last observation carried forward method).
Which SAS statements complete the program?
A) retain score; if first.subject then LOCF = .; if score ^= . then LOCF = score;
B) LOCF = lag(score); if first.subject then LOCF = .; if score ^= . then LOCF = score;
C) retain LOCF; if first.subject then LOCF = .; if score ^= . then LOCF = score;
D) if first.subject then LOCF = .; if score = . then LOCF = lag(score);
5. Given the data set RAWBP that is sorted by SUBJECT TEST WEEK:
Baseline is defined as the week 0 value. Your colleague provides the following SAS program to calculate change from baseline:
data bp;
set rawbp;
by subject test week;
retain baseline;
if first.subject then baseline = value;
if week > 0 then change = value - baseline;
run;
What does the code calculate as the change from baseline for systolic blood pressure (SBP) at week 3?
A) 30
B) 40
C) -40
D) -30
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: A |
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