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| Section | Weight | Objectives |
|---|---|---|
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
| Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Clean, merge, and subset data - Access and explore clinical datasets |
| Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Derive variables and study days - Data step manipulation |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
1. You are working with the VS data set that contains the variable Pulse.
Which PROC SGPLOT step will produce the graph shown below?
A) proc sgplot data = Work.VS noautolegend;
vbarbasic pulse;
density pulse;
run;
B) proc sgplot data = Work.VS noautolegend;
density pulse;
vbarbasic pulse;
run;
C) proc sgplot data = Work.VS noautolegend;
histogram pulse;
density pulse;
run;
D) proc sgplot data = Work.VS noautolegend;
density pulse;
histogram pulse;
run;
2. Which validation technique involves two programmers writing separate programs to produce the same output, then comparing the result?
A) Peer Review
B) Independent Programming
C) Identical Programming
D) Peer Matching
3. Which statement assigns the system date and time to the character variable CURRDTTM?
A) currdttm='&sysdate9 &systime';
B) currdttm="&sysdate9 &systime";
C) currdttm='%sysdate9 %systime';
D) currdttm="%sysdate9 %systime";
4. This question will ask you to provide a line of missing code.
Given the following log entry:
Which line of code would produce the merge issue notes in the log?
A) if indm ne indisp then output 'MERGE ISSUE: ' subjid= indm= indisp=;
B) %if indm ne indisp %then %put 'MERGE ISSUE: ' subjid= indm= indisp=;
C) if indm ne indisp then put 'MERGE ISSUE: ' _all_;
D) if indm ne indisp then put 'MERGE ISSUE: ' subjid= indm= indisp=;
5. Given the following complete dataset (WORK.TESTDM) with the variables USUBJID (character) and AGE (numeric):
The following code is executed:
proc sql;
select age into: age separated by ','
from testdm;
quit;
What is the value of the macro variable AGE?
A) Blank, the code will not execute
B) 17.1,17.7,4.4,3.8,6.3
C) 17, 17, 4, 3, 6
D) 17.1 17.7 4.4 3.8 6.3
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: B |
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