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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Topic 2: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Topic 3: Clinical Trials Data Structures | 10% | - Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM |
| Topic 4: Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Debugging macros - Create and call macros |
| Topic 5: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 6: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Topic 7: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 8: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 9: Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Validation principles - Programming validation techniques |
1. Review the following procedure code:
proc ttest data=DATA1;
class GROUPVAR1;
var VAR1;
run;
Which variable is most appropriate to be analyzed as variable VAR1?
A) Age, with possible values of any integer between and including 18 and 65
B) Treatment, with possible values of "Placebo" or "Active"
C) Number of infections, with possible values of 0, 1, or 2
D) Systolic blood pressure, with possible values of "<120", "120 - 139", "140 - 159", "160 - 179", and
"180+"
2. Study day is defined as DCMDATE minus RFSTDTC +1
Which statement will compute the study day correctly without producing notes for missing values in the log?
A) STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;
B) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,date9.)- input(RFSTDTC,yymmdd8.)+1;
C) STUDYDAY=DCMDATE-RFSTDTC+1;
D) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,yymmdd8.)- input(RFSTDTC,date9.)+1;
3. Given the SAS data set WORK.BP
What is the result?
A) WORK.HIGHBP has 2 observations
WORK.NORMBP has 2 observations
WORK.INVESTBP has 3 observations
B) WORK.HIGHBP has 1 observation
WORK.NORMBP has 1 observation
WORK.INVESTBP has 2 observations
C) WORK.HIGHBP has 1 observation
WORK.NORMBP has 1 observation
WORK.INVESTBP has 3 observations
D) WORK.HIGHBP has 1 observation
WORK.NORMBP has 1 observation
WORK.INVESTBP has 4 observations
4. Given the data set HE:
What will the values be of variable HOSPDURD for the two subjects?
A) missing, missing
B) 50, 9
C) 65, 9
D) 5, missing
5. Which OPTION displays all SAS language statements generated during macro execution?
A) MSTORED
B) MLOGIC
C) MPRINT
D) MRECALL
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: A | Question # 5 Answer: C |
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