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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. A Treatment-Emergent Adverse Event (TEAE) is commonly defined as any event that occurs on or after the date and time of:

A) study enrollment
B) informed consent
C) first dose of study drug
D) baseline assessment

2. A Statistical Analysis Plan (SAP) defines the selection process for baseline records. This instructs the programmer to choose the last non-missing analyte value prior to first study drug administration (date/time).
The DEMO data set contains the date/time of first study drug administration for subject:

What will be the resulting baseline values, as selected per the SAP instructions?

A) Option A
B) Option D
C) Option C
D) Option B

3. Which COMPUTE block correctly completes the code shown below to compute the ratio of the median Length to the median Weight?
proc report data = DM;
columns USUBJID Ratio Length Weight;
define USUBJID / group;
define Ratio / computed;
define Length / analysis median;
define Weight / analysis median;
run;

A) compute Weight;
Ratio = Length / Weight;
endcomp;
B) compute Ratio;
Ratio = Length/ Weight;
endcomp;
C) compute Ratio;
Ratio = Length.Median / Weight.Median;
endcomp;
D) compute Weight;
Ratio = Length.Median / Weight.Median;
endcomp;

4. You want to calculate the p-value of Fisher's exact test for a 3x3 table.
Which option must you add to the TABLES statement of PROC FREQ?

A) CHISQ
B) EXACT
C) CMH
D) EXPECTED

5. In a study, inclusion criteria required patients be between 18 and 65. Patients will be analyzed in 2 age groups: group one is subjects who are under 36 years of age and group two is subjects who are 36 years of age or older.
Which statements properly assign age group, and writes an error message to the log for any patient with an out of range age value?

A) select;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; when (36 <= age < 66) agegrp = 2; when (18 <= age < 66) agegrp = 1; end;
B) select;
when (18 <= age < 36) agegrp = 1;
when (36 <= age < 66) agegrp = 2;
otherwise put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; end;
C) select;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; when (age >= 36) agegrp = 2; when (age >= 18) agegrp = 1; otherwise; end;
D) select;
when (age >= 18) agegrp = 1;
when (age >= 36) agegrp = 2;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; end;

Solutions: