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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. 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) 30
D) -40

2. The VISIT data set is multiple records per subject, sorted by usubjid vistdtc vistm and contains the following variables:

The DEATH data set is one record per subject, sorted by usubjid vistdtc vistm and contains the following variables:

Which program will combine the DEATH and VISIT data sets by matching records?

A) data data_1;
merge death visit;
by usubjid vistm vistdtc;
run;
B) data data_1;
set death visit;
by usubjid vistdtc vistm;
run;
C) data data_1;
merge death visit;
by usubjid vistdtc vistm;
run;
D) data data_1;
merge death visit;
run;

3. The purpose of the ADaM model is to provide a framework that:

A) can be used to generate the CDISC ODM
B) enables the statistical analysis of the data
C) enables the tabulation of the raw source data
D) enables the creation of study patient profiles

4. In a Statistical Analysis Plan (SAP) the following statement is written:
To test the association between the pain intensity reported by the patient and the treatment the patient has been administered, a Cochran-Mantel-Haenszel test will be performed adjusting for the country of the patient's investigational site.
The following variables and levels are used:
- Pain intensity (PAIN): "No pain", "Mild pain", "Moderate pain", "Severe pain", "Most severe pain"
- Treatment group (TREAT): "Placebo", "Drug A", "Drug B"
- Country (COUNTRY): Eight different values.
The following program is written to perform this analysis:
proc freq data=pain;
by COUNTRY;
tables PAIN * TREAT / cmh;
run;
This code does not produce the analysis requested by the SAP.
What is wrong with this code?

A) The variable COUNTRY should be on the TABLES statement instead of the BY statement.
B) The option CMH should be on the PROC FREQ statement instead of on the TABLES statement.
C) The variable PAIN should be on the BY statement along with the variable COUNTRY.
D) The variables PAIN and TREAT should be on the BY statement, and the variable COUNTRY should be on the TABLES statement.

5. Define.xml is an XML-based submission of a clinical study's:

A) protocol
B) metadata
C) results
D) data

Solutions: