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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. Given the following data set WORK.DM:

Which subjects will appear in the LOG file?

A) 003 and 004
B) 004 and 006
C) 001 and 006
D) 001 and 004

2. Given the following vital signs data: Baseline is defined as the last non-missing value prior to Day 1.

What is the value for the change from baseline for Week 1 for Subject 2?

A) 11
B) 23
C) -23
D) -11

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

4. Which two SDTM domains store information for the experimental design of the trial?
(Choose two.)

A) TE
B) TD
C) TA
D) TV

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

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

Solutions: