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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. What is the definition for treatment-emergent adverse event (TEAE)?

A) AE that started or worsened after the first dose of study drug
B) AE that continued after the first dose of study drug
C) AE that improved after the first dose of study drug
D) AE that started 6 months after the last dose of study drug

2. In CDISC, which of the following describes the usage of controlled terms, code lists, or formats?

A) Establishes consistent variable names.
B) Establishes consistent variable types.
C) Establishes consistent variable labels
D) Establishes consistent variable values

3. Vital Signs are a component of which SDTM class?

A) Findings
B) Interventions
C) Special Purpose
D) Events

4. Given the following data set:

Which type of clinical trials data is this?

A) Laboratory
B) Vital Signs
C) Demographics
D) Medical History

5. This item will ask you to determine the missing code.
In the data shown below, each record represents a single treatment period and contains a character SUBJID and non-missing numeric dates EXSTDT and EXENDT.
The Duration of Treatment (in days) for a single period is defined as Treatment End Date - Treatment Start Date + 1. For each subject, the Total Duration (in days) is defined as the sum of durations of treatment across all treatment periods.

Which code segment generates the new data set, EX2, which contains a single record per subject and includes the Duration of Treatment?
data EX2
set EX;
by subjid exstdt exendt;
<insert code here>
run;

A) duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt;
B) retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then Totaldur = duration;
if last.subjid;
C) retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt;
D) duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then TotalDur = duration;
if last.subjid;

Solutions: