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

2. You want 90% confidence limits for a binomial proportion from a one-way table with PROC FREQ.
Which option must you add to the TABLES statement?

A) BINOMIAL ALPHA=0.9
B) BINOMIAL
C) BINOMIAL ALPHA=0.1
D) BINOMIAL ALPHA=90

3. 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) -23
B) -11
C) 23
D) 11

4. The following partial output was produced from the SAS Dictionary Tables.

Which SQL statement produced this output?

A) proc sql;
select * from dictionary.macros
where scope = 'GLOBAL';
quit;
B) proc sql;
select scope, name from dictionary.macros
where scope = 'GLOBAL';
quit;
C) proc sql;
select * from dictionary.macros
where scope = 'global';
quit;
D) proc sql;
select scope, name from dictionary.macros
where scope = 'global';
quit;

5. Identify the CDISC model with the following characteristics:
XML-based content and format standard facilitates the archive and interchange of the metadata and data for clinical research provides an accurate audit trail that is 21 CRF Part II compliant

A) Analysis Data Model (ADaM)
B) Study Data Tabulation Model (SDTM)
C) Trial Design Model (TDM)
D) Operational Data Model (ODM)

Solutions: