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ACRP Certified Professional Sample Questions:

1. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Crossover
B) Group sequential
C) Parallel Group
D) Factorial

2. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Report
B) Investigator Brochure
C) Clinical Study Protocol
D) IDMC/DSMB Report

3. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Monitor
B) Data Manager
C) Sponsor
D) QA Department

4. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 7 calendar days
B) 8 calendar days
C) 15 calendar days
D) 30 calendar days

5. Which of the following reports should be retained in participant charts?

A) DSMB/IDMC reports
B) Lab reports
C) Safety reports
D) IRB/IEC progress reports

Solutions: