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ACRP Certified Professional Sample Questions:

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

2. Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A) Sponsor
B) PI
C) Subject
D) CRO

3. A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

A) Install an air cooler requiring regular water refills to maintain the room temperature.
B) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
C) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
D) Continue reporting temperature excursions per the pharmacy manual guidelines.

4. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Randomization
B) Privacy controls
C) Placebo-controlled
D) Blinding

5. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A) Placebo
B) Alternate dose
C) No treatment
D) Active control

Solutions: