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ACRP Certified Professional Sample Questions:

1. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Coordinator
C) Investigator
D) Sponsor

2. 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) Blinding
B) Privacy controls
C) Placebo-controlled
D) Randomization

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

4. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Time to occurrence of symptoms of the disease
B) Impact of an approved vaccine against the disease
C) Occurrence of known side effects of the IP
D) Use of concomitant medications to treat the symptoms

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

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

Solutions: