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ACRP Certified Professional Sample Questions:

1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the subject.
B) Notify the sponsor.
C) Withdraw the subject.
D) Notify the regulatory authority.

2. 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) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
C) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
D) Continue reporting temperature excursions per the pharmacy manual guidelines.

3. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring report that identifies deviation from the approved protocol.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.

4. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A) IRB/IEC.
B) Sponsor.
C) Medical monitor.
D) Regulatory authority.

5. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) Data entry staff
C) Subject
D) IRB/IEC

Solutions: