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ACRP Certified Professional Sample Questions:

1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Under the supervision of the PI.
B) An employee of the institution.
C) Approved by the IRB/IEC.
D) Licensed to practice medicine.

2. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Principal Investigator
B) Medical monitor
C) Subject's primary care physician
D) Study pharmacovigilance physician

3. Who is responsible for submitting a protocol amendment to the IRB/IEC?

A) Investigator
B) CRA
C) CRC
D) Sponsor

4. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Attributable
B) Contemporaneous
C) Complete
D) Original

5. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Notify the PI.
B) Report a protocol deviation to the IRB/IEC.
C) Notify the sponsor.
D) Call the participant to return for an unscheduled visit.

Solutions: