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ACRP Certified Professional Sample Questions:

1. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Risk-based audits of CRO activities as delegated
B) Co-monitoring of CRO site visits
C) Central monitoring of data fields by sponsor
D) Pre-qualification assessment of CRO

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

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

4. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) ICF
B) Protocol
C) IB
D) Package insert

5. 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) Continue reporting temperature excursions per the pharmacy manual guidelines.
B) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
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.

Solutions: