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ACRP Certified Professional Sample Questions:

1. 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) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
D) Install an air cooler requiring regular water refills to maintain the room temperature.

2. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Worksheet.
B) PRO.
C) Source document.
D) CRF.

3. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To escalate corrective actions to the regulatory authority
B) To determine if a protocol amendment is needed
C) To determine if the deviations invalidate the data
D) To establish a procedure for PI oversight of protocol deviations

4. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Permit PIs to select a monitor for their site as long as they are independent of the PI.
C) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
D) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.

5. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Emerging animal toxicological and clinical data
B) Project feasibility considerations
C) Sample collection storage, disposal, and shipment requirements
D) PI roles and responsibilities

Solutions: