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ACRP ACRP-CP Exam Syllabus Topics:

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

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

A) Permit PIs to select a monitor for their site as long as they are independent of the PI.
B) Use central monitoring instead of conducting physical monitoring visits at sites.
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.

3. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A) Report this incident immediately to the sponsor and leave the treatment decision to them.
B) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
D) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.

4. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Controlling risk by setting thresholds of risk acceptability.
B) Identifying potential study risks.
C) Documenting all possible risk scenarios.
D) Assessing risk based on study impact.

5. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A) Data Manager
B) CRA
C) CRO
D) Sponsor

Solutions: