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ACRP Certified Professional Sample Questions:

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

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

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

3. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
B) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
C) They can attend the meeting and can vote/provide opinion on whether to approve the study.
D) They cannot be the PI on the clinical study due to conflict of interest.

4. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Audit
B) Site qualification
C) Inspection
D) Routine monitoring

5. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

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

Solutions: