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ACRP Certified Professional Sample Questions:

1. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Administer rescue medication.
B) Consult the IB.
C) Report the AE to the sponsor.
D) Call the medical monitor.

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

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

4. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A) PI
B) IRB/IEC
C) DSMB/IDMC
D) Sponsor

5. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) PD affected participant safety.
B) PD affected participant recruitment.
C) Sponsor approved the PD.
D) Participant verbally agreed to the PD.

Solutions: