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ACRP Certified Professional Sample Questions:

1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the sponsor.
B) Notify the subject.
C) Notify the regulatory authority.
D) Withdraw the subject.

2. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
B) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
C) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D) Update the IB to add the risk of infection and submit to the sponsor for approval.

3. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Independent qualified individuals.
B) Executive board members.
C) Investigators participating in the trial.
D) Regulatory authority expert advisors.

4. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) An employee of the institution.
B) Approved by the IRB/IEC.
C) Under the supervision of the PI.
D) Licensed to practice medicine.

5. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Coordinator
B) Monitor
C) Investigator
D) Sponsor

Solutions: