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ACRP Certified Professional Sample Questions:

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

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

2. After the completion or termination of a clinical trial, who should store the enrollment log?

A) Sponsor
B) Regulatory authority
C) CRO
D) PI

3. 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) Update the IB to add the risk of infection and submit to the sponsor for approval.
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) Add the risk of infection to the ICF and submit to the IRB/IEC for review.

4. 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) CRA
B) Sponsor
C) CRO
D) Data Manager

5. Who should vote during the IRB/IEC review and discussion process?

A) All IRB/IEC members and non-member experts
B) All members who were involved in the review and discussion
C) All members who were involved in the review and discussion and non-member experts
D) All IRB/IEC members

Solutions: