Pass your actual test at first attempt with ACRP ACRP-CP training material
Updated: Jul 01, 2026
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1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:
A) Approved by the IRB/IEC.
B) Under the supervision of the PI.
C) An employee of the institution.
D) Licensed to practice medicine.
2. Which one of the following is a primary objective of a Phase III study of a new IP?
A) To show superiority over another treatment
B) To demonstrate or confirm therapeutic benefit
C) To establish dose information
D) To establish the safety profile
3. 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) Install an air cooler requiring regular water refills to maintain the room temperature.
B) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
C) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
D) Continue reporting temperature excursions per the pharmacy manual guidelines.
4. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:
A) A signed clinical trial agreement between the site and sponsor is in place.
B) The site receives approval from the medical monitor to begin enrolling.
C) The DSMB meets and the first DSMB meeting report has been issued.
D) The CRA has performed source document review and verification at the site.
5. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?
A) DSMB/IDMC
B) Sponsor
C) Health authority
D) Investigator
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: A | Question # 5 Answer: B |
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