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ACRP Certified Professional Sample Questions:

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

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

2. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) Regulatory authority
B) CRO
C) Sponsor-Investigator
D) IRB/IEC

3. Which document confirms the PI's agreement to permit auditing at the study site?

A) Protocol
B) Delegation Log
C) IB
D) ICF

4. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) A monitoring report that identifies deviation from the approved protocol.
D) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.

5. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Approval of protocol by the PI.
D) Submission of documents to IRB/IEC and regulatory authority for review.

Solutions: