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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) Under the supervision of the PI.
D) Approved by the IRB/IEC.

2. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Original reporting investigator
B) Regulatory authority
C) Investigator at each site
D) Study sponsor

3. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, site coordinator CVs, and clinical trial agreement
B) Protocol, IB, and information about payments and compensation available to subjects
C) IB, site coordinator CVs, and information about payments and compensation available to subjects
D) Protocol, informed consent, and clinical trial agreement

4. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) Yes, the PI has a sufficient patient population to take part in this study.
B) No, the PI is taking part in too many ongoing studies to participate in this study.
C) No, the PI does not have the resources to perform all protocol-required procedures.
D) Yes, the PI can perform other imaging scans instead of the PET scans.

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

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

Solutions: