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ACRP Certified Professional Sample Questions:

1. The investigator/institution should permit:

A) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
B) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
C) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
D) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).

2. A study protocol must contain which of the following elements?

A) Description of statistical methods
B) Data management plan
C) Chemical structure of the IP
D) Participant reimbursement details

3. At a close-out visit, which document should be retained only at the site?

A) Treatment allocation
B) Final trial close-out monitoring report
C) Subject identification code list
D) IP accountability

4. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) ICF
B) Package insert
C) IB
D) Protocol

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

Solutions: