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ACRP Certified Professional Sample Questions:
1. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
A) Sponsor
B) Investigator
C) CRC
D) CRA
2. 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) Yes, the PI has a sufficient patient population to take part 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.
3. The investigator/institution should permit:
A) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
B) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
C) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
D) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
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) The CRA has performed source document review and verification at the site.
B) A signed clinical trial agreement between the site and sponsor is in place.
C) The DSMB meets and the first DSMB meeting report has been issued.
D) The site receives approval from the medical monitor to begin enrolling.
5. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?
A) Allocate additional monitoring resources to the trial.
B) Evaluate the screen failures to determine if the protocol needs revision.
C) Re-train investigators on recruitment obligations.
D) Reduce the target sample size based on feedback from the sites.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: B | Question # 5 Answer: B |
