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ACRP Certified Professional Sample Questions:

1. A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A) A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
B) A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
D) A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

2. Who takes responsibility for initiating a clinical trial?

A) Sponsor
B) IRB/IEC
C) Investigator
D) CRO

3. 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).

4. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Quarantine IP without registering in IWRS and request replacement from sponsor.
B) Register IP in IWRS and continue with subject allocation.
C) Dispose of IP and request replacement from sponsor.
D) Register IP in IWRS, quarantine and notify sponsor of the excursion.

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) Reduce the target sample size based on feedback from the sites.
B) Allocate additional monitoring resources to the trial.
C) Re-train investigators on recruitment obligations.
D) Evaluate the screen failures to determine if the protocol needs revision.

Solutions: