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ACRP Certified Professional Sample Questions:

1. A serious unexpected ADR is one:

A) That does not need to be reported to the IRB/IEC.
B) That results in the death of the subject.
C) Where the severity of the reaction is not consistent with IB.
D) Severity and nature of the reaction is consistent with protocol.

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

3. Which statement does NOT represent a study monitor's responsibilities?

A) Report serious adverse events to the IRB/IEC.
B) Provide communication between the sponsor and the PI.
C) Verify that the PI has adequate qualifications and resources to conduct the study.
D) Check the accuracy and completeness of case report forms with source documents.

4. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A) DSMB/IDMC
B) PI
C) IRB/IEC
D) Sponsor

5. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Regulatory Agency
B) PI
C) CRC
D) Sponsor

Solutions: