A brief introduction to the course

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A true simulation environment

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Concise contents

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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, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
B) A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, double-blind, 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. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How willing are current patients to participate in a trial with potentially serious side effects?
B) How effective is the drug at treating patients that have been previously diagnosed with cancer?
C) How likely are patients at high risk of cancer going to develop cancer during the study?
D) How does the risk of developing cancer compare to the anticipated side effects from the drug?

3. Who is responsible for the ongoing safety evaluation of the IP?

A) Sponsor
B) PI
C) Regulatory agency
D) IRB/IEC

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

5. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Verify subject eligibility
B) Ship/receive IP
C) Obtain IRB/IEC approval
D) Schedule a site initiation visit

Solutions: