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ACRP Certified Professional Sample Questions:

1. SAEs must be reported immediately by the site to the:

A) Sponsor.
B) DSMB/IDMC.
C) Regulatory agency.
D) IRB/IEC.

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring report that identifies deviation from the approved protocol.
B) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

3. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A) Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
B) Reject the null hypothesis that the drug has no effect on cholesterol levels.
C) Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
D) Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.

4. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Coordinator
C) Investigator
D) Sponsor

5. The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A) Inform participant and assure proper care is provided.
B) Inform the monitor of the termination of the study.
C) Schedule participant for early termination visit.
D) Inform the IRB/IEC of the study closure.

Solutions: