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ACRP Certified Professional Sample Questions:

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

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

2. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To escalate corrective actions to the regulatory authority
B) To determine if the deviations invalidate the data
C) To determine if a protocol amendment is needed
D) To establish a procedure for PI oversight of protocol deviations

3. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Report the AE to the sponsor.
B) Consult the IB.
C) Administer rescue medication.
D) Call the medical monitor.

4. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Information to be included in the advertising flyer
B) Location of stored trial records
C) Availability of qualified staff to conduct the trial
D) Length of time to receive the approved trial device

5. All of the following are examples of what monitors review EXCEPT:

A) The signed ICF retained in the participant's study file.
B) Potential patient medical records for eligibility prior to the informed consent process.
C) Regulatory binder which includes copies of current certifications for all laboratories.
D) Documentation in the participant's medical record of study drug administration.

Solutions: