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ACRP Certified Professional Sample Questions:

1. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) CRF.
B) PRO.
C) Worksheet.
D) Source document.

2. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The CRC should write a note to file.
B) The PI should notify the monitor.
C) The CRC should amend the medical chart.
D) The PI should amend the medical chart.

3. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Attributable
B) Contemporaneous
C) Complete
D) Original

4. An impartial witness should be present during the entire informed consent discussion when:

A) A legally acceptable representative is unable to read.
B) A subject has been determined to be vulnerable.
C) An interpreter is translating the consent form for a subject.
D) A parent/guardian is consenting for a minor subject.

5. IP is dispensed to all subjects who:

A) Screened for the trial.
B) Consented for the trial.
C) Are eligible to receive it in the trial.
D) Need IP for their medical condition.

Solutions: