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ACRP Certified Professional Sample Questions:

1. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
C) Permit PIs to select a monitor for their site as long as they are independent of the PI.
D) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Register IP in IWRS and continue with subject allocation.
B) Quarantine IP without registering in IWRS and request replacement from sponsor.
C) Dispose of IP and request replacement from sponsor.
D) Register IP in IWRS, quarantine and notify sponsor of the excursion.

3. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This qualifies for expedited reporting to the sponsor.
B) This needs to be reported to the regulatory authorities within 10 business days.
C) This qualifies for prompt reporting to the IRB/IEC within 15 business days.
D) This needs to be reported to the patient's primary care physician.

4. IP is dispensed to all subjects who:

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

5. The coding system for a double-blind clinical trial is accessible by the:

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

Solutions: