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ACRP Certified Professional Sample Questions:

1. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
B) Update the IB to add the risk of infection and submit to the sponsor for approval.
C) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
D) Add the risk of infection to the ICF and submit to the IRB/IEC for review.

2. Centralized monitoring can:

A) Enable appropriate stratification of subject enrollment.
B) Identify IP accountability and storage issues.
C) Confirm why sites are deviating from the protocol.
D) Indicate the need to send monitors to perform onsite visits.

3. 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.

4. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A) Regulatory authority.
B) Sponsor.
C) IRB/IEC.
D) Medical monitor.

5. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A) Ensure submission of a data management plan to the regulatory authorities.
B) Conduct annual reviews of the protocol and accompanying study documents.
C) Develop a plan that describes the monitoring approach for a clinical study.
D) Ensure there is an accompanying written record that describes the consent process.

Solutions: