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ACRP Certified Professional Sample Questions:

1. Centralized monitoring can:

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

2. At a close-out visit, which document should be retained only at the site?

A) Treatment allocation
B) IP accountability
C) Subject identification code list
D) Final trial close-out monitoring report

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, quarantine and notify sponsor of the excursion.
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 and continue with subject allocation.

4. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) Sponsor
B) Health authority
C) DSMB/IDMC
D) Investigator

5. Which of the following reports should be retained in participant charts?

A) Safety reports
B) IRB/IEC progress reports
C) DSMB/IDMC reports
D) Lab reports

Solutions: