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ACRP Certified Professional Sample Questions:

1. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Audit
B) Routine monitoring
C) Inspection
D) Site qualification

2. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How likely are patients at high risk of cancer going to develop cancer during the study?
B) How does the risk of developing cancer compare to the anticipated side effects from the drug?
C) How willing are current patients to participate in a trial with potentially serious side effects?
D) How effective is the drug at treating patients that have been previously diagnosed with cancer?

3. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Monitor
B) Data Manager
C) Sponsor
D) QA Department

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

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

5. Who should vote during the IRB/IEC review and discussion process?

A) All members who were involved in the review and discussion
B) All members who were involved in the review and discussion and non-member experts
C) All IRB/IEC members
D) All IRB/IEC members and non-member experts

Solutions: