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ACRP Certified Professional Sample Questions:

1. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Study sponsor
B) Original reporting investigator
C) Investigator at each site
D) Regulatory authority

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

3. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Clinical Monitoring Plan
C) Data & Safety Monitoring Plan
D) Standard Operating Procedure

4. Who on the local site research study team is accountable for the unblinding documentation of IP?

A) CRC
B) PI
C) Pharmacist
D) Regulatory manager

5. Which of the following should be considered when implementing a risk-based monitoring plan?

A) On-site monitoring frequency may change depending on the quality of the data.
B) Monitoring schedule must be pre-defined in the monitoring plan.
C) Centralized monitoring must be incorporated in any trials.
D) 100% source document review is mandatory.

Solutions: