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ACRP Certified Professional Sample Questions:

1. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Consult the IB.
B) Administer rescue medication.
C) Report the AE to the sponsor.
D) Call the medical monitor.

2. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Regulatory Agency
B) PI
C) Sponsor
D) CRC

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

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

4. 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) QA Department
B) Data Manager
C) Monitor
D) Sponsor

5. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring report that identifies deviation from the approved protocol.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.

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