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ACRP Certified Professional Sample Questions:

1. A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A) Recruit for the study without use of social media.
B) Use a central IRB/IEC.
C) Decline the study.
D) Rely on the sponsor to notify the IRB/IEC.

2. Which of the following is a conflict of interest for a PI conducting a study?

A) A PI that votes on the IRB/IEC approval of the protocol
B) A PI who is a key opinion leader, writes the protocol
C) A PI who receives payment for the study
D) A PI that presents at an investigator meeting

3. 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) Investigator
B) DSMB/IDMC
C) Sponsor
D) Health authority

4. Which of the following statements is TRUE about an EDC system?

A) A separate workstation should be made available for the monitor.
B) There should be an audit trail to track data entries, deletions, and changes.
C) The eCRF should be an exact page-by-page replica of the paper CRF.
D) IRB/IEC approval is required before the use of the computerized system.

5. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A family member
B) A member of the research team
C) A witness
D) A legally acceptable representative

Solutions: