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ACRP Certified Professional Sample Questions:

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

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

2. An impartial witness should be present during the entire informed consent discussion when:

A) A parent/guardian is consenting for a minor subject.
B) A subject has been determined to be vulnerable.
C) A legally acceptable representative is unable to read.
D) An interpreter is translating the consent form for a subject.

3. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Schedule a site initiation visit
B) Obtain IRB/IEC approval
C) Ship/receive IP
D) Verify subject eligibility

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

5. Which strategy is used to safeguard subject privacy?

A) Utilize subject initials on correspondence.
B) Conduct subject-related conversations in controlled environments.
C) Email updated enrollment logs to the CRA.
D) Store source documentation in the CRC's office.

Solutions: