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ACRP Certified Professional Sample Questions:

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

2. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Coordinator
C) Sponsor
D) Investigator

3. Who determines the age of assent for pediatric studies?

A) Parent
B) Sponsor
C) IRB/IEC
D) PI

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

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

5. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They can attend the meeting and can vote/provide opinion on whether to approve the study.
B) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
C) They cannot be the PI on the clinical study due to conflict of interest.
D) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.

Solutions: