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ACRP Certified Professional Sample Questions:

1. Which one of the following is a primary objective of a Phase III study of a new IP?

A) To show superiority over another treatment
B) To establish dose information
C) To demonstrate or confirm therapeutic benefit
D) To establish the safety profile

2. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A) Validation
B) Quality Control
C) Programming
D) Quality Assurance

3. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, IB, and information about payments and compensation available to subjects
B) Protocol, site coordinator CVs, and clinical trial agreement
C) Protocol, informed consent, and clinical trial agreement
D) IB, site coordinator CVs, and information about payments and compensation available to subjects

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

5. 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) Sponsor
C) Data Manager
D) QA Department

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