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ACRP Certified Professional Sample Questions:

1. Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A) 3.6 mg/dL
B) 2.6 mg/dL
C) 3.0 mg/dL
D) 1.8 mg/dL

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

3. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) PRO.
B) Source document.
C) Worksheet.
D) CRF.

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

5. The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A) Inform the IRB/IEC of the study closure.
B) Schedule participant for early termination visit.
C) Inform the monitor of the termination of the study.
D) Inform participant and assure proper care is provided.

Solutions: