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ACRP Certified Professional Sample Questions:

1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the subject.
B) Notify the regulatory authority.
C) Withdraw the subject.
D) Notify the sponsor.

2. 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 can attend the meeting and can vote/provide opinion on whether to approve the study.
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.

3. In a quality management system, in which category do risk reduction activities belong?

A) Risk Control
B) Risk Evaluation
C) Risk Review
D) Risk Communication

4. The inclusion and exclusion criteria are in place so all subjects are:

A) Patients with the disease under study and will not have any adverse events.
B) Healthy and willing to complete the clinical trial.
C) Medically appropriate and protected from ethical vulnerability.
D) Ethically vulnerable and patients with the disease under study.

5. Who takes responsibility for initiating a clinical trial?

A) Sponsor
B) IRB/IEC
C) Investigator
D) CRO

Solutions: