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ACRP Certified Professional Sample Questions:

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

2. All site financial matters pertaining to a trial are listed in what document?

A) Informed consent form
B) Signed contract
C) Protocol
D) Financial disclosure

3. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The number of unique eCRF templates was not specified.
B) The list of comparable technology solutions was not included.
C) The frequency of data backup was not defined.
D) The number of users with access was not defined.

4. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Call the medical monitor.
B) Report the AE to the sponsor.
C) Consult the IB.
D) Administer rescue medication.

5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) PI
B) Applicable regulatory authorities
C) Sponsor
D) Applicable site SOPs

Solutions: