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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The PI should notify the monitor.
B) The CRC should write a note to file.
C) The CRC should amend the medical chart.
D) The PI should amend the medical chart.

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 can attend the meeting, but should not 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 can attend the meeting and can vote/provide opinion on whether to approve the study.
D) They cannot be the PI on the clinical study due to conflict of interest.

3. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Investigator Brochure
B) Clinical Study Protocol
C) Clinical Study Report
D) IDMC/DSMB Report

4. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A) PI
B) CRC
C) IRB/IEC
D) CRA

5. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 4 participants
B) 5 participants
C) 6 participants
D) 3 participants

Solutions: