ACRP : ACRP-CP Questions & Answers

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. 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) Quality Assurance
B) Programming
C) Validation
D) Quality Control

2. The IB contains which of the following sections?

A) Known pharmacokinetic effects
B) Participant dosing schedule
C) IP preparation instructions
D) Participant eligibility criteria

3. 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 and can vote/provide opinion on whether to approve the study.
D) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.

4. Who takes responsibility for initiating a clinical trial?

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

5. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
B) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C) Update the IB to add the risk of infection and submit to the sponsor for approval.
D) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

Solutions: