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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

A root cause analysis should be:

A. Specific to a clinical trial.
B. Validated before use in a CAPA.
C. Focused on issues of non-compliance.
D. Written by the investigator.

Question 2

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

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

Question 3

The IB contains which of the following sections?

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

Question 4

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* 3 participants were withdrawn due to noncompliance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. 5 participants
B. 4 participants
C. 3 participants
D. 6 participants

Question 5

Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A. Emerging animal toxicological and clinical data
B. PI roles and responsibilities
C. Project feasibility considerations
D. Sample collection storage, disposal, and shipment requirements

Solutions: