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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Controlling risk by setting thresholds of risk acceptability.
B) Assessing risk based on study impact.
C) Documenting all possible risk scenarios.
D) Identifying potential study risks.

2. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) Sponsor
B) Investigator
C) Health authority
D) DSMB/IDMC

3. During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A) Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
B) Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
C) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
D) Immediately unblind the entire trial to ensure patient safety.

4. When designing a clinical trial, why is it important to define the study population?

A) To support subject recruitment to the study
B) To support the study objectives
C) To determine where to conduct the study
D) To determine the study objectives

5. Which of the following is a conflict of interest for a PI conducting a study?

A) A PI that presents at an investigator meeting
B) A PI who is a key opinion leader, writes the protocol
C) A PI that votes on the IRB/IEC approval of the protocol
D) A PI who receives payment for the study

Solutions: