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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

A) Sponsor
B) CRC
C) PI
D) CRO

2. 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) Immediately unblind the entire trial to ensure patient safety.
D) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

3. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Executive board members.
B) Independent qualified individuals.
C) Regulatory authority expert advisors.
D) Investigators participating in the trial.

4. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Notify the sponsor.
B) Notify the PI.
C) Call the participant to return for an unscheduled visit.
D) Report a protocol deviation to the IRB/IEC.

5. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To determine if the deviations invalidate the data
B) To escalate corrective actions to the regulatory authority
C) To establish a procedure for PI oversight of protocol deviations
D) To determine if a protocol amendment is needed

Solutions: