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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. SAEs must be reported immediately by the site to the:

A) Sponsor.
B) DSMB/IDMC.
C) IRB/IEC.
D) Regulatory agency.

2. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Accept this site and plan to undertake routine safety evaluations of the IP.
B) Before accepting this site, report the risk to the trial sponsor and await their decision.
C) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D) Accept this site and implement and maintain QA and QC systems with written SOPs.

3. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

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

4. After the site qualification visit report has been finalized, it must be:

A) Sent to the IRB/IEC for review and approval.
B) Kept in the CRO/sponsor's trial master file.
C) Stored in the sponsor's budgets and contracts file.
D) Included in the PI's regulatory file.

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

Solutions: