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ACRP Certified Professional Sample Questions:

1. What would a sponsor use to implement and maintain quality in a study?

A) Standard operating procedures
B) Clinical trial agreement
C) Protocol signature pages
D) Statistical analysis plan

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

3. Which of the following reports should be retained in participant charts?

A) Lab reports
B) IRB/IEC progress reports
C) DSMB/IDMC reports
D) Safety reports

4. Which document confirms the PI's agreement to permit auditing at the study site?

A) Protocol
B) Delegation Log
C) ICF
D) IB

5. The composition of an IDMC/DSMB should include which one of the following?

A) A sponsor representative who is knowledgeable about the study's unblinded information
B) A member from the IRB/IEC
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A lead PI for the study

Solutions: