ACRP ACRP Certified Professional ACRP-CP

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ACRP Certified Professional Sample Questions:

1. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The CRC should write a note to file.
B) The PI should amend the medical chart.
C) The PI should notify the monitor.
D) The CRC should amend the medical chart.

2. Who should vote during the IRB/IEC review and discussion process?

A) All IRB/IEC members and non-member experts
B) All IRB/IEC members
C) All members who were involved in the review and discussion
D) All members who were involved in the review and discussion and non-member experts

3. All of the following are examples of what monitors review EXCEPT:

A) Documentation in the participant's medical record of study drug administration.
B) Potential patient medical records for eligibility prior to the informed consent process.
C) The signed ICF retained in the participant's study file.
D) Regulatory binder which includes copies of current certifications for all laboratories.

4. 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) Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
D) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

5. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Randomization
B) Placebo-controlled
C) Blinding
D) Privacy controls

Solutions: