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ACRP Certified Professional Sample Questions:

1. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Allow access to the entire records.
B) Deny the request until the sponsor approves.
C) Consult with the IRB/IEC first.
D) Redact subject identification for privacy protection.

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

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

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

4. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Approved by the IRB/IEC.
B) An employee of the institution.
C) Licensed to practice medicine.
D) Under the supervision of the PI.

5. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A) Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
B) Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
C) Reject the null hypothesis that the drug has no effect on cholesterol levels.
D) Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.

Solutions: