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ACRP Certified Professional Sample Questions:

1. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A) Active control
B) Alternate dose
C) No treatment
D) Placebo

2. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Occurrence of known side effects of the IP
B) Use of concomitant medications to treat the symptoms
C) Impact of an approved vaccine against the disease
D) Time to occurrence of symptoms of the disease

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

4. Who is responsible for the ongoing safety evaluation of the IP?

A) PI
B) IRB/IEC
C) Sponsor
D) Regulatory agency

5. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Location of stored trial records
B) Availability of qualified staff to conduct the trial
C) Length of time to receive the approved trial device
D) Information to be included in the advertising flyer

Solutions: