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ACRP Certified Professional Sample Questions:

1. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A family member
B) A legally acceptable representative
C) A member of the research team
D) A witness

2. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Sponsor
C) Investigator
D) Coordinator

3. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Report
B) Investigator Brochure
C) Clinical Study Protocol
D) IDMC/DSMB Report

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

5. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Complete
B) Contemporaneous
C) Original
D) Attributable

Solutions: