ACRP Certified Professional : ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

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. 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. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

Question 2

A study protocol must contain which of the following elements?

A. Data management plan
B. Participant reimbursement details
C. Chemical structure of the IP
D. Description of statistical methods

Question 3

Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A. Report a protocol deviation to the IRB/IEC.
B. Notify the sponsor.
C. Call the participant to return for an unscheduled visit.
D. Notify the PI.

Question 4

A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A. Group sequential
B. Parallel Group
C. Crossover
D. Factorial

Question 5

In a quality management system, in which category do risk reduction activities belong?

A. Risk Communication
B. Risk Review
C. Risk Evaluation
D. Risk Control

Solutions: