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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. 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) Time to occurrence of symptoms of the disease
D) Impact of an approved vaccine against the disease

2. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The frequency of data backup was not defined.
B) The number of users with access was not defined.
C) The list of comparable technology solutions was not included.
D) The number of unique eCRF templates was not specified.

3. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To escalate corrective actions to the regulatory authority
B) To determine if the deviations invalidate the data
C) To establish a procedure for PI oversight of protocol deviations
D) To determine if a protocol amendment is needed

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) Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
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) Immediately unblind the entire trial to ensure patient safety.

5. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Any trial-related duties can be documented as transferred by verbal agreement.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) All duties transferred to a CRO should be specified in writing.
D) The IRB/IEC must approve the transfer of duties to a CRO.

Solutions: