ACRP Certified Professional - ACRP-CP certification

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A) DSMB/IDMC
B) PI
C) IRB/IEC
D) Sponsor

2. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the sponsor.
B) Withdraw the subject.
C) Notify the subject.
D) Notify the regulatory authority.

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) 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.

4. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
B) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C) Report this incident immediately to the sponsor and leave the treatment decision to them.
D) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.

5. Which statement does NOT represent a study monitor's responsibilities?

A) Provide communication between the sponsor and the PI.
B) Check the accuracy and completeness of case report forms with source documents.
C) Report serious adverse events to the IRB/IEC.
D) Verify that the PI has adequate qualifications and resources to conduct the study.

Solutions: