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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Data Management and Informatics | 17% | - Data reporting
|
| Topic 2: Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Topic 3: Ethical and Participant Safety Considerations | 19% | - Safety monitoring and reporting
|
| Topic 4: Clinical Study Operations | 15% | - Project management
|
| Topic 5: Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Topic 6: Study Design and Conduct | 17% | - Study planning
|
ACRP Certified Professional Sample Questions:
The composition of an IDMC/DSMB should include which one of the following?
- A. A sponsor representative who is knowledgeable about the study's unblinded information
- B. A clinical scientist who is knowledgeable in the appropriate discipline
- C. A lead PI for the study
- D. A member from the IRB/IEC
Correct Answer: B 🗳️
Explanation: Only visible for DumpExam members. You can sign-up / login (it's free).
The PI may assign responsibility for IP accountability to the pharmacist provided they are:
- A. Approved by the IRB/IEC.
- B. Under the supervision of the PI.
- C. An employee of the institution.
- D. Licensed to practice medicine.
Correct Answer: B 🗳️
Explanation: Only visible for DumpExam members. You can sign-up / login (it's free).
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.
Correct Answer: A 🗳️
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Who is responsible to ensure training for key staff members unable to attend the site initiation visit?
- A. Investigator
- B. Sponsor
- C. Monitor
- D. Coordinator
Correct Answer: A 🗳️
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The PI should ensure that source data is:
- A. Printed directly from the EMR.
- B. Accurately reflected in the eCRFs.
- C. Kept on site for a minimum of 2 years.
- D. On worksheets that are provided by the sponsor.
Correct Answer: B 🗳️
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