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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Clinical Study Operations | 15% | - Project management
|
| Study Design and Conduct | 17% | - Study implementation
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
| Ethical and Participant Safety Considerations | 19% | - Safety monitoring and reporting
|
| Data Management and Informatics | 17% | - Data collection
|
ACRP Certified Professional Sample Questions:
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?
- A. Regulatory authority
- B. Original reporting investigator
- C. Study sponsor
- D. Investigator at each site
Correct Answer: C 🗳️
Explanation: Only visible for ActualTestsIT 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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A study protocol must contain which of the following elements?
- A. Chemical structure of the IP
- B. Participant reimbursement details
- C. Data management plan
- D. Description of statistical methods
Correct Answer: D 🗳️
Explanation: Only visible for ActualTestsIT members. You can sign-up / login (it's free).
All site financial matters pertaining to a trial are listed in what document?
- A. Signed contract
- B. Protocol
- C. Financial disclosure
- D. Informed consent form
Correct Answer: A 🗳️
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A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?
- A. This needs to be reported to the regulatory authorities within 10 business days.
- B. This qualifies for expedited reporting to the sponsor.
- C. This qualifies for prompt reporting to the IRB/IEC within 15 business days.
- D. This needs to be reported to the patient's primary care physician.
Correct Answer: B 🗳️
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