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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Regulatory and Compliance Requirements | 17% | - International standards
|
| Topic 2: Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Topic 3: Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Topic 4: Data Management and Informatics | 17% | - Data collection
|
| Topic 5: Study Design and Conduct | 17% | - Study planning
|
| Topic 6: Clinical Study Operations | 15% | - Site management
|
ACRP Certified Professional Sample Questions:
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?
- A. 5 participants
- B. 3 participants
- C. 4 participants
- D. 6 participants
Correct Answer: B 🗳️
Explanation: Only visible for TestInsides 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. Immediately unblind the entire trial to ensure patient safety.
- B. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
- C. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
- D. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
Correct Answer: C 🗳️
Explanation: Only visible for TestInsides members. You can sign-up / login (it's free).
Which document confirms the PI's agreement to permit auditing at the study site?
- A. IB
- B. ICF
- C. Delegation Log
- D. Protocol
Correct Answer: B 🗳️
Explanation: Only visible for TestInsides members. You can sign-up / login (it's free).
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. All duties transferred to a CRO should be specified in writing.
- C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
- D. The IRB/IEC must approve the transfer of duties to a CRO.
Correct Answer: B 🗳️
Explanation: Only visible for TestInsides members. You can sign-up / login (it's free).
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.
Correct Answer: D 🗳️
Explanation: Only visible for TestInsides members. You can sign-up / login (it's free).
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