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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Data Management and Informatics | 17% | - Data collection
|
| Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Clinical Study Operations | 15% | - Site management
|
| Study Design and Conduct | 17% | - Study planning
|
ACRP Certified Professional Sample Questions:
1. The inclusion and exclusion criteria are in place so all subjects are:
A) Healthy and willing to complete the clinical trial.
B) Ethically vulnerable and patients with the disease under study.
C) Medically appropriate and protected from ethical vulnerability.
D) Patients with the disease under study and will not have any adverse events.
2. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?
A) A member of the research team
B) A witness
C) A family member
D) A legally acceptable representative
3. Which one of the following is a primary objective of a Phase III study of a new IP?
A) To demonstrate or confirm therapeutic benefit
B) To show superiority over another treatment
C) To establish dose information
D) To establish the safety profile
4. The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?
A) Inform the monitor of the termination of the study.
B) Inform the IRB/IEC of the study closure.
C) Inform participant and assure proper care is provided.
D) Schedule participant for early termination visit.
5. 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) Call the participant to return for an unscheduled visit.
B) Notify the PI.
C) Report a protocol deviation to the IRB/IEC.
D) Notify the sponsor.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: B |
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