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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Clinical Study Operations | 15% | - Site management
|
| Data Management and Informatics | 17% | - Data collection
|
| Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
| Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Ethical and Participant Safety Considerations | 19% | - Safety monitoring and reporting
|
| Study Design and Conduct | 17% | - Study implementation
|
ACRP Certified Professional Sample Questions:
1. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
A) Redact subject identification for privacy protection.
B) Deny the request until the sponsor approves.
C) Consult with the IRB/IEC first.
D) Allow access to the entire records.
2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A) Dispose of IP and request replacement from sponsor.
B) Register IP in IWRS, quarantine and notify sponsor of the excursion.
C) Quarantine IP without registering in IWRS and request replacement from sponsor.
D) Register IP in IWRS and continue with subject allocation.
3. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?
A) ICF
B) Package insert
C) Protocol
D) IB
4. Who ensures information regarding payments to subjects is documented in a written consent form?
A) Coordinator
B) PI
C) IRB/IEC
D) Sponsor
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) Notify the sponsor.
B) Call the participant to return for an unscheduled visit.
C) Report a protocol deviation to the IRB/IEC.
D) Notify the PI.
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: D |


