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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Quality Management | - Audit and inspection readiness
|
| Clinical Trial Operations | - Study start-up activities
|
| Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Professional Responsibilities | - Communication and collaboration
|
| Data Management and Documentation | - Clinical trial documentation
|
ACRP Certified Professional Sample Questions:
1. After the completion or termination of a clinical trial, who should store the enrollment log?
A) Regulatory authority
B) CRO
C) PI
D) Sponsor
2. The coding system for a double-blind clinical trial is accessible by the:
A) Regulatory authority
B) IRB/IEC
C) PI
D) Sponsor
3. Which strategy is used to safeguard subject privacy?
A) Utilize subject initials on correspondence.
B) Email updated enrollment logs to the CRA.
C) Conduct subject-related conversations in controlled environments.
D) Store source documentation in the CRC's office.
4. 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 sponsor.
C) Notify the PI.
D) Report a protocol deviation to the IRB/IEC.
5. SAEs must be reported immediately by the site to the:
A) Regulatory agency.
B) IRB/IEC.
C) Sponsor.
D) DSMB/IDMC.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: C |
