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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:
After the completion or termination of a clinical trial, who should store the enrollment log?
- A. Regulatory authority
- B. CRO
- C. PI
- D. Sponsor
Correct Answer: C 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
The coding system for a double-blind clinical trial is accessible by the:
- A. Regulatory authority
- B. IRB/IEC
- C. PI
- D. Sponsor
Correct Answer: D 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
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.
Correct Answer: C 🗳️
Explanation: Only visible for Real4Prep 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. 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.
Correct Answer: C 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
SAEs must be reported immediately by the site to the:
- A. Regulatory agency.
- B. IRB/IEC.
- C. Sponsor.
- D. DSMB/IDMC.
Correct Answer: C 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
