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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Data Management and Documentation | - Clinical trial documentation
|
| Topic 2: Quality Management | - Risk management
|
| Topic 3: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 4: Professional Responsibilities | - Communication and collaboration
|
| Topic 5: Clinical Trial Operations | - Study conduct
|
ACRP Certified Professional Sample Questions:
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:
- A. 8 calendar days
- B. 15 calendar days
- C. 30 calendar days
- D. 7 calendar days
Correct Answer: B 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?
- A. Install an air cooler requiring regular water refills to maintain the room temperature.
- B. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
- C. Return all IP and request the CRO/Sponsor to directly ship IP to participants.
- D. Continue reporting temperature excursions per the pharmacy manual guidelines.
Correct Answer: B 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?
- A. Investigator
- B. CRO
- C. IRB/IEC
- D. Sponsor
Correct Answer: D 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
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. Register IP in IWRS and continue with subject allocation.
- B. Quarantine IP without registering in IWRS and request replacement from sponsor.
- C. Dispose of IP and request replacement from sponsor.
- D. Register IP in IWRS, quarantine and notify sponsor of the excursion.
Correct Answer: D 🗳️
Explanation: Only visible for Real4Prep members. You can sign-up / login (it's free).
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
- A. Ensure there is an accompanying written record that describes the consent process.
- B. Develop a plan that describes the monitoring approach for a clinical study.
- C. Conduct annual reviews of the protocol and accompanying study documents.
- D. Ensure submission of a data management plan to the regulatory authorities.
Correct Answer: B 🗳️
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