PASS GUARANTEED 2025 HIGH PASS-RATE ACRP ACRP-CP: ACRP CERTIFIED PROFESSIONAL EXAM POSITIVE FEEDBACK

Pass Guaranteed 2025 High Pass-Rate ACRP ACRP-CP: ACRP Certified Professional Exam Positive Feedback

Pass Guaranteed 2025 High Pass-Rate ACRP ACRP-CP: ACRP Certified Professional Exam Positive Feedback

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ACRP Certified Professional Exam Sample Questions (Q71-Q76):

NEW QUESTION # 71
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

  • A. The site should retain the essential documents longer to meet the regulatory requirements.
  • B. The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
  • C. The site may proceed with the destruction of the essential documents.
  • D. The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.

Answer: B

Explanation:
Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.
GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.
"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies." Objectives:
* Maintain compliance with document retention regulations.
* Prevent premature destruction of essential trial records.


NEW QUESTION # 72
A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

  • A. This qualifies for expedited reporting to the sponsor.
  • B. This needs to be reported to the patient's primary care physician.
  • C. This needs to be reported to the regulatory authorities within 10 business days.
  • D. This qualifies for prompt reporting to the IRB/IEC within 15 business days.

Answer: A

Explanation:
Any serious adverse event (SAE) that is unexpected, especially those involving congenital anomalies or birth defects, must be reported to the sponsor as an expedited safety report. The reporting should occur immediately to ensure prompt assessment and necessary action.
The answer aligns with ICH E6(R2) GCP guidelines, which require immediate reporting of SAEs related to IP use.
"Expedited reporting to the sponsor is required for unexpected serious adverse drug reactions, particularly those involving congenital anomalies." Objectives:
* Immediate safety reporting.
* Protecting the health of trial participants and their offspring.


NEW QUESTION # 73
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

  • A. IRB/IEC
  • B. CRO
  • C. Sponsor
  • D. Investigator

Answer: C

Explanation:
The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions before the trial begins. This includes outlining roles and responsibilities in collaboration with investigators, CROs, and other stakeholders. Proper delegation ensures the trial is conducted according to protocol and regulatory requirements.
This answer is verified based on GCP guidelines, which clearly state that sponsors are responsible for the organization and management of trial-related tasks.
"The sponsor is responsible for allocating duties and functions related to the conduct of the trial, ensuring compliance with regulatory and ethical standards." Objectives:
* Clarify the sponsor's role in clinical trial management
* Define responsibilities in trial planning


NEW QUESTION # 74
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

  • A. CRC
  • B. CRA
  • C. PI
  • D. Sponsor

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.


NEW QUESTION # 75
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 participant and assure proper care is provided.
  • B. Inform the monitor of the termination of the study.
  • C. Schedule participant for early termination visit.
  • D. Inform the IRB/IEC of the study closure.

Answer: A

Explanation:
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued." Objectives:
* Protect participant safety during study suspension.
* Maintain clear communication with study participants.


NEW QUESTION # 76
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