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ACRP Certified Professional Exam Sample Questions (Q81-Q86):

NEW QUESTION # 81
Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

  • A. PI roles and responsibilities
  • B. Sample collection storage, disposal, and shipment requirements
  • C. Emerging animal toxicological and clinical data
  • D. Project feasibility considerations

Answer: C

Explanation:
Qualified experts should evaluate emerging animal toxicological and clinical data to assess potential safety implications for trial subjects. These data are critical in identifying potential risks, adverse effects, or safety concerns before exposing human subjects to the investigational product. Early detection of safety issues through expert evaluation helps protect participant well-being.
GCP guidelines stress the importance of expert assessment of preclinical and clinical data to identify risks and ensure participant safety.
"Emerging toxicological and clinical data should be carefully reviewed by qualified experts to identify safety concerns before clinical use." Objectives:
* Ensure participant safety through expert data analysis.
* Identify potential safety risks early in the trial process.


NEW QUESTION # 82
The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

  • A. The PI should amend the medical chart.
  • B. The CRC should write a note to file.
  • C. The CRC should amend the medical chart.
  • D. The PI should notify the monitor.

Answer: A

Explanation:
The PI is responsible for ensuring accurate documentation of adverse events (AEs) in the medical chart, including their relationship to the investigational product (IP). If an omission is identified, the PI must correct it by making a dated and signed amendment to maintain data accuracy and completeness.
GCP guidelines state that the PI must maintain accurate and complete records, including the assessment of the relationship between AEs and the IP.
"The investigator must document the assessment of the relationship between the AE and the investigational product to ensure accurate clinical records." Objectives:
* Maintain accuracy in adverse event documentation.
* Ensure data integrity through appropriate corrections.


NEW QUESTION # 83
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 the IRB/IEC of the study closure.
  • B. Inform participant and assure proper care is provided.
  • C. Schedule participant for early termination visit.
  • D. Inform the monitor of the termination of the study.

Answer: B

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 # 84
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

  • A. Develop a plan that describes the monitoring approach for a clinical study.
  • B. Conduct annual reviews of the protocol and accompanying study documents.
  • C. Ensure submission of a data management plan to the regulatory authorities.
  • D. Ensure there is an accompanying written record that describes the consent process.

Answer: A

Explanation:
Developing a monitoring plan that outlines the approach to quality assurance is essential for maintaining data integrity throughout the clinical trial. This plan helps identify critical data points, risk-based monitoring strategies, and procedures for detecting and correcting data discrepancies. It ensures that the study data collected is accurate, complete, and verifiable.
GCP guidelines emphasize the importance of a monitoring plan to safeguard the quality and integrity of study data.
"The sponsor should develop a comprehensive monitoring plan to ensure the accuracy, completeness, and consistency of trial data." Objectives:
* Maintain high-quality data through structured monitoring.
* Identify potential risks and address them proactively.


NEW QUESTION # 85
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

  • A. Medical monitor.
  • B. Regulatory authority.
  • C. Sponsor.
  • D. IRB/IEC.

Answer: C

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.


NEW QUESTION # 86
......

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