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ACRP Certified Professional Exam Sample Questions (Q76-Q81):

NEW QUESTION # 76
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
B. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
C. Update the IB to add the risk of infection and submit to the sponsor for approval.
D. Add the risk of infection to the ICF and submit to the IRB/IEC for review.

Answer: B

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.

NEW QUESTION # 77
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. Ensure there is an accompanying written record that describes the consent process.
C. Ensure submission of a data management plan to the regulatory authorities.
D. Conduct annual reviews of the protocol and accompanying study documents.

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 # 78
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A. Pre-qualification assessment of CRO
B. Risk-based audits of CRO activities as delegated
C. Co-monitoring of CRO site visits
D. Central monitoring of data fields by sponsor

Answer: B

Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.

NEW QUESTION # 79
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A. All duties transferred to a CRO should be specified in writing.
B. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C. The IRB/IEC must approve the transfer of duties to a CRO.
D. Any trial-related duties can be documented as transferred by verbal agreement.

Answer: A

Explanation:
When a sponsor transfers specific tasks to a Contract Research Organization (CRO), it must be documented in writing. This formal documentation clearly delineates responsibilities and ensures that both parties are aware of their roles and obligations. Verbal agreements are not sufficient forregulatory compliance.
ICH E6(R2) GCP guidelines mandate that all delegated tasks must be documented formally to ensure clarity and compliance.
"The sponsor should document in writing any responsibilities transferred to a CRO to ensure clear delineation of roles." Objectives:
* Maintain clear documentation of delegated tasks.
* Ensure compliance with regulatory standards.

NEW QUESTION # 80
Who determines the age of assent for pediatric studies?

A. PI
B. Sponsor
C. Parent
D. IRB/IEC

Answer: D

Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.

NEW QUESTION # 81
......

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