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ACRP Certified Professional Exam Sample Questions (Q104-Q109):

NEW QUESTION # 104
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

A. Investigator
B. CRC
C. Sponsor
D. CRA

Answer: A

Explanation:
The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.
According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.
"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks." Objectives:
* Maintain compliance with GCP requirements.
* Ensure qualified personnel conduct study tasks.

NEW QUESTION # 105
Who determines the age of assent for pediatric studies?

A. Parent
B. PI
C. Sponsor
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 # 106
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A. Regulatory authority
B. Original reporting investigator
C. Investigator at each site
D. Study sponsor

Answer: D

Explanation:
The study sponsor is responsible for disseminating information about SAEs to all participating sites. This ensures consistent and timely communication of safety concerns, allowing each site to take appropriate actions in line with local regulations and IRB/IEC requirements.
The answer aligns with ICH E6(R2) GCP guidelines which mandate the sponsor to communicatesafety information to all investigators and sites involved in a multicenter trial.
"The sponsor must inform all investigators of safety information that could affect the conduct of the trial or the safety of subjects." Objectives:
* Maintain consistent safety reporting across all trial sites.
* Ensure regulatory compliance in multicenter trials.

NEW QUESTION # 107
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A. Before accepting this site, report the risk to the trial sponsor and await their decision.
B. Accept this site and implement and maintain QA and QC systems with written SOPs.
C. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D. Accept this site and plan to undertake routine safety evaluations of the IP.

Answer: A

Explanation:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively

NEW QUESTION # 108
Which statement does NOT represent a study monitor's responsibilities?

A. Report serious adverse events to the IRB/IEC.
B. Check the accuracy and completeness of case report forms with source documents.
C. Provide communication between the sponsor and the PI.
D. Verify that the PI has adequate qualifications and resources to conduct the study.

Answer: A

Explanation:
It is not the monitor's responsibility to report serious adverse events (SAEs) to the IRB/IEC. This responsibility typically falls on the PI or the sponsor. Monitors focus on data accuracy, protocol compliance, and communication between the site and the sponsor.
The answer follows GCP standards where the monitor's role is clearly defined, excluding SAE reporting to IRB/IEC.
"Monitors are responsible for verifying data accuracy and communicating with the sponsor but not for direct reporting of SAEs to the IRB/IEC." Objectives:
* Distinguish between the responsibilities of monitors and investigators
* Clarify SAE reporting protocols

NEW QUESTION # 109
......

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