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ACRP Certified Professional Exam Sample Questions (Q117-Q122):

NEW QUESTION # 117
An impartial witness should be present during the entire informed consent discussion when:

A. A parent/guardian is consenting for a minor subject.
B. An interpreter is translating the consent form for a subject.
C. A legally acceptable representative is unable to read.
D. A subject has been determined to be vulnerable.

Answer: C

Explanation:
An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.
GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.
"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound." Objectives:
* Protect the rights of individuals with literacy challenges.
* Maintain ethical standards in the consent process.

NEW QUESTION # 118
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 submission of a data management plan to the regulatory authorities.
C. Ensure there is an accompanying written record that describes the consent process.
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 # 119
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. After the original planned data collection is completed
B. After the protocol amendment is approved by the IRB/IEC
C. As soon as the protocol amendment is submitted to the IRB/IEC
D. When the need for the additional data is discovered

Answer: B

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 120
Who determines the age of assent for pediatric studies?

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

Answer: C

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 # 121
SAEs must be reported immediately by the site to the:

A. Regulatory agency.
B. DSMB/IDMC.
C. IRB/IEC.
D. Sponsor.

Answer: D

Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.

NEW QUESTION # 122
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