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Quiz 2025 ACRP ACRP-CP Pass-Sure Exam Pattern
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ACRP Certified Professional Exam Sample Questions (Q38-Q43):
NEW QUESTION # 38
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
- A. Privacy controls
- B. Randomization
- C. Blinding
- D. Placebo-controlled
Answer: B
Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.
NEW QUESTION # 39
SAEs must be reported immediately by the site to the:
- A. Regulatory agency.
- B. Sponsor.
- C. IRB/IEC.
- D. DSMB/IDMC.
Answer: B
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 # 40
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
- A. Conduct annual reviews of the protocol and accompanying study documents.
- B. Develop a plan that describes the monitoring approach for a clinical study.
- 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: B
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 # 41
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?
- A. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
- B. Interview participants who have dropped out.
- C. Require participants to provide documented reason for withdrawal.
- D. Meet with the site staff to understand their workflows and to review retention strategies.
Answer: D
Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.
NEW QUESTION # 42
A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?
- A. ICF
- B. Protocol
- C. IB
- D. Package insert
Answer: A
Explanation:
The Informed Consent Form (ICF) contains comprehensive information about the potential risks and benefits of participation in a clinical trial. It is a legally required document that ensures that subjects make an informed decision before enrollment.
The answer is consistent with GCP guidelines which mandate that the ICF clearly outlines the risks and benefits of participation to protect participant rights.
"The ICF should include a clear explanation of potential risks and benefits to ensure informed decision- making by the participant." Objectives:
* Ensure informed decision-making by potential subjects.
* Provide transparent risk-benefit information.
NEW QUESTION # 43
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