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ACRP Certified Professional Exam Sample Questions (Q103-Q108):

NEW QUESTION # 103
In a quality management system, in which category do risk reduction activities belong?

A. Risk Evaluation
B. Risk Review
C. Risk Control
D. Risk Communication

Answer: C

Explanation:
Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.
GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.
"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase." Objectives:
* Implement effective risk management strategies.
* Ensure proactive risk mitigation in clinical trials.

NEW QUESTION # 104
Which strategy is used to safeguard subject privacy?

A. Store source documentation in the CRC's office.
B. Conduct subject-related conversations in controlled environments.
C. Email updated enrollment logs to the CRA.
D. Utilize subject initials on correspondence.

Answer: B

Explanation:
Conducting subject-related conversations in controlled environments ensures that personal and sensitive information is not overheard or disclosed to unauthorized individuals. This practice upholds patient confidentiality as required by GCP and data protection regulations.
The answer follows GCP guidelines for protecting the privacy and confidentiality of clinical trial participants.
"Conversations regarding study subjects should be held in secure and controlled environments to protect personal data." Objectives:
* Ensuring confidentiality in clinical trial settings.
* Protecting patient privacy according to ethical standards.

NEW QUESTION # 105
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. Study sponsor
B. Investigator at each site
C. Original reporting investigator
D. Regulatory authority

Answer: A

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 # 106
Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

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

Answer: A

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 # 107
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. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
B. Update the IB to add the risk of infection and submit to the sponsor for approval.
C. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

Answer: C

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 # 108
......

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ACRP Certified Professional Exam Sample Questions (Q103-Q108):

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