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In a quality management system, in which category do risk reduction activities belong?
A. Risk Communication
B. Risk Review
C. Risk Evaluation
D. Risk Control
Answer: D
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 # 37
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
A. A monitoring report that identifies deviation from the approved protocol.
B. Training records of site personnel on study protocol, and their study-related duties and functions.
C. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
Answer: B
NEW QUESTION # 38
Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A. Dispose of IP and request replacement from sponsor.
B. Register IP in IWRS, quarantine and notify sponsor of the excursion.
C. Register IP in IWRS and continue with subject allocation.
D. Quarantine IP without registering in IWRS and request replacement from sponsor.
Answer: B
Explanation:
If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.
GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.
"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability." Objectives:
* Maintain IP integrity and compliance with storage conditions.
* Follow protocol for managing temperature excursions.
NEW QUESTION # 39
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
A. Ensure there is an accompanying written record that describes the consent process.
B. Conduct annual reviews of the protocol and accompanying study documents.
C. Ensure submission of a data management plan to the regulatory authorities.
D. Develop a plan that describes the monitoring approach for a clinical study.
Answer: D
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 # 40
A root cause analysis should be:
A. Validated before use in a CAPA.
B. Written by the investigator.
C. Specific to a clinical trial.
D. Focused on issues of non-compliance.
Answer: D
Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.
NEW QUESTION # 41
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