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A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:
A. A signed clinical trial agreement between the site and sponsor is in place.
B. The site receives approval from the medical monitor to begin enrolling.
C. The DSMB meets and the first DSMB meeting report has been issued.
D. The CRA has performed source document review and verification at the site.
Answer: A
Explanation:
Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.
GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.
"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments." Objectives:
* Ensure proper contractual arrangements before trial initiation.
* Protect legal rights and obligations of involved parties.
NEW QUESTION # 45
The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?
A. The PI should notify the monitor.
B. The CRC should write a note to file.
C. The PI should amend the medical chart.
D. The CRC should amend the medical chart.
Answer: C
Explanation:
The PI is responsible for ensuring accurate documentation of adverse events (AEs) in the medical chart, including their relationship to the investigational product (IP). If an omission is identified, the PI must correct it by making a dated and signed amendment to maintain data accuracy and completeness.
GCP guidelines state that the PI must maintain accurate and complete records, including the assessment of the relationship between AEs and the IP.
"The investigator must document the assessment of the relationship between the AE and the investigational product to ensure accurate clinical records." Objectives:
* Maintain accuracy in adverse event documentation.
* Ensure data integrity through appropriate corrections.
NEW QUESTION # 46
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
A. Central monitoring of data fields by sponsor
B. Pre-qualification assessment of CRO
C. Risk-based audits of CRO activities as delegated
D. Co-monitoring of CRO site visits
Answer: C
Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.
NEW QUESTION # 47
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
A. IRB/IEC
B. Sponsor
C. PI
D. DSMB/IDMC
Answer: C
Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence." Objectives:
* Maintaining compliance and data integrity
* Addressing non-compliance proactively
NEW QUESTION # 48
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?
A. Perform a periodic review to see if the quality methods are effective and relevant.
B. Train the research coordinator on the required study assessments schedule.
C. Identify critical processes and data during protocol development.
D. Determine the quality tolerance limits for data transcription errors.
Answer: C
Explanation:
The first step in establishing a robust quality management system (QMS) is to identify critical processes and data during protocol development. This step ensures that quality objectives are clear and that monitoring and quality control efforts are focused on the most significant aspects of the study. By understanding critical data points and processes early, the sponsor can design a more effective QMS to manage risks.
GCP guidelines emphasize identifying critical data and processes at the earliest stages to develop a risk-based quality management approach.
"Identification of critical data and processes at the protocol development stage is essential for designing an effective quality management system." Objectives:
* Establish quality oversight from the start.
* Implement a risk-based monitoring approach.
NEW QUESTION # 49
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