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NEW QUESTION # 100
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:
Answer: B
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 # 101
Who is responsible for the ongoing safety evaluation of the IP?
Answer: D
Explanation:
The sponsor is primarily responsible for the ongoing safety evaluation of the investigational product (IP) throughout the clinical trial. This responsibility includes monitoring adverse events, reporting serious adverse events (SAEs) to regulatory authorities, and updating the Investigator's Brochure (IB) with relevant safety data.
According to GCP guidelines, the sponsor must continuously evaluate safety data and report findings to regulatory bodies as necessary.
"The sponsor is responsible for the continuous safety monitoring of the investigational product and for ensuring that new safety information is communicated to investigators and regulators." Objectives:
* Ensure participant safety throughout the study.
* Maintain accurate and timely reporting of safety data.
NEW QUESTION # 102
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?
Answer: A
Explanation:
In this situation, the correct course of action is to request the DSMB to conduct a thorough risk assessment and provide recommendations on unblinding the affected sub-group.
* Reasoning:
* The trial protocol specifies that unblinding should only occur if a life-threatening situation arises.
Since the observed hepatotoxicity, although severe, does not automatically qualify as life- threatening, it is prudent to proceed cautiously.
* Immediate unblinding of the entire trial (Option A) would compromise the study's integrity and could introduce bias.
* Submitting the DSMB findings to the IRB/IEC (Option B) without first conducting a more thorough risk assessment may delay necessary safety measures.
* Conducting a protocol amendment (Option C) without a comprehensive risk assessment may be premature.
* Role of the DSMB:
* The DSMB is responsible for evaluating safety data and making independent recommendations to protect trial participants. In this case, the DSMB should analyze the risk/benefit ratio of continuing the trial with the current protocol versus implementing safety modifications.
* Ethical Considerations:
* Protecting patient safety is paramount, but any unblinding must be justified by a clear and imminent risk. The DSMB's independent judgment is critical to making this decision without sponsor influence.
Verified Answer from Official Source:
According to GCP guidelines, any decision to unblind a study must be based on a comprehensive safety assessment, and the DSMB plays a key role in making unbiased recommendations regarding unblinding.
Exact Extract:
"Unblinding in a clinical trial should only occur when justified by critical safety concerns, as recommended by an independent data monitoring committee." Objectives:
* Maintain trial integrity while safeguarding patient safety.
* Follow protocol and regulatory requirements for unblinding.
* Ensure independent decision-making by the DSMB to avoid sponsor bias.
NEW QUESTION # 103
A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?
Answer: B
Explanation:
A Corrective and Preventive Action (CAPA) plan is implemented to address deviations and prevent them from recurring. In this context, the purpose of the CAPA is to establish a procedure for the Principal Investigator (PI) to ensure proper oversight of protocol deviations. This ensures that all future deviations are appropriately managed, reviewed, and documented according to GCP standards.
The answer is verified from GCP guidelines which emphasize that CAPA should focus on identifying root causes and establishing processes to prevent future deviations.
"A CAPA plan must address the root cause and implement systematic actions to prevent the recurrence of protocol deviations." Objectives:
* Ensuring PI oversight in protocol adherence
* Maintaining data integrity through systematic corrective actions
NEW QUESTION # 104
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
Answer: D
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 # 105
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