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Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
A. CRC
B. CRO
C. Sponsor
D. Investigator
Answer: C
Explanation:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.
NEW QUESTION # 116
IP is dispensed to all subjects who:
A. Are eligible to receive it in the trial.
B. Screened for the trial.
C. Consented for the trial.
D. Need IP for their medical condition.
Answer: A
Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.
NEW QUESTION # 117
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:
A. A total of five members.
B. One member whose primary area of interest is in the same scientific area.
C. One member of the site's QA group.
D. One member who is independent of the institution/trial site.
Answer: D
Explanation:
The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.
This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.
"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective." Objectives:
* Maintain impartiality in ethical review.
* Ensure diverse representation within the IRB/IEC.
NEW QUESTION # 118
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?
A. To escalate corrective actions to the regulatory authority
B. To establish a procedure for PI oversight of protocol deviations
C. To determine if a protocol amendment is needed
D. To determine if the deviations invalidate the data
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 # 119
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
A. 2.6 mg/dL
B. 3.6 mg/dL
C. 1.8 mg/dL
D. 3.0 mg/dL
Answer: D
Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.
NEW QUESTION # 120
......
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