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Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
A. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B. A monitoring report that identifies deviation from the approved protocol.
C. Training records of site personnel on study protocol, and their study-related duties and functions.
D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
Answer: C
NEW QUESTION # 44
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. 3.0 mg/dL
B. 3.6 mg/dL
C. 2.6 mg/dL
D. 1.8 mg/dL
Answer: A
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 # 45
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?
A. Meet with the site staff to understand their workflows and to review retention strategies.
B. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
C. Require participants to provide documented reason for withdrawal.
D. Interview participants who have dropped out.
Answer: A
Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.
NEW QUESTION # 46
Which document confirms the PI's agreement to permit auditing at the study site?
A. Protocol
B. ICF
C. IB
D. Delegation Log
Answer: B
Explanation:
The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.
This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.
"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes." Objectives:
* Ensure informed consent for data access.
* Facilitate compliance with auditing requirements.
NEW QUESTION # 47
Which of the following elements of the Informed Consent are NOT required?
A. Subject legal rights can be waived
B. Statement that study involves research
C. A description of any reasonably foreseeable risks or discomforts
D. A description of potential benefits
Answer: A
Explanation:
Informed consent must not include any language that implies a waiver of the participant's legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant's legal rights or releases the sponsor or investigator from liability." Objectives:
* Protect participant rights in clinical trials.
* Ensure that consent is given voluntarily and ethically.
NEW QUESTION # 48
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