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NEW QUESTION # 90
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
Answer: C
Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.
NEW QUESTION # 91
When designing a clinical trial, why is it important to define the study population?
Answer: B
Explanation:
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.
NEW QUESTION # 92
All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:
Answer: C
Explanation:
While identifying potential risks, assessing them based on their impact, and setting risk acceptability thresholds are integral parts of a risk management approach, documenting every possible risk scenario is impractical and unnecessary. Instead, focus should be on identifying and managing the most significant and likely risks that could affect the study's quality and safety.
GCP guidelines emphasize identifying, assessing, and controlling critical risks rather than exhaustively documenting all hypothetical scenarios.
"Effective risk management involves identifying key risks, evaluating their impact, and setting control measures, rather than documenting every possible risk." Objectives:
* Implement practical and targeted risk management strategies.
* Focus on significant and likely risks rather than hypothetical ones.
NEW QUESTION # 93
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: D
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 # 94
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
Answer: C
Explanation:
The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol.
Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol's technical requirements is crucial for the trial's success.
GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.
"The investigator must have adequate resources, including access to required equipment, to perform the study as specified." Objectives:
Ensure site readiness for protocol requirements.
Prevent protocol deviations due to inadequate resources.
NEW QUESTION # 95
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