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NEW QUESTION # 52
Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?
Answer: B
Explanation:
The sponsor is responsible for establishing written procedures to ensure that all changes or corrections in Case Report Forms (CRFs) are properly documented and justified. These procedures must include who is authorized to make changes, how corrections are documented, and how they are endorsed by the investigator.
This practice ensures data accuracy and traceability.
GCP guidelines indicate that sponsors must establish and maintain procedures for data handling and documentation to ensure accuracy and reliability.
"The sponsor should develop written procedures to ensure that CRF changes are justified, documented, and endorsed by the investigator." Objectives:
* Maintain data accuracy and consistency.
* Ensure transparent documentation practices.
NEW QUESTION # 53
SAEs must be reported immediately by the site to the:
Answer: B
Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.
NEW QUESTION # 54
When assessing the monitoring needs for a study, sponsors should:
Answer: A
Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.
NEW QUESTION # 55
When designing a clinical trial, why is it important to define the study population?
Answer: C
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 # 56
Who takes responsibility for initiating a clinical trial?
Answer: C
Explanation:
The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.
According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.
"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection." Objectives:
* Understand the sponsor's role in trial initiation.
* Ensure compliance from the outset of the study.
NEW QUESTION # 57
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