Скачать или смотреть FDA CITC 2024: Investigator Responsibilities: Expectations for the Conduct of Clinical Trials

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Miah Jung presents on the critical responsibilities of clinical investigators in clinical trials, highlighting their central role in driving medical innovation while ensuring participant safety, data integrity, and compliance with FDA regulations and Good Clinical Practice (GCP) standards. Expanding on Cheryl Grandinetti’s earlier message, Jung emphasizes fit-for-purpose clinical trial quality and risk proportionality, urging investigators to focus resources and oversight on critical data points and high-risk areas, adapting practices as new challenges arise. She details the commitments investigators make by signing the FDA Form 1572, which include adhering to the approved protocol, ensuring appropriate informed consent, and securing IRB review. Jung stresses the investigator’s ultimate responsibility for supervising the entire trial, including delegated activities, ensuring qualified staff and appropriate training. Key responsibilities extend to meticulous data management, ensuring data integrity (complete, consistent, accurate) and timely access to records, with the investigator accountable for record-keeping and retention, even for remotely collected electronic data. Prompt identification and reporting of adverse events to sponsors or IRBs are also crucial. Finally, Jung discusses ClinicalTrials.gov requirements, clarifying that while sponsors are generally the responsible party, clinical investigators may be designated, necessitating their understanding of registration and results reporting for applicable clinical trials.