Скачать или смотреть FDA Clinical Investigator Training Course 2024: Clinical Investigator Inspection Readiness

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Michelle Anantha presents on clinical investigator inspection readiness, offering practical guidance for navigating FDA inspections. She explains that the FDA evaluates clinical trial conduct for compliance with regulations and Good Clinical Practice (GCP), ensuring participant safety, welfare, and the reliability of submitted data. Inspections encompass two main types: routine/surveillance, conducted for pre-marketing reviews or general compliance, and for-cause, initiated to investigate allegations of potential violations. Anantha details the inspection sequence, which typically involves a pre-announcement, issuance of Form FDA 482 for domestic inspections, an opening meeting, review of paper and electronic records, interviews, and site walkthroughs. She clarifies that a Form FDA 483 summarizes observed conditions but does not necessarily constitute a regulatory violation; the center makes that determination. Clinical investigators have the option to submit a written response to a 483, providing corrective and preventive action plans (CAPA) and supporting documentation, which can influence the final compliance decision. FDA inspections are ultimately classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI), with OAI representing serious noncompliance that may lead to enforcement actions like warning letters or disqualification proceedings. Case examples illustrate how protocol deviations, such as exceeding pediatric dosing or unblinding assessors, result in OAI classifications due to compromised subject safety or data integrity. Anantha concludes by emphasizing that always being prepared is the best way to successfully navigate an FDA inspection.