In order to support response efforts to this pandemic, the FDA has issued guidance to provide non-binding recommendations regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions. Learn more about these recommendations intended to assist IRBs in complying with the requirements in 21 CFR Part 56.
View the complete guidance document
CITI Program’s FDA Inspections Course
FDA Inspections: From Site Preparation to Response prepares investigators and sites for an FDA Bioresearch Monitoring Program (BIMO) inspection by reviewing the concrete steps to take before, during, and after the inspection.
- Describes the FDA inspection process of clinical investigators and sites.
- Identifies how to prepare for an inspection.
- Discusses the investigator and site’s conduct and responsibilities during and after an inspection.
- Describes how to respond to different FDA classifications including Official Action Indicated (OAI) findings following an inspection.
- Reviews strategies for long-term success with CAPA plans.
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