IND safety reporting is a core function of clinical trials. Study sites and sponsors are responsible for reporting adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), suspected unexpected serious adverse reactions (SUSARs), unanticipated problems (UPs), and unanticipated adverse device effects (UADEs) according to detailed instructions of FDA guidances. This webinar describes what is reported, to whom, and according to what timelines. It explains the criteria for determining causality and discusses the actions that sponsors must take when identifying significant risks to study populations.
Release Date: March 20, 2025
Language Availability: English
Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Investigators, Sponsors, Students
Organizational Subscription Price: Included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person
