CITI Program Webinar Demo - FDA IND Safety Reporting for Clinical Trial Investigations скачать в хорошем качестве

CITI Program Webinar Demo - FDA IND Safety Reporting for Clinical Trial Investigations

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. Learning Objectives: Define key terms related to IND safety reporting. Describe FDA guidances that address IND safety reporting and possible special reporting scenarios for adverse events in clinical trials. Explain the impact of investigator reporting of adverse events on clinical trial analyses, including product causality assessments. Discuss sponsor responsibilities for clinical trial safety reporting. Presented by: Barbara Hendrickson, MD - University of Chicago For access to the full webinar, please visit: https://about.citiprogram.org/webinars/