Reporting Events on FDA Regulated Studies

• FDA website: “What is a Serious Adverse Event?”
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
• Policy: Policy 500, Research Involving Drugs, Biological, and Nutritional Products, Section E.2.a.VII Sponsor Responsibilities
• Link to IND Safety Report Submissions FAQs