Adverse Events (AEs) and Serious Adverse Events (SAEs) Guidelines (PDF, 152K) describe requirements and processes for reporting adverse events and unanticipated problems to the study's safety monitoring bodies. It incorporates guidelines provided by the Office of Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS) and describes Food and Drug Administration (FDA) reporting requirements.
- Adverse Event Form (MS Word, 38K or screen-readable PDF, 69K) provides a template for a study form for collecting information about adverse events that is reviewed by safety monitoring bodies.
- Serious Adverse Event Form (MS Word, 31K or screen-readable PDF, 769K) provides a template for a study form for collecting information about serious adverse events. The form includes major components of the Food and Drug Administration (FDA) Form 3500.
- AE/SAE Process Flow (MS Word, 79K or screen-readable plain text file, 4K) illustrates how adverse events and serious adverse events are handled within a study.