What is a serious and/or unexpected adverse event?
A serious adverse event is any event that results in death, life threatening experiences, hospitalizations or prolongation of hospitalization, disability or incapacitation, overdose, congenital anomalies or other serious events that may jeopardize the participant or require medical or surgical intervention to prevent any of the outcomes listed in this definition.
Unexpected adverse events are events that are not previously known or anticipated to result from the interactions or interventions of the research or underlying condition of the human subject. The assessment of the significance and expectedness needs to account for the level of severity and frequency of the event. For example, this would include events that are expected in some subjects, but are determined to be occurring at a significantly higher frequency or severity than expected.
- Serious Adverse Event forms must be reviewed and submitted by the Principal Investigator using the SAE form.
- Report all serious and/or unexpected adverse events (according to the rules below) using the SAE reporting form as soon as possible, but no later than 5 days after the research team learns of the event.
- Any event that is judged by the PI as likely to have a significant impact on the safety and welfare of other study participants should be reported immediately.
- A summary of reported adverse events and DSMB summary reports must be submitted at the time of continuing review.
- The principal investigator is responsible for providing information about the serious adverse event to to the study sponsor, funding agency, and FDA when appropriate.