Internal Adverse Events
An adverse event (AE) is any untoward or unfavorable occurrence in a human subject (e.g., physical, psychological, social, legal, or economic harm) temporally associated with the subject’s participation in the research (whether or not related to participation in the research). This means the AE may be expected or unexpected, and related or unrelated to the subject’s participation in the research. Most AEs involve physical harm.
The IRB only requires submission of internal AE reports when the event is unexpected and related/possibly related to the research. Internal adverse events occurring on a study which satisfy these criteria must be submitted to the IRB within 2 business days following the time it becomes known. Any death, which occurs while the subject is being treated on protocol or occurs within 30 days of completing research related interventions, must be reported immediately if it meets the reporting criteria.
Internal AEs get submitted through the RSS system.
External Adverse Events
The RSS system will no longer accept external AE reports. As a result of FDA Guidance, the IRB no longer requires submission of external AE reports for drug studies unless the PI and/or the sponsor determines that a change in protocol or a revision of the consent document is necessary upon analysis of the external AE report.
For those external AEs that require a change in protocol or revision of the consent document, the external AE report (i.e., IND Safety Report) received by the PI from the sponsor, should be submitted to the IRB with a Request for Change form along with the revised IRB Application and consent form(s).
External Adverse Events for device studies must be reported to the IRB (in no case no later than 5 business days following PI notification from the sponsor that the event occurred) in accordance the requirements of 21 CFR 812.150(b)(1).
The PI should submit the report received from the sponsor along with any required Request for Change.
Once the status of a study is changed to “completed,” the IRB will no longer accept external UADE reports except under circumstances where the report involves important new risk information.