Rules of Reporting
The principal investigator must complete the SAE form for all serious and/or unexpected adverse events when the New York State Psychiatric Institute IRB reviewed the protocol and approved enrollment at the site of the adverse event.
All reports are reviewed by the IRB monitor, the IRB Chair or Vice Chair, or the Full Board, depending on the nature of the event and the perceived impact on study risks or benefits. The Full Board receives a periodic summary of all adverse event reports. This information is considered a central part of the continuing review process.
During initial review by the monitor or chairs, we will determine that:
- No further action on your part is indicated,
- Additional information or analysis is required before a determination can be made,
- Review of the event by a convened meeting of the IRB is required.
You will notified of all determinations and actions.