All adverse events must be reported to the HOD and JRCO using the Report of Serious Adverse Event Form. Full details can be found in the SOP.
ICREC SETREC Ethics Application Process SOP
This ICREC SETREC Ethics Application Process SOP describes the ethics application process from the routes to ethics review to PI responsibilities after approvals are in place.
This ICREC-SETREC Safety Reporting SOP describes the process for managing and reporting Adverse Events for Imperial College Research Ethics Committee (ICREC) and Science, Engineering and Technology Research Ethics Committee (SETREC).
Reporting of serious adverse events (SAE)
The Principal Investigator should report any SAE that is both related to the research procedure and is unexpected. Please send the Report of Serious Adverse Event Form to the Ethics and Research Governance Co-ordinator within 24 hours of the PI becoming aware of the event.