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 SOP describes the ethics application process from the routes to ethics review to PI responsibilities after approvals are in place.
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 to the Ethics and Research Governance Co-ordinator within 24 hours of the PI becoming aware of the event.