Safety reporting

researchers looking at a battery

All adverse events must be reported to the HOD and RGI team 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 [PDF]‌ describes the ethics application process from the routes to ethics review to PI responsibilities after approvals are in place.

(Please note this document does not currently meet accessibility requirements, please email the Ethics and research governance coordinator for an accessible version. If you have any questions please contact a member of the RGIT.)

Safety Reporting

This ICREC-SETREC Safety Reporting SOP [PDF]‌ 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 [Word]‌ to the Ethics and Research Governance Coordinator within 24 hours of the PI becoming aware of the event.

Reporting of protocol violation or deviation

The Principal Investigator should report any protocol violation or deviation. Please send the Protocol Violation and Deviation Form [Word]‌ to the Ethics and Research Governance Coordinator within 24 hours of the PI becoming aware of the event.‌