Safety reporting

Guidance on the reporting of adverse events and serious adverse events (SAEs) can be found below.

ICREC SETREC Ethics Application Process SOP

The ICREC/SETREC ethics application process SOP (RGIT_SOP_44) describes the ethics application process from the routes to ethics review to PI responsibilities after approvals are in place. 

Safety Reporting

The ICREC safety reporting SOP (RGIT_SOP_45) 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.

For international non-EU CTIMP Trials, SAEs and SUSARs should be reported to the Competent Authority and Ethics Committee of the countries involved as per local reporting requirements. All SAEs should be reported to the RGIT study monitor within 24 hours after 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.‌