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If your research is not a CTIMP, you should refer to the safety reporting for research other than CTIMPs page.
European Commission guidance
Suspected unexpected serious adverse reactions (SUSARs)
Reports to be sent to the REC
Submitting safety reports to the REC
NRES generally follows the guidance from the Medicines and Healthcare products Regulatory Authority (MHRA) in relation to safety reporting requirements for UK trials.
The document below sets out an overview of the safety reporting process:
If you are the sponsor of a CTIMP taking place in the UK, you should also refer to the document below, regarding suspected unexpected serious adverse reactions (SUSARs):
There are separate, non-statutory requirements for the submission of annual progress reports to NHS RECs.
You can find more information about safety reports in section 9 of the