Serious adverse events
SAEs should be reported to the REC that gave a favourable opinion of the study if the chief investigator believes the event was ‘related’ (ie resulted from administration of any of the research procedures) and ‘unexpected’ in relation to those procedures.
Reports of related and unexpected SAEs should be submitted within 15 working days of the chief investigator becoming aware of the event, using the HRA safety report form for non-CTIMPs.
Yellow card scheme
If a licensed medicine, vaccine, herbal or complementary remedy is used in a clinical research study, suspected side effects (also known as adverse drug reactions) should be reported using the Yellow Card Scheme, run by the MHRA and the Commission on Human Medicines.
This can be used by anyone (both health professionals and the general public).