Safety reporting

You should be able to define the following:

• adverse events (AE)
• adverse reactions (AR)
• serious adverse events (SAE)
• serious adverse reactions (SAR)
• suspected unexpected serious adverse reactions (SUSAR)

For details please see:

University Core SOP 3: Safety reporting for CTIMPs

This procedure must be followed for CTIMPs, but may also be used for clinical research studies.

If you require more specific detail you can prepare an additional departmental SOP.

Staff in the Research Governance, Ethics & Assurance Team are happy to provide basic training on safety reporting, but it is your responsibility to ensure that you fully understand this matter.

Responsibility for reporting

Overall responsibility for reporting lies with the sponsor. However, accountability may be delegated to the chief investigator, who will have specialist knowledge of the disease area and the medicinal product being investigated.  

On behalf of the University, staff in the Research Governance, Ethics & Assurance Team will undertake a risk assessment to assess the level of delegation. If a committee is in place to review SAEs, then responsibility may be delegated. 

The Research Governance, Ethics & Assurance Team will always require a copy of any development safety update reports (DSURs) submissions produced for CTIMPs. Please send to RGEA.Reports@admin.ox.ac.uk

Serious adverse event form and guidance

Serious Adverse Event Form Template (updated 2024)

Guidance for customising the template SAE report form (updated 2024)

SAE reporting form completion guidelines (updated 2024)

Suspected unexpected serious adverse reactions

SUSARs should be reported electronically to the MHRA.
 

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).