Safety reporting

Safety reporting is an essential aspect of Clinical Research. It is important to understand the issues involved and the legal requirements for this. You must be able to readily define, recognise and know the reporting requirements.

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)

The R&D team are happy to provide basic training on safety reporting, but it is your responsibility to ensure that you fully understand this matter.

For CTIMPs, overall responsibility for reporting lies with the Sponsor. However, accountability for this 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 OUH, the R&D 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 fully delegated. The R&D team will still require a copy of any Development Safety Update Reports (DSURs) produced for CTIMPs.

Alternatively, SAEs can be reviewed by the Trials Safety Group, a joint body of the Oxford University Hospitals and the University. In such cases the R&D team must be notified of SAEs within 24 hours of awareness of the SAE.

Serious Adverse Events (SAE)

If you need to report a Serious Adverse Event (SAE), please print, sign and email a 'Serious Adverse Events Reporting Form for CTIMPs' to R&D.

Email: ouhsae.reports@ouh.nhs.uk

OUH R&D Department - Contact us

Please refer to the 'Serious Adverse Events Reporting Form Completion Guidelines' when completing the form.

Both form and guidelines are available by emailing: ouhsae.reports@ouh.nhs.uk

Suspected Unexpected Serious Adverse Reactions (SUSAR)

SUSARs should be reported to the MHRA using the eSUSAR System:

Clinical trials for medicines: Safety reporting - SUSARs and DSURs - www.mhra.gov.uk

Clinical Research Studies

For Clinical Research Studies, a serious adverse event (SAE) occurring to a participant should be reported to the REC that gave a favourable opinion of the study where, in the opinion of the Chief Investigator, the event was 'related' (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.

Where a licensed medicine, vaccine, herbal or complementary remedy is used in a Clinical Research Study, then 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.

YellowCard - yellowcard.mhra.gov.uk

This can be used by anyone (both health professionals and the general public).