Safety reporting

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

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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:

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.

CTRG staff 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, CTRG staff 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. CTRG will however 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 NHS Trust and the University. CTRG must be notified of SAEs within 24 hours.

Serious adverse events

Use the serious adverse events reporting form for CTIMPs and return it to CTRG:

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).
 

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