Safety Reporting

As a researcher working within healthcare research, 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)

Serious adverse events for non-CTIMPS

At present Lancaster University does not Sponsor CTIMP trials, however it is essential that all Serious Adverse Events (SAE) that occur in a non-CTIMP study are reported.

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

If you require any further advice on Safety Reporting get in touch with the team.