Safety/adverse event reporting

A serious Adverse Event (SAE) is defined by the National Research Ethics Service (NRES) as:

An untoward occurrence that:
 

• results in death,
• is life-threatening,
• requires hospitalisation or prolongation of existing hospitalisation,
• results in persistent or significant disability or incapacity,
• consists of a congenital anomaly or birth defect, or
• is otherwise considered medically significant by the investigator.

All SAEs which occur in any interventional study within the following Trusts must be reported within 15 days to the R&D office at NHS Norfolk.

• NHS Norfolk
• Norfolk Community Health & Care
• NHS Suffolk
• Suffolk Community Healthcare
• Great Yarmouth & Waveney Community Services

All reports must contain:

• Study Details (Ref / Title / Chief Investigator / Local PI)
• Host Organisation
• Type of event
• Details of event
• Outcome (if known) – a supplementary report may need to be supplied
• An assessment as to whether the SAE was, in the opinion of the Investigator:
  • ‘related’: that is, it resulted from administration of any of the research procedures; and
  • ‘unexpected’: that is, the type of event is not listed in the protocol as an expected occurrence.

This is in addition to any reporting requirements to the Research Ethics Committee (REC), MHRA and Study Sponsor.

As long as the above information is supplied the R&D office will accept submission of either the REC SAE report form or any Sponsor derived report form.

For further information please contact the R&D office at NHS Norfolk.