Safety Reporting Process

The process for safety reporting varies depending on whether or not the research is a ctIMP and on the procedures of the Sponsor of the research.

This general process should be followed in all research:

  • RECORD the event may be recorded on the patient's medical notes, a Case Report Form (CRF) or on a Safety Reporting Form provided by the Sponsor.
  • ASSESS an assessment should be undertaken by the Chief or Principal Investigator to evaluate seriousness, causality, intensity and expectedness. 
  • REPORT based on the conclusion from the previous step, the event should be reported on the CRF and/or SAE form as appropriate and within the timescales required.

There are a number of other issues to consider at each stage and the timescales depend on the nature of the event – for example a fatal Suspected Unexpected Serious Adverse Reactions (SUSAR) must be reported and signed by the PI within 24 hours to the Sponsor, followed up in writing within 48 hours, and reported to the MHRA and REC no later than 7 days after the Sponsor becomes aware of the reaction.

View Our Research

Doctor conducting research at NBT

Explore the ground-breaking research currently taking place at North Bristol NHS Trust.

About Research & Development

NBT Researcher

Find out more about our research and how we're working to improve patient care.

Contact Research

Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Bristol, BS10 5NB

Telephone: 0117 4149330