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. However, the general process below 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 step 2, the event should be reported on the CRF and/or SAE form as appropriate and within the timescales required
Is it that simple?
Yes and no. There are a number of 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.