What are my obligations in relation to reporting serious adverse events or reactions?
Establishments are required to submit reports of serious adverse events (SAEs) or serious adverse reactions (SARs) ‘without delay’. Establishments should take note that a full investigation of an event or reaction is not required for submitting an initial report. The results of a root cause analysis and corrective preventative actions can be submitted as a follow-up report at a later date. It is the responsibility of the Designated Individual (DI) to notify the HTA of any suspected SAE or SAR. In the DI’s absence this responsibility can be delegated to other designated members of staff (this process should be supported by a clearly documented procedure outlining such delegated responsibilities). If you are a third party providing services to a licensed establishment, or if you purchase material from a licensed establishment, then you should report SAEs and SARs directly to the DI of the establishment you are working with. You should advise the DI that they need to report to the HTA on
