Human Tissue Authority

The regulator for human tissue and organs

Serious Adverse Event or Reaction (SAEARs)

Human application adverse event and reaction reporting

The HTA has an online system, via the secure web Portal for the reporting of any serious adverse events and / or reactions that are linked to the procurement, testing, processing, storage and distribution of human tissues and cells for human application. More information about human application adverse event and reaction reporting, including guidance on reporting and links to the HTA portal. Further information about how the HTA plans to disclose information about HTARIs and SAEARs can be found here.

Organ donation and transplantation adverse event and reaction reporting

As of the 27 August 2012 HTA-licensed establishments in the organ donation and transplantation sector are required to report any serious adverse events and reactions to NHSBT, who will be managing the system on behalf of the HTA. Further information and the online system can be accessed here:

  1. Guidance for reporting SAEARs in the ODT sector (updated August 2015)
  2. NHSBT incident submission form (link is external)
  3. Reporting an ODT SAEAR to NHSBT 
  4. How the HTA plans to disclose information about HTARIs and SAEARs

If you have any further questions, contact us.

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