Privacy notice for Serious Adverse Reaction/Event Report Form – Human Tissues and Cells 

The HPRA operates the national system for recording and reporting details of suspected adverse reactions occurring in Ireland. Please see full details of how personal data is processed in this area.

Tissues and Cells Adverse Reaction/ Event Report Form

Fields marked with an asterisk (*) are mandatory.

To move through the steps of the form please use the Next and Previous buttons that are at the bottom of the form.

  • Please do not include any information that would identify the patient, healthcare professional, or other individuals involved. Donor, recipient and staff names (other than the reporter), are not required, and this information should be anonymised.
  • Additional information may be provided in attachments, please ensure that the identification number is included on any attachments.
  • A Guide to Reporting Serious Adverse Reactions and Serious Adverse Events Associated with Human Tissues and Cells is available here
  • Reporter Information
  • SAE/SAR Details
  • Implicated Tissue/Cells
  • Details and Categorisation
  • Photos & Files
  • Preview & Submit
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Reporter Information