Ransomware attack: HPRA guidance & SAE reporting

HPRA Guidance

The HPRA has published guidance (v1.0 dated 25th June 2021) for clinical trials in response to the HSE cyber attack:

SAE reporting

Notice to clinical trial hospital sites affected by the HSE ransomware attack

Please note that Serious Adverse Event (SAE) reporting on our clinical trials can be done by any of the following methods if you are unable to send by email:

  • Fax to 01-6697869
  • Telephone/text pharmacovigilance on 086-0459782
  • Telephone main phone line on 01-6677211

Please include your name/telephone number on any communications so that Pharmacovigilance can contact you for further information if needed.