CASafetyReporting object

Sponsor

National CA
EMA Eudravigilance CT Module (EVCTM)
NB: In parallel to both!

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

As soon as possible
Within a max of 7d upon first knowledge (+ 8d for additional information)

As soon as possible
Within a max of 15d upon first knowledge

A standard online form for investigator-led trials is available on the HPRA website in section: Medicines > Regulatory Information > Clinical trials > Reporting Serious Adverse Events .

Electronically

SUSAR reporting requirements are in accordance with the ‘Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use, CT-3’, and the requirements specified in the HPRA ‘Guide to Electronic Submission of ICSRs and SUSARs Associated with the Use of Human Medicines’ (available on the HPRA website in section: Reporting Serious Adverse Events).

Detailed guidance on the notification of adverse events, submission of DSURs and other safety related events, are described in the HPRA Guide to Clinical Trial Applications, which is available on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications.
The guidance is based on standard EU safety reporting requirements, as described in the European Commission’s guidance CT-3.

Sponsor

Immediately