ECSafetyReporting object

Reportable AEs

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

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (not later than 24h)
Followed by detailed written report within 5d

Responsible for AE reporting to relevant EC(s)

Sponsor

SUSAR being life-thereatening or leading to death must be reported

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

All other SUSAR must be reported

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory

Yes

Applicable national legal framework/ Reference

Art 22 Law 21/2014 (pt), as amended by law 73/2015

Additional Information

Trials not submitted through RNEC (before January 2016):
On-line: Format ICH E2B/EudraVigilance
CIOMS Form to email: farmacovigilancia.ec@infarmed.pt
Trials submitted through RNEC (after January 2016):
DSURs submitted through RNEC

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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