CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Reportable AEs

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

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 SUSARs

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

National standard reporting form available

No specific document

Reporting format - Options

Email to CA (domestic SUSARs) + Online Portal (domestic + foreign SUSARs)

Online Safety Reporting Portal

EMA EudraVigilance CT Module (EVCTM) for reporting of domestic and foreign SUSARs

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA (via e-mail AND CD) or preferably via CESP (http://cesp.hma.eu/Home)

Applicable national legal framework/ Reference

Art 16 modified RGD 30 May 2005

Additional Information

Domestic SUSARs (same protocol & other protocols with same IMP): via e-mail AND to Eudravigilance
Foreign SUSARs (same protocol & other protocols with same IMP) Eudravigilance
6 monthly SUSARs line listing: via e-mail
Email CA for safety reporting: jacqueline.genoux-hames(at)ms.etat.lu

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