ECSafetyReporting object

Adverse Events (AE) - Definitions (pursuant to national law)

AE of IMP is defined in the Art.3 of the Pharmaceutical Law 2001.
SAE of IMP is defined in the Art. 3c) and 3d) of the Pharmaceutical Law 2001.

Reportable AEs

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

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (without delay)

Responsible for AE reporting to relevant EC(s)

Sponsor

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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