ECSafetyReporting object

Reportable AEs

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

Reporting timeline

Immediately (without delay)
Within a max of 24h upon first knowledge

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

Guidance on AE reporting procedure

Detailed information about Pharmacovigilance issues including SAE and SUSAR reporting (according to Sections 12 and 13 GCP-V) are provided on the BfArM website.

Applicable national legal framework/ Reference

Sections 12 and 13 GCP-V (Safety reporting obligations)
Section 13 (6) GCP-V (Annual safety report)

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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