ECSafetyReporting object

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

AE and ARs: see 2a AMG

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
Legal representative domiciled in the EU/EEA

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

As soon as possible
Within a max of 7d upon first knowledge

All other SUSAR must be reported

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

Sponsor is obliged to notify all investigators of SAE/ SADE occurrence

Yes

National Standard Reporting form available

Yes

Standard Reporting Form

"Meldungsformular" (available only in German: Form to be used for notification of amendments, AEs, and other nofitications to Austrian ECs)

Reporting format - Options

Email
Online portal
Regular mail
Fax
Other

Preferred reporting format

Other

Provision of Annual safety report mandatory

Yes

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

Guideline - Safety Reports to Austrian ECs (en)/ Leitlinien für Sicherheitsmeldungen (de)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 41e AMG

Additional Information

1. Recipients of reports: a) Multicentre trials: the Lead EC b) Singlecentre trials: the responsible local EC
2. Guidance on AE reporting, submission of annual safety report and the standard reporting form is available on the website of the Forum Österreichischer Ethikkommissionen in section: Formulare, Leitlinien, Informationen, Gesetze, etc. > Meldungen

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