CASafetyReporting object

Responsible for AE reporting to CA

Sponsor
Legal representative domiciled in the EU/EEA

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned

Reportable AEs

SAE (Serious Adverse Event)

SAE /SADE must be reported

Immediately (without delay)

National standard reporting form available

Only for reportable events occurring in the respective country
Other

Standard Reporting Form

2 different forms available:
1. Form to be used for SAEs having occurred at an Austrian study site:
F I209 SAE (en) / F I208 SAE Klinische Pruefung MP (de)
2. Form (line listing) to be used for reporting of ALL SAEs having occurred in the clinical investigation:
F I287 SAE_Report_Table (en) / F I287 SAE EWR Meldung MP (de)
Use of European standard SAE reporting form MEDDEV 2.7/3 (or similar) is also accepted.

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

ENGLISH: L I99 Guidance CI MPG - Guidance Document for Clinical Investigations with Medical Devices (en)
GERMAN: L I192 Leitfaden KP MPG - Leitfaden für klinische Prüfung mit Medizinprodukten (de)

Applicable national legal framework/ Reference

Art 42 (8) MPG)

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