ECSafetyReporting object

Reportable AEs

SAE + SUSARs from Luxembourg trial sites

Investigator shall report SAE to

Sponsor + EC (all SAEs having lead to death)

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

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

Yes

National Standard Reporting form available

Reporting format - Options

Preferred reporting format

Provision of Annual safety report mandatory

Yes

Guidance on AE reporting procedure

All documents to be sent electronically to: contact(at)cner.lu
Annual study report (regarding study progress and safety aspects: Modèle rapport annual CNER (template available).

Related information is available on CNER/NREC website in section Procedures > Follow-up procedures

Applicable national legal framework/ Reference

Art 15 & 16 modified RGD 30 May 2005

Additional Information

If clinical trial on experimental medicine (other required documents):
• 6-monthly SUSARs line listing
• DSUR

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