CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
Regional CA
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)
All investigators

Reportable AEs

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

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 SUSARs

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

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

Guidance on AE reporting procedure

Detailed information about Pharmacovigilance issues including SAE and SUSAR reporting are provided on the BfArM website.

Applicable national legal framework/ Reference

Sections 12 and 13 GCP-V

Additional Information

Annual Safety report shall include a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects’ safety.
Format: DSUR (Development Safety Update Reports). Guidance available on BfArm website in section: Medicinal Products > Licensing > Clinical Trials.

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