CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Reportable AEs

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

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

Immediately (without delay)
Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSARs

Immediately (without delay)
Within a max of 15d upon first knowledge

National standard reporting form available

Only for reportable events occurring in the respective country

Standard Reporting Form

Electronic form available on the SUKL website (in Czech language only)

Reporting format - Options

Electronically

Annual safety report shall be provided by sponsor to

National CA

Guidance on AE reporting procedure

“KLH-21 -Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation” (available on SUKL website).
http://www.sukl.eu/medicines/klh-21-version-5

Applicable national legal framework/ Reference

Act on Pharmaceuticals (No. 378/2007)
Decree on GCP (No. 226/2008)

Additional Information

The Annual Safety Report has to be submitted electronically to the CA (klinsekret(at)sukl.cz).

The sponsor will provide a report for the EudraVigilance database. Those sponsors who do not have access to the electronic exchange of SUSARs with the EudraVigilance database and SUKL – i.e. particularly the sponsors of grant clinical trials not backed by pharmaceutical companies, i.e. the grant studies presented by physicians or professional societies, can request SUKL in a written request to make input into the EudraVigilance database on their behalf.
Reporting format to EudraVigilance Database: online

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