ECSafetyReporting object

Reportable AEs

SAE + SADE occurring in a Cat. C clinical trial in Switzerland

Responsible for AE reporting to relevant EC(s)

Investigator

SAE/SADE must be reported

Immediately (without delay)
Within a max of 2d upon first knowledge
Within a max of 7d upon first knowledge

National Standard Reporting form available

Via web portal BASEC (mandatory to use from 1st January 2016)

Preferred reporting format

Online portal

Online Safety Reporting Portal

Starting from November 2nd 2015 all new projects should be submitted through the web-portal. As of January 1st 2016 the online-submission is mandatory and replaces all former submission methods (paper, CD, other storage devices). Please use the former submission methods for amendments and additions to old projects until December 31 2015; from January 1st 2016 the web-portal will also be compulsory for old projects.

Provision of Annual safety report mandatory

Yes

Applicable national legal framework/ Reference

Art. 42 KlinV/ClinO

Additional Information

SAE/ SADE must be declared within:
- 7 days if it cannot excluded that the events are attributable to the MD or a trial-related intervention
- 2 days if the safety of study participants is at stake.

In multi-centre trials, the Coordinating Investigator shall also notify all responsible ECs concerned.

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