SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Study participants

Responsible for covering insurance

Sponsor

Insurance fee: A minimum coverage sum is defined

Yes

Minimum coverage sum

The defined policy values for liability coverage are at least: Cat A trials:
Entire trial: CHF 3 000 000.-
Per person: CHF 250 000.-
All other clinical trials: Entire trial: CHF 10 000 000.-
Per person: CHF 1 000 000.-

Applicable national legal framework/ Reference

19 (1) HRA;
Art 13, Annex 2 and 14 KlinV/ClinO

Additional Information

The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial (extension of this period is attributable to the use of ionising radiation and GMOs (Art. 11 KlinV/ClinO).

Exemptions from liability coverage requirements in relation to clinical trials are attributable in special cases such as low- risk Cat A trials, pursuant to Art.12 KlinV/ClinO.
The insurance certificate needs to be sent to the EC.
The General Insurance Conditions (GIC) and a master Certificate of Insurance is provided on the Swissethics website in section Templates > Insurance.

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