SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Study participants

Responsible for covering insurance

Sponsor

Insurance fee: A minimum coverage sum is defined

Yes

Minimum coverage sum

500,000 EURO

Applicable national legal framework/ Reference

Section 40 (subsection 1, sentence 3 No. 8) AMG
Section 40 (subsection 3) AMG

Additional Information

Pursuant to section 40 subsection 1 sentence 3 No. 8 AMG, an insurance has to be contracted.
This insurance must be taken out in favour of the participant in a clinical trial with an insurance carrier authorised to conduct business in a Member State of the European Union or another State which is a member of the EEA (European Economic Area). Its scope must be reasonably commensurate with the risks involved in the clinical trial and determined on the basis of the risk assessment in such a way as to ensure that in case of the death or permanent disability of a participant, at least 500,000 EURO will be available (section 40 subsection 3 AMG).

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