SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Sponsor
Study participants
Hospital/ trial center

Responsible for covering insurance

Sponsor

Minimum coverage sum

The required compensation sum is: • Minimum 250000 € per patient as flat sum or 25000 € per patient/year) • Maximum 2500000 € for the whole study/ year

Applicable national legal framework/ Reference

Royal Decree 1090/2015

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