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
No
Applicable national legal framework/ Reference
Art 72 Law on MP & MD 2010
Art 6 (18) of Rulebook Application 2011
Additional Information
Prior to the commencement of a clinical trial, the sponsor is obliged to contract insurance in the event of health damage caused by the clinical trial.
Insurance is mandatory in all interventional investigations on MD and registries.
