SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Study participants

Responsible for covering insurance

Sponsor

Applicable national legal framework/ Reference

Prior to the commencement of a clinical trial, the sponsor is obliged to contract insurance for study subjects in the event of health damage caused by the clinical trial (according to Art 72 Law on MP & MD 2010 and Art 6 (18) of Rulebook Application 2011).

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
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