SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Sponsor
Study participants

Responsible for covering insurance

Sponsor

Insurance fee: A minimum coverage sum is defined

Yes

Minimum coverage sum

The guaranteed insurance sums depend on the number of persons (pers) in the trial: up to 10 pers : 500 000 €/ 11-25 pers: 1 000 000 € / 26-50 pers: 2 000 000 €/ 51-100 pers: 4 000 000 €/ above 100 pers: 5 000 000€

Applicable national legal framework/ Reference

• Order of the Minister of Finance 30 Apr 2004 (Dz.U. 2004 nr 101 poz. 1034) regulating mandatory civil liability insurance of investigators and sponsors
• Order of the Minister of Finance 6 Oct 2010 (Dz.U. 2010 nr 194 poz. 1290) concerning the mandatory civil liability insurance of investigators and sponsors in clinical trials of medicinal products
• Order of the Minister of Health 10 Feb 2012 (Dz.U. 2012 poz. 207) for detailed Conditions for Determining Level of Compensation in Case of Medical Adverse Event

Additional Information

Insurance of civil liability (in Polish, „odpowiedzialność cywilna, OC“) of sponsor and investigator of a clinical trial is mandatory.
The document confirming the civil liability must be provided for the whole time of the study.

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