SSInsurance object
Investigator(s)
Sponsor
Study participants
Sponsor
Yes
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€
Yes
• 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