Scope
Clinical Trial Insurance covers the civil liability of the Insureds for losses arising from carrying out the clinical trial stated in the insurance policy.
This wording complies with the Ordinance of Ministry of Finance from 18 May 2005 amending the Ordinance of Ministry of Finance from 30 April 2004 on Compulsory Liability Insurance of Researcher and Sponsor.
We have arranged polices for clinical trials run in Europe including non-EU countries like Ukraine etc.
Although the compulsory insurance is arranged, the participant still carries a significant risk of participating in the study.
Therefore, we recommend to our clients to additionally arrange a non-fault liabillity insurance, which provides insurance coverage in the event of damages for which the investigator or sponsor is not culpable. In this insurance, the participant is entitled to compensation as a result of his injury or damage to his health in connection with the study, and the insurer may not refuse to pay compensation, calling that the Insured`s was dilligent or the participant consented to the risk of adverse effects by signing the ICF.
Legal basis
a) Ordinance of Ministry of Finance from 18 May 2005 amending the Ordinance of Ministry of Finance from 30 April 2004 on Compulsory Liability Insurance of Researcher and Sponsor
b) Act of May 22, 2003 on compulsory insurance, Insurance Guarantee Fund and Polish Motor Insurers’ Bureau
c) Compulsory Liability Insurance of Sponsor and Investigator Terms & Conditions
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