Overview
According to the law, there is already an obligation to take out liability insurance for damage to health or death of a participant in a clinical trial before the trial begins. The costs associated with the conclusion of the insurance contract are borne by the sponsor of the clinical trial. The sponsor is the natural or legal person who conducts and finances the clinical trial.
The insurance covers:
- the liability of the insured (sponsor) and the co-insured (healthcare provider, so-called performer of the clinical trial) caused by a participant in a clinical trial conducted on the territory of the Slovak Republic,
- the costs of establishing claims, the costs of defending claims for damages brought against the insured person.
The following data/documents (completed questionnaire) are required for submission of the offer:
- Copy of the protocol, a synopsis is sufficient.
- Start and end date of the clinical trial
- Number of patients participating in the clinical trial
- Clinical phase, name of the clinical trial
- Name, address and identity of the sponsor
