FOR PATIENTS

FOR PATIENTS

A rich collection of information that every patient should be familiar with.

INSURANCE

Compulsory insurance

Polish law absolutely requires that every participant taking part in a clinical trial has to be insured against the negative effects of taking the test substance. This is included in the Ordinance of the Minister of Finance of 30 April 2004 on compulsory third party liability insurance for the researcher and the Sponsor, as amended.

As the manufacturer of the drug assumes responsibility for any negative effects of his actions not included in the “Product Characteristics / see the” what is a drug “tab, so the sponsor – producer of the tested substance is responsible for its operation.

A prerequisite for registration of the study in Poland / see the tabs “STAGES OF CLINICAL TRIALS” and “INSTITUTIONS SUPERVISING CLINICAL TRIALS” / is the presentation in the CEBK of the so-called “Sponsor and researcher policy”, bought out in an insurance company by the sponsor, which strictly determines the number of insured participants in the study in Poland. This may be the reason for not being able to include another participant in the study.

A copy of this policy is located in each research center. Each participant of the study may become familiar with its content.

Optional Insurance

Each physician, including, of course, a doctor conducting clinical treatment or research, must purchase an insurance policy covering potential claims / costs of treatment, costs of compensation of patients who, as a result of their incorrect decisions during treatment, have suffered damage to their health. Because, according to Polish law, clinical trials are not treating the patient, because they are not using a medical drug / see the “what is a drug?” tab, but just the test substance; this insurance is limited in the course of a clinical trial.

Therefore, our center has a special third party policy, covering the same scope as policies regarding medical activity, but operating in the field of clinical trials.

CONTACT FORM FOR PATIENTS



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