Commercial Clinical Trials
The Stefan Cardinal Wyszyński National Institute of Cardiology – State Research Institute is one of the leading centers in the country in the implementation of cardiological and cardiothoracic clinical trials. The Institute has medical facilities and highly specialized medical staff with experience in conducting clinical trials of medicinal products and medical devices.
Between 2001-2018, around 300 clinical trials were registered at the National Institute of Cardiology. The Clinical Trials Department coordinates the trials at the center. To commence a clinical trial at the National Institute of Cardiology, a tripartite agreement must be concluded between the National Institute of Cardiology, the Sponsor (or its representative), and the Principal Investigator.
The Institute allows for the negotiation of contract terms based on the model provided by the Sponsor. The agreement is concluded in Polish or in a bilingual version. In case of disputes in the bilingual version, the Polish version prevails. To initiate discussions regarding the implementation of a clinical trial, the Sponsor sends the following study documents to the Clinical Trials Department:
- Clinical trial protocol,
- Summary of the clinical trial protocol in Polish,
- Draft agreement for conducting the clinical trial,
- Liability insurance policy for the investigator and the entity commissioning the study,
- Proposal of the total study budget per participant,
- Information on the conformity certificate (CE) of the tested medical technology (if applicable),
- For medical devices with a CE mark, confirmation of compliance of the indications in its manual with the Clinical Trial Protocol.
Additionally, to sign the agreement by the Institute’s Management, the Sponsor is obliged to provide:
- Approval from the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products for the implementation of the study,
- Ethical Committee's approval for conducting the study,
- Extract from the National Court Register or a certificate of entry into the business activity register,
- Power of attorney for persons representing the Sponsor.
In connection with conducting the negotiation process for the conditions of conducting a clinical trial, the Institute charges Sponsors a one-time administrative fee payable upon signing the agreement for the implementation of the clinical trial.