For the sponsor
An entity that is interested in concluding an agreement to conduct a clinical trial is required to:
- Request preliminary approval to conduct a clinical trial from the Managing Director of Dolnośląskie Centrum Chorób Serca im. Prof. Zbigniewa Religi - Medinet Sp. z o.o. and send the relevant request to: badaniakliniczne@medinet.pl
- Pay a fee (after obtaining the approval of the Managing Director to initiate negotiations on a clinical trial agreement) for commencing negotiations on the clinical trial agreement in the amount of PLN 5,000.00 net to the bank account
- Sign a non-disclosure agreement (agreement template)
- After the Managing Director has granted preliminary approval to conduct a clinical trial, an entity that is interested in concluding a clinical trial agreement is required to download the clinical trial agreement template from the website and, after completing it, send it back to the e-mail address of the Clinical Research Centre badaniakliniczne@medinet.pl or submit its own draft agreement.
- The Sponsor/CRO is required to submit an Application, which should include the following documents:
- Draft agreement with filled in appendices
- Commitment to provide consent of the Central Bioethics Committee for conducting the study within three working days from its receipt
- Commitment to provide approval for conducting the clinical trial issued by the
- President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products within three working days of its receipt
- The study protocol, a summary of the protocol in Polish and the study procedure outline,
- An insurance policy for the clinical trial complying with the requirements of the Regulation of the Minister of Finance of 6 October 2010 on the obligatory insurance of civil liability of the sponsor and the clinical investigator in connection with the conduct of a clinical trial of devices,
- Current extract from the National Court Register or a certificate of entry in the business activity register, not older than 6 months.
- On the basis of the submitted application and preliminary budget of the study, the proposal is evaluated by the Clinical Trial Assessment Panel consisting of, among others:
- President, Chief Executive Officer
- Managing Director
- Research Consultant
- Clinical Trial Coordinator/Manager
- Pharmacist
- Finance department representative
- Researcher
- Legal counsel
