For Sponsor/CRO

Cooperation, Contracting and Settlement

The contracting procedure is initiated by the Sponsor’s enquiry addressed to the selected Investigator regarding their interest in the study and the feasibility of its conduct at the Site. A further prerequisite for commencing the procedure is the completion and submission of the signed „Application for Preliminary Approval to Conduct a Clinical Trial / Research Experiment”. A clinical trial is conducted on the basis of a tripartite agreement concluded between the Sponsor/CRO, the Investigator and the Site.

The draft tripartite agreement shall include at least the following provisions:

• inclusion of fixed fees in the agreement in accordance with the price list;

• clause on the choice of Polish law (compliance with Polish and European law);

• jurisdiction clause – any disputes shall be submitted for resolution to the court having jurisdiction over the registered seat of the Hospital/Site;

• settlement periods of three months;

• inclusion of fixed fees in the agreement in accordance with the price list.

Required Documents

• protocol synopsis and flow chart in the Polish language;

• draft tripartite agreement (together with all annexes) in the PL/EN version (if applicable);

• proposed remuneration for the Site and the Investigator;

• copy of the Sponsor’s third-party liability insurance policy for the duration of the agreement;

• Sponsor’s/CRO’s registration documents and powers of attorney translated into Polish (if applicable);

• list of products/materials and equipment (medical and non-medical) to be supplied by the Sponsor (if applicable).