Clinical trials – information for the Sponsor
Rules of conduct when concluding contracts for the performance of sponsored clinical trials
- The basis for conducting clinical trials based in the Oncology Centre of prof. F. Łukaszczyk in Bydgoszcz is the conclusion of a tripartite agreement between the Sponsor/CRO applying for the study, the researcher and the Oncology Centre of prof. F. Łukaszczyk in Bydgoszcz.
- The procedure of concluding a contract for conducting a clinical trial begins with a submission of a query by a Sponsor to a selected researcher regarding an interest in a given topic and the possibility of conducting a trial.
- The Sponsor/CRO submits a request for preliminary consent to conduct a clinical trial by submitting to the Medical Director an Application for preliminary consent to conduct a clinical trial together with confirmation of payment of the “fee for initiating the procedure for concluding a clinical trial contract”. A scan of the filled and signed application together with a confirmation of payment should be sent by e-mail to the following address: email@example.com or to the address of the Centre. The Medical Director, on the basis of the Application for preliminary consent to conduct a clinical trial submitted by the Sponsor/CRO, tentatively agrees to start cooperation.
- After obtaining approval of the Medical Director, the procedure of contracting the trial begins. The Sponsor/CRO submits the following documents to the Senior Clerk for Internships, Trainings and Clinical Trials:
- clinical trial protocol;
- summary of the protocol and a list of procedures (flow chart) in Polish;
- draft of the tripartite agreement;
- a proposal for remuneration for the Research Centre and the Researcher with the division of remuneration for the procedures in the proportion – 40% the Centre / 60% the Researcher;
- a copy of the Sponsor’s insurance policy confirming the conclusion of a civil liability insurance contract for damages caused in connection with the provision of services in the scope of the subject of the trial, for the duration of the contract;
- registration documents of the Sponsor/CRO;
- a letter of attorney for the person who will represent the Sponsor/CRO, unless it is indicated as the body authorized for representation;
- a complete template of the CRF form (scope of personal data provided);
- a list of medical products and materials necessary for the conduct of the clinical trial, which will be provided by the Sponsor;
- a list of medical and non-medical equipment necessary to conduct the clinical trial, which will be provided by the Sponsor;
- The terms of the clinical trial agreement are negotiated between the Sponsor/CRO, the Researcher and the Centre. On the part of the Oncology Centre, the negotiations are conducted by senior clerk for internships, trainings and clinical trials in consultation with the Medical Director and the Economic Director – Chief Accountant. The negotiated arrangements are approved by the Director of the Centre.
- Each contract is reviewed by an attorney-at-law.
- All copies of source documents must be certified as true copies of the original by persons authorized to represent the Sponsor. The Centre has the right to demand that the original document be presented if its copy is illegible or raises doubts as to its compliance with the original.
- In the internal circulation of documentation in the Research Centre, the process of negotiating, signing and implementing of contracts is supervised by the Senior Clerk for Internships, Trainings and Clinical Trials.
- The contract shall enter into force on the date of its signing by the parties thereof, however the mutual rights and obligations of the parties resulting from the contract shall be suspended until the date on which the following conditions are jointly met:
- the Sponsor provides a certificate from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products on the registration of the study in the Central Register of Clinical Trials;
- the Sponsor provides a legally valid resolution of the Bioethics Committee expressing a positive opinion on the Research project.
- A copy of the contract shall each be provided to: the Researcher and the Senior Clerk for Internships, Trainings and Clinical Trials.
Fixed costs related to signing the contract:
|Fees for initiating a procedure for concluding a contract to conduct a clinical trial/study||PLN 3,000.00|
|Administrative and legal fees||PLN 8,000.00|
|Fee for archiving documentation for each year of the trial/study||PLN 2,000.00|
|Fee for storing the product in the Hospital Pharmacy of the Centre for each year of the trial/study||PLN 2,000.00|
|Fee for archiving documentation after completion of the trial/study||PLN 3,500.00|
The amounts given are net amounts and due VAT must be added.