Information for Sponsors / Contract Research Organisations (CROs) of clinical trials
All aspects of negotiating and conducting clinical trials of medicinal products or medical devices are looked after by the Clinical Trials Section and the Research Clearing Unit.
Section of Clinical Trials and Research Clearing Unit
Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw
137 Wołoska Street
Coordinator: Mgr. Monika Wojciechowska
Clearing and Financial Negotiations: Barbara Olga Pankowska, Mgr. Magdalena Kubiś
Ph: +48 (22) 508 16 49; +48 (22) 508 16 47
Head of the Section of Clinical Trials and Research Clearing Unit
Dr med. Janina Małgorzata Michalak
Clinical trials at the Central Clinical Hospital of the Ministry of the Interior and Administration are subject to a trilateral agreement between the Sponsor, Principal Investigator and the Hospital.
I. The list of documents necessary for negotiating a trilateral agreement:
- A request form to the Director of the Hospital completed by the principal investigator - Attachment 1
- Electronic or paper version of the Study Protocol
- Summary of the Study Protocol in Polish
- Summary of the flow chart in Polish
- Detailed schedule of medical procedures to be performed, consistent with the study protocol, in Polish
- Current evidence of registration of the Sponsor /CRO in the National Court Register or certificate of business registration
- Research Insurance Policy
- The power of attorney to represent the Sponsor / CRO
- Proposal of fee structure for the hospital and the investigator
II. Conditions for concluding a trilateral agreement
The Section is responsible for effectively negotiating and signing agreements. This process can take between 6-8 weeks. The time it takes to complete the process can vary and relies upon the flow of information between the Sponsor / CRO, investigator and the Hospital.
The stages of negotiation and conclusion of the agreement:
- The Director of the Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw signs the Request Form (attachment 1)
- Registration of the Clinical Trial by the coordinator of the Section of Clinical Trials and Research Clearing Unit in the Register of Clinical Trials Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw, in order according to the number assigned to the trial / BK / year.
- Dispatch of the draft trilateral agreement by the Sponsor / CRO, together with the required documents for formal/legal, technical and financial/budgetary analysis (our agreement can be used as a template)
- The payment of the fee referred to in Part IV point 1
- Negotiation provisions of the agreement between the Sponsor / CRO, the Hospital and the Principal Investigator
- Formal/legal analysis
- Financial/budgetary analysis (budget breakdown between the Hospital and the Principal Investigator)
- Approval of the draft agreement by the Head of the Section of Clinical Trials and Research Clearing Unit
- Upon approval and acceptance of the final version of the trilateral agreement on paper, the agreement must be signed by the following and in this order: Sponsor or a person authorized by the Sponsor or CRO, Principal Investigator and the Director of the Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw.
III. Implementation of the Clinical Trials
Once all parties have signed the trilateral agreement, the process of obtaining the approval of the Bioethics Committee and a URPL number (CEBEK) can commence.
The Principal Investigator and the Sponsor are required to notify the Section of Clinical Trials and Research Clearing Unit of the date of commencement of the trail (inclusion of the first patient) and its conclusion (the last visit of the last patient).
- The sponsor / CRO is obliged to provide the Section of Clinical Trials and Research Clearing Unit with the URPL number (CEBEK) and send the consent of the Bioethics Committee.
- All medical equipment, information technology, and other materials (excluding medication) provided by the Sponsor / CRO to the Principal Investigator / Centre for the purposes of the clinical trial and mentioned in the agreement / annexes / attachments / acceptance protocols will be included in the off-balance sheet of the accounting records, in accordance with the procedures of the Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw.
- The Principal Investigator and Sponsor / CRO will send reports on the implementation of the clinical trial in accordance with the agreement to the Section of Clinical Trials and Research Clearing Unit
- The Sponsor / CRO will provide the Section of Clinical Trials and Research Clearing Unit with two weeks notice of planned or early conclusion of trials at the Hospital.
IV. Fixed fees associated with the conducting of a Clinical Trial required by Central Clinical Hospital of the Ministry of the Interior and Administration:
- Implementation fee for conducting a clinical trial involving administrative costs associated with the preparation and financial and formal/legal analysis of the documentation provided.
- Archival fee for archiving medical records per one patient for 15 years
- Pharmaceutical fee applies to records of drugs / medical devices tested
V. Financial and Budgetary Analysis
In the analysis of financial and budgetary studies, the following costs of procedures according to the commercial rates of hospital should be included:
- The costs of planned outpatient visits / days of hospitalization
- The costs of procedures / tests / benefits in accordance with the schedule contained in the Study Protocol
- Unplanned visits and procedures not resulting from the Study Protocol.
At the end of each billing period (quarterly) the Sponsor must provide the Coordinator of the Research Clearing Unit at the Central Clinical Hospital of the Ministry of the Interior and Administration with information including the number of visits, procedures performed, and research patients enrolled in the clinical trial.