Clinical Trials are a research area of the University Hospital involving experienced and well-prepared hospital research staff.
Ladies and Gentlemen,
This section includes information about the rules for performing clinical trials at the University Hospital in Krakow.
Entities in charge of clinical trials at the University Hospital include the Innovative Treatment Centre, Clinical Trial Coordination Centre, and Clinical Trials Team.
We stand out with: :
- know-how and experience of our investigators,
- professional staff,
- large and diversified group of patients,
- broad access to diagnostic and treatment procedures.
We look forward to working together with you!
ul. Macieja Jakubowskiego 2 (H; -1), 30-688 Krakow
contact: 12 400 33 27, 12 400 33 29
Innovative Treatment Centre
The Innovative Treatment Centre – Clinical Trial Coordination Centre (CIT) is a specialised unit at the University Hospital in Krakow dealing with organisation, coordination, and supervision over clinical trials, according to the Good Clinical Practice (GCP).
The Innovative Treatment Centre – Clinical Trial Coordination Centre (CIT) at the University Hospital in Krakow has been operating since June 2009. Its main task is to assure top quality clinical trials at the University Hospital in Krakow. This has been made possible owing to the establishment of Standard Operating Procedures (SOP) which refer to all planned and cyclical measures (they regulate the full range of activities from training of staff participating in a trial, through trial feasibility assessment and the process of obtaining informed consent forms, to procedures for emergency situations), thus guaranteeing that clinical trials are conducted in a professional manner, assuring legal compliance.
The responsibilities of CIT staff include: :
- negotiation of a trilateral agreement and trial budget
- substantive and financial supervision over trials carried out at the Hospital
- settlement control – verification of visits in clinical trials
- holding the register of commercial and non-commercial (research) clinical trials
- cooperation with trial monitors and auditors, as well as supervisory authorities
- organisation of GCP training for investigator teams
The Innovative Treatment Centre – Clinical Trial Coordination Centre (CIT) deals with logistic and administrative support to investigators. It has its own premises for patient examination, as well as for drawing biological samples and their preliminary processing.
- Macieja Jakubowskiego 2 (Building H Level 0), 30-688 Kraków, phone: 12 400 33 27, 12 400 33 29
- Botaniczna 3, 31-501 Kraków, phone: 12 424 86 03, 12 424 86 32
About clinical trials
Clinical trials are the research area of the University Hospital’s activities
As a Teaching Hospital, we focus on our research activities and developing innovations in medicine through assuring appropriate background facilities, as well as the best qualifications for our investigator team. Owing to this, we can assure the quality and reliability of clinical trials we perform. The University Hospital in Krakow provides highly specialist healthcare services. We feature 32 specialist hospital wards with the total of almost 1600 beds for patients. Our hospital units have been equipped with the latest generation medical equipment. We have eight certified diagnostical units.
What are clinical trials?
Clinical trials are research programmes with respect to drugs or medical devices and involving patients in order to determine whether a new form of treatment is safe and effective. A clinical trial shall mean each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy (Article 2(2) of the Pharmaceutical Law, Polish Journal of Laws 2008.45.271, as amended).
Clinical trials contribute to progress in medicine.
They allow determining new methods for prevention, diagnostics, or treatment of various diseases.
Clinical trials are conducted according to strictly defined rules that regulate, among others, preconditions for inclusion in a trial.
Inclusion criteria are the factors that allow a given person to participate in a trial.
Exclusion criteria are factors that disqualify patients from participation in a trial (as defined in a clinical trial protocol).
Why are clinical trials conducted?
- To verify whether a new drug or a new device is safe and effective when applied in humans.
- To compare existing treatment methods to determine which one is better.
- To analyse various methods of applying standard treatments so that they are more effective, easier to administer and/or feature fewer adverse effects.
- To obtain information about the best method of applying a given treatment in various patient populations.
Objectives of clinical trials:
- Clinical trials are NOT oriented at treating patients, but at an objective observation of the efficacy and safety of a given medicinal product in patients with a given disease.
- Successful treatment is an option; it is equally probable that the patient’s health might deteriorate, or there will be no change at all.
- Determination of therapeutic benefits.
- Proving safety and tolerance.
- Evidencing patients’ improved quality of life through lower costs of treatment.
List of clinical trials
Currently, there are over 100 clinical trials conducted in a permanent manner.
The Innovative Treatment Centre – Clinical Trial Coordination Centre (CIT) supports clinical trials applying new treatments in the following areas of medicine:
Below is the list of currently conducted clinical trials at particular units of the University Hospital in Krakow, as well as contact data to the units in charge of such trials.
The list is updated every three months.
For the Sponsor
The terms for conducting clinical trials at the University Hospital in Krakow have been defined in 32 Standard Operating Procedures (SOP) to assure top quality standards of research, patient safety, data reliability and data protection, as well as transparency of trilateral cooperation among the Sponsor, the Investigator, and the Centre.
Contact with the Hospital
The procedure aimed at entering into a clinical trial contract is initiated by the contact of the Sponsor/Contracting Authority with the selected Principal Investigator or the Innovative Treatment Centre – Clinical Trial Coordination Centre (CIT).
The Sponsor/Contracting Authority shall inform about the will to conduct a trial at the University Hospital in Krakow by sending a request at the e-mail address: email@example.com
The request should include: the name of the Sponsor/Contracting Authority, trial title, full name of the Principal Investigator, trial site, as well as contact data of the Sponsor/Contracting Authority.
CIT shall send the Hospital’s standing as to initiating negotiations regarding the contract, and shall provide the rules for negotiating contractual terms.
Documents required for the contract
The following documents shall be required in order to initiate the procedure and entering into a clinical trial contract, to be prepared by the Sponsor or the Principal Investigator in cooperation with CIT, respectively:
Negotiations and signing the contract
- The Clinical Trial Team shall conduct negotiations regarding a clinical trial contract after receiving the complete set of the documents mentioned above.
- The contract of a clinical trial includes administrative fees for the Hospital in the form of an initial fee (collected after the conclusion of the contract) and an annex fee (collected in the event of signing an annex covering a change in financial conditions), paid by the Sponsor / Principal in the amount not lower than respectively: 7000.00 PLN net and PLN 1500.00 net.Clinical trial contracts shall include the preliminary charge imposed by the Hospital (charged after contract conclusion) and an annex fee (charged in the event of concluding an annex amending the financial terms), to be paid by the Sponsor/Contracting Authority in the amount not lower than PLN 7000 and PLN 1500, respectively. Archiving fee PLN 5000.
- The archiving fee for the 25 year period of storing audit documentation is PLN 5,000.00 net. In the case of the Sponsor's decision to store the documentation for a longer period of time than 25 years, the cost of the archiving fee will be valued individually (not less than PLN 5,000.00 net.)
The pharmacy fee includes, but is not limited to, the costs of: storage space for the test product and storage conditions, in accordance with the Sponsor's recommendation regarding the required temperatures; storage time of the investigational product for the duration of the clinical trial (no longer than 36 months); the place and cost of utilities necessary for the preparation of the investigational product (drugs administered intravenously); space for the documentation and administration of the study in the hospital pharmacy. The Pharmacy fee amounts to:
1. PLN 5,000.00 net for clinical trials using drugs in a solid form, administered orally, drugs in the form of ready-to-use subcutaneous injections, which do not require preparation in a hospital pharmacy, and all other drugs not listed in point b) which are to be used as a test product.
2. PLN 7,000.00 net for clinical trials with the use of the test product in the form of parenteral, subcutaneous, intrathecal injection or infusion, the preparation of which is performed in a hospital pharmacy.
In clinical trials lasting longer than 36 months, the pharmacy fee will be priced individually (in the amount not lower than in point 4.)
The necessary number of printed copies of the final tripartite agreement is delivered by the Sponsor to the Hospital to be signed by the other parties.
For any additional information, please contact: firstname.lastname@example.org