Clinical Trials

Agar plates used for growing bacteria.Polish Mother’s Memorial Hospital Research Institute has been involving in the implementation of multi- center and international clinical trials for many years. Highly qualified personnel stay current with adequate specializations and realization of research work, including clinical research. It guarantees successful cooperation and accomplishment of works.

The Institute has full medical and diagnostic base. There is also independent Commission for Bioethics in the Institute, which expresses an opinion about projects of planned research. Our researchers and medical personnel, who care of patients, follow the rules of Good Clinical Practice. Currently, sixteen clinical trails are carried out at the Institute.

Areas of clinical research realized in our Institute:

  • Allergology
  • Anesthesiology
  • Metabolic Diseases
  • Dermatology
  • Diabetology
  • Endocrinology
  • Gastroenterology
  • Immunology
  • Cardiology
  • Nephrology
  • Neurology and Neurosurgery
  • Oncology,
  • Urology

The process of signing agreements about cooperation and implementation of clinical and observational studies, but also supervising the proper execution of contracts is coordinated by Department of Science and Research Collaboration in Polish Mother’s Memorial Hospital Research Institute.

Contact:
E- mail: badania.kliniczne@iczmp.edu.pl
phone: +48 42 271 16 05

There is a procedure of clinical trials that has to be fulfilled. The clinical trials have to include a trilateral cooperation agreement between the entity requesting the study (sponsor/ legal representative of the sponsor or CRO organization, having a residence in the territory of one of the member state of the European Union or the member states of the European Free Trade Association (EFTA)) and researcher of Polish Mother’s Memorial Hospital Research Institute.

A clinical trial may begin after the signing the cooperation agreement, favorable opinion of the Committee for Bioethics and the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocides for conducting the test.

In order to make trilateral arrangement on clinical trials, the following scheme has to be fulfilled:

  1. Sponsor reports that he/she is willing to carry out a clinical trial in Polish Mother’s Memorial Hospital Research Institute, directly to the Chief Researcher.
  2. According to the procedure of the Institute, Chief Researcher chosen by the requesting entity should submit completed application for registration of a clinical trial with attachments to the Department of Scientific and Research Cooperation in Polish Mother’s Memorial Hospital Research Institute.

This application will provide a basis to begin discussions with the sponsor or representative of sponsor in case of possible cooperation (application form for registration a clinical trial).

Attachments to application:

  • summary of the clinical trial in Polish and English version,
  • test protocol in Polish version containing data about the number of patients, accurately described procedures (additional researches needed, medical services),
  • financial conditions- proposed “ start up fee”, the fee for archiving documents, preliminary estimate predicts 30% of indirect costs for the Institute.
  1. The completed application with attachments has to be submitted to Department of Scientific and Research Cooperation in Polish Mother’s Memorial Hospital Research Institute
  2. After the consent of President of Polish Mother’s Memorial Hospital Research Institute, the sponsor is obliged to submit to the Department the following documents:
    • project of trilateral agreement with the proposal of the budget,
    • the investigator’s brochure,
    • copy of an estreat form the National Court Register of sponsor and/or requesting entity on its behalf or certification of business activity register or another copy that confirms the status of the sponsor (certified to be a true copy),
    • VAT declaration of sponsor,
    • a copy of a liability insurance of researcher and sponsor for the damage caused in connection with the conduction of clinical trials,
    • protocol of research,
    • sponsor registration documents,
    • authorizations, certifications etc.
  1. Accepted from the formal –legal and financial side, the project of trilateral agreement, signed by President of Polish Mother’s Memorial Hospital Research Institute and by both sides is the basis to start the clinical trial in the Institute.