Clinical Trials

Agar plates used for growing bacteria.

Polish Mother’s Memorial Hospital – Research Institute has been involved in the implementation of multi- centre and international clinical trials for many years.

Highly qualified personnel, constantly trained in the areas of their specialties and carrying out scientific and research projects, including clinical trials, guarantees successful cooperation and implementation of works.

Our Institute administers medical and diagnostic facilities. The Institute has an independent Research Ethical Committee reviewing planned research projects. Our researchers and medical staff, in the interest of the patient’s good, always follow the principles of Good Clinical Practice.

Currently, 47 clinical trials are being carried out at the Institute.

 

Fields of clinical trials carried out in our center:

  • Allergology
  • Anaesthesiology
  • 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 at Polish Mother’s Memorial Hospital – Research Institute.

Responsible persons:

  • Agata Bielecka – Dąbrowa, PhD
  • Karolina Guligowska, MA
  • Agnieszka Krzyżańska, MA (invoices )

 

Contact:
badania.kliniczne@iczmp.edu.pl
phone: +48 42 271 16 11

 

The condition for conducting clinical trials at the Institute is the conclusion of a trilateral cooperation agreement between the entity applying for the study (sponsor / legal representative of a sponsor or CRO organization), having its registered office on the territory of one of the European Union Member States or member countries of the European Free Trade Agreement (EFTA) ), researcher and PMMH-RI.

The clinical trial may begin after signing the cooperation agreement, favourable opinion of the Research Ethical Committee and the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for conducting the study.

In order to conclude a trilateral agreement for a clinical trial successfully, the following path should be followed:

  1. The sponsor declares the will to conduct a clinical trial at PMMH directly to the selected Principal Investigator.
  2. In accordance with the Institute’s procedure, the Principal Investigator, selected by the applicant, should submit a completed application for registration of the clinical trial with attachments to the Department of Science and Research Collaboration of PMMH-RI.

This application will be the basis for starting negotiations with the sponsor (sponsor’s representative) regarding possible cooperation.

Attachments to the application:

  • summary of the clinical trial in both Polish and English,
  • study protocol in Polish, containing data about the number of patients, thoroughlydescribed procedures (additional research needed, medical services),
  • Financial terms – the proposed “start-up fee”, documents archiving fee, initial cost estimate providing 30% of indirect costs for the Institute

 

  1. The completed application with attachments should be submitted to the PMMH-RI, Department of Scientific and Research Collaboration.
  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:
  • A draft of trilateral agreement with the proposal of the budget,
  • the investigator’s brochure,
  • a copy of an excerpt from the National Court Register of sponsor and/or entityacting on its behalf or certification of entry in the business register or other document confirming the status of the sponsor (certified to be a true copy),
  • Sponsor’s VAT declaration (in case the sponsor / recipient of an invoice will settle VAT in the country where the business activity is located, outside Poland),
  • a copy of Investigator’s and Sponsor’s liability insurance for the damage caused in connection with the conduct of the clinical trial,
  • research protocol,
  • sponsor’s/CRO’s registration documents,
  • authorizations, certificates.

 

  1. Accepted from the formal, legal and financial side, the trilateral agreement draft, signed by the President of Polish Mother’s Memorial Hospital – Research Institute and all Parties, is the basis to start the clinical trial at the Institute.