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Registration Centre of Human Clinical Trials

FAQ - FOR HEALTH PROFEESIONALS

Whom can I turn to for help if I want to start a clinical trial at one of the departments of the Univertsity of Pécs?
Contact our coordinators
Phone: +36 72 536001 (Ext 35003)
Email: see TEAM MEMBERS and CONTACT

 

From where can I download the documents wich are required for a contract?

The necessary documents for our partners can be found and downloaded from the DOCUMENT LIBRARY. Some of our 
documents are available in Hungarian and English.

 

How do know whether the given examination fits the profile of a department of the University of Pécs?

In the DEPARTMENTS menu item you can find the references for the specific department. This also shows the the clinical trial areas on which the department acquired lot of experience.

 

Who are the principal investigatiors, and what experience do they have?

References and areas of scientific interest of our principal investigators can be found in the DEPARTMENTS menu item. 
What documents must be submitted to Regional Research Ethics Committee (RKEB)?
The following documents must be submitted before starting the clinical trial:

  • protocol synopsis in Hungarian

  • patient information leaflet 

  • declaration of consent

  • liability insurance

  • OGYÉI (National Institute of Pharmacy and Nutrition) license

  • ETT KFEB (Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága) professional statement

  • statement on the payment of fee to RKEB

 

May the opening inspection visit of the clinical trial be held without the consent of the Regional Research Ethitcs Committee (RKEB)?

The opening inspection visit of the clinical trial may only be held if the contract was signed by the parties, and the OGYÉI 
licence is obtained.

 

Wh At whar intervals does the Regional Research Ethics Committee (RKEB) meet?

The legal advisor and secretary for RKEB Dr Erzsébet Románcz may provide more information on the operation and the regular 
meetings of the RKEB.
Phone: +36 72 535001 (Extension 33018)

 

Is it required to enter into separate contracts with the organisational units which perform additional diagnostics tests?

Pursuant to the current protocols of the university a contract must be concluded with the University of Pécs for all clinical trials which 
commence at the departments of the university. Separate contract should not be concluded with the organisational units which perform 
additional diagnostic tests.