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DOCUMENTUM LIBRARY

Code for Transparency

The Code for Transparency in Clinical Research (herinafter the Code) is the firm commitment of the clinical trial centres (trial organisers, helath professionals and patients), which participate in the "Development and Internationalisation of the Thematic Network for Clinical Research" (EFOP-3.6.2-16-2017-00009), to employ common principles for the transparency of clinical trials.

There is a strong demand from patients, sponsors and professional stakeholders for clinical trial centres to be fully accountable and transparent. For these reasons, the clinical trial centres are committed to appropriate transparency and, as far as possible, uniformity. By standardising the principles of transparency of the clinical trial centres, the activities of each centre can be assessed clearly. This is making it easier to establish a common ground for action with professional partners. At the same time, there is an increased demand from patients to obtain more information on clinical trials, including the process and the background of the trials. The information available to professional partners facilitates contact, contracting ad administrative processes.

This Transparency Code was adopted by the clinical trial centres and entered into force on 05 May 2019.

The aim of the clinical trial centres is to increase trust on behalf of the clients, professional participants, patients and their relatives. The Code also aims to ensure that each clinical trial centres presents professional information on clinical research in a uniform way, and that the operation, benefits and professional background of each clinical trial centres are easily undesatndable. This information is professionally relevant for investigators and sponsors and informative for the ly public.


The current price lists for additional diagnostic tests may be downloaded below.


Institute of Laboratory Medicine

Contact:
Anna Jauk, quality assurance manager - jauk.anna@pte.hu

Price List - Clinical Centre, Institute of Laboratory Medicine (Valid from 12 March 2024 to 31 December 2024)



Medical Imaging Clinic

Contact:
Annamára Csiki Kovácsné - csiki.annamaria@pte.hu

Price List - Clinical Center, Medical Imaging Clinic - Radiology (Valid from 1 May 2024 to 30 April 2025)



Institute of Medical Microbiology and Immunology

Price List - Clinical Centre, Institute of Medical Microbiology and Immunology (Valid from 1 February 2024 - 31 January 2025)



Institute of Pathology

Contact:  
Prof Tamás Tornóczki (Institute Director) - titkar.pathology.kk@pte.hu, tornoczki.tamas@pte.hu

Price List - Clinical Centre, Institute of Pathology



Institute of Clinical Pharmacy

Contact:  
Dr Béla Molnár, (Specialist Pharmacist) - molnar.bela@pte.hu 
Dr Valéria Czinner, (Specialist Pharmacist) - czinner.valeria@pte.hu 
Dr Zsolt Bodrogi - bodrogi.zsolt@pte.hu
Dr Dorottya Mayer, specialist pharmacist, (cytostatic infusion mixture) - mayer.dorottya@pte.hu

Price List - Institute of Clinical Pharmacy, Handling of investigational products for clinical trials (Valid from 28 February 2024)


Organisational and Operating Regulations for the University of Pécs (valid from 1 June 2022)

Organisational and Operating Rules for the Clinical Centre of the University of Pécs (valid from 1 June 2022)

Joint instructions of the Rector - Chancellor - Clinical Centre President on the regulations of commercial clinical research at the University of Pécs (No 1/2023, valid from 16 January 2023)

Appendices to the order of business are available from here

Joint instructions of the Rector - Chancellor - Clinical Centre President on the regulations of non-commercial clinical research at the University of Pécs (No 2/2023)

Procedures for commercial clinical trials at the University of Pécs (Expired on 16 January 2023 and repealed by the joint instructions of the Rector - Chancellor - Clinical Centre President (No 1/2023)

 

Appendices to the procedures are available from here (expired on January 16, 2023)

Procedures for the Registration Center for Human Clinical Trials at the University of Pécs Clinical Centre (Expired on 20 June 2020 and repealed by Rector - Chancellor - Clinical Centre President joint order No 8/2020.


The documents on the accreditation of the Institute of Laboratory Medicine, Clinical Centre, University of Pécs may be downloaded by clicking on the links below:

 


 

AUTHORITIES

Health Sciece Council 

National Pharmaceutical and Food Health Institue

National Health Serviced Provider Centre (ÁEEK)

Centre for Health Records and Training

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

 

LAWS

1997. CLIV. törvény az egészségügyről 

2006. évi XCVIII. törvény A biztonságos és gazdaságos gyógyszer- és gyógyászatisegédeszköz-ellátás, valamint a gyógyszerforgalmazás általános szabályairól

2005. évi XCV. törvény Az emberi alkalmazásra kerülő gyógyszerekről és egyéb, a gyógyszerpiacot szabályozó törvények módosításáról

 

REGULATIONS

235/2009. (X. 20.) - Government Decree on the rules of medical research conducted on humans, human
clinical trials of investigational products, and human clinical trials of medical devices

23/2002. (V. 9.) - Government Decree on medical research conducted on humans3/2002

35/2005. (VIII. 26.) - Government Decree on the clinical trials of investigational products for human use, and
the application of good clinical practice

33/2009. (X. 20.) - Government Decree on the clinical trials of medical devices

 

RECOMMENDATIONS

235/2009. (X. 20.) - Government Decree on the rules of medical research conducted on humans, human
clinical trials of investigational products, and human clinical trials of medical devices

23/2002. (V. 9.) - Government Decree on medical research conducted on humans

35/2005. (VIII. 26.) - Government Decree on the clinical trials of investigational products for human use, and
the application of good clinical practice

33/2009. (X. 20.) - Government Decree on the clinical trials of medical devices

 

 

REGIONAL RESEARCH ETHICS COMMITTEE

Regional Research Ethitcs Committee

 

PROFESSIONAL BODIES

Hungarian Association of Clinical Trial Organizers (MKVT)

 

REPRESENTATIVE FOR PATIENT RIGHTS

Representative for patient rights

 

RESEARCH PROPOSAL

HECRIN consortium (EFOP-3-6-2-16-2017-00009)
 

 

PRESENCE IN THE PRESS

PTE ORVOSKARI HÍRMONDÓ JANUARY 2018 - SPONSORS' OPINION ABOUT HUMAN CLINICAL TRIALS AT THE UNIVERSITY OF PÉCS (page 27).

 

 

 

 

 


Under development...


In this section you may find all the documents that are required for the clinical trials, their documentation and thir 
concluding contracts . The documents are available by clicking on the file name.

 

Information regarding the conclusion of contracts, in Hungarian and English from 2024-02-06 Preliminary acceptance statement
Statement on additional diagnostic tests, in Hungarian and English
Registration sheet of the investigated product, if it is delivered to the pharmacy of the Clinical Centre Registration sheet of the investigated 
product, if it is delivered to the test site
Statement of the Institute of Pharmacy
Statement of the Institute of Pharmacy on the delivery of the investigated product to the sit

 

 

 


Form for preliminary calculation

Form for final calculation

Form for requesting a proof of coverage

Form for requesting patient reimbursement

Form for opening financial centre

Commissioning Agreement for Participant_20240101 (Human Clinical Trial I, VV) 

Commissioning Agreement for Participant_20240101 (Human Clinical Trial II, MV) 

Commissioning Agreement for Participant_20240101 (Human Clinical Trial III, V-VSZ) 

Commissioning Agreement for Participant_20240101 (Human Clinical Trial IV, M-VSZ


The activities of the Coordination Centre for Clinical Trials (KVKK) wish to meet the high expectations of its partners 
and stakeholders who use its services.
The KVKK aims to achieve this via the introduction of MSZ EN ISO 9001:2015 Quality Management System.
After resolving the initial problems following the introduction of this standard, the KVKK wishes to obtain a certificate 
of compliance from an external body.

Quality policy statement

Certificate

Register of Documents
The documents included in the Register of Documents may be requested by sending an email to kvkk@pte.hu. 
The message should contain the name of the requester and the description of his relationship with the 
University of Pécs. 


The adresses of the University of Pécs which are included 
in the OMS database can be reached ON THIS LINK.