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Principles of cooperation

Principles of cooperation

Clinical trials performed in American Heart of Poland Inc. are conducted in accordance with all regulations applicable in Poland, particularly with the provisions of the Act of 6 September 2001 – Pharmaceutical Law (Dz. U. of 2008 Nr 45, poz. 271, with amendments), Minister of Health regulation of 2 May 2012 concerning Good Clinical Practise (Dz. U. of 2012, poz. 489) as well as international regulation

All clinical researches are conducted only after its approval by Bioethical Committee.

Before beginning the clinical trial a trilateral agreement has to be signed between Sponsor or his representative, AHP and Principal Investigator.

Before negotiations, research proposal (at least a summary of the protocol, study design, the proposed budget) must be submitted to the Clinical Research Director.

After submission of the research project, the Clinical Research Director and the Sponsor choose AHP centers where the study will be conducted. After that contract negotiation starts. For this purpose, you have to submit following documents:

  • Template of trilateral agreement together with the budget in Polish or Polish and English language
  • Investigator’s Brochure
  • The Study Protocol, Summary of the Protocol, Study Design
  • Third party liability insurance for Sponsor and Investigator
  • Information form for patient and informed consent to participate in the clinical trial

These documents are later verified by Legal Department and The Clinical Research and Trials Center of CCRD AHP.

After we receive these documents deputy of the chairman of AHP, Medical Director has to accede preliminary agreement for the trial.

The clinical trial can be started after all parties sign the agreement and after receiving Bioethical Committee and CEBK (Central Register of Clinical Trials) approval.

 

Before the Begin of the study, Sponsor or his representative is obliged to pay an administrative fee.

Contact information:

Assoc. Prof. Aleksander Żurakowski, MD, PhD – Clinical Research Director olek.zurakowski@ahop.pl

Anna Bryła-Wojciechowska, MPharm – Clinical Research Specialist anna.bryla@ahop.pl

Agata Krauze, MPharm – PhD, Clinical Research Specialist agata.krauze@ahop.pl

Stanisław Trznadel, MD – Clinical Research Coordinator stanislaw.trznadel@ahop.pl

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