Clinical Trials (english version)

Information for sponsors

The University Hospital offers cooperation in the field of clinical trials of medicinal products and medical devices. We offer our partners a top health facility with modern technical equipment and experienced researchers.

The quality of services provided in clinical trials is evidenced by their increasing number. We cooperate mostly in oncology, haematology, and neurology. We are also experienced partners in internal medicine (cardiology, gastroenterology, diabetology, and metabolic diseases) and in surgery.

Clinical trials are performed in accordance with the valid Czech legal regulations, valid national and international clinical trial guidelines, and fully in line with ethical principles.

List of documents required for a clinical trial approval

•      Written application (letter) to consider a clinical trial, showing the full title of the clinical trial both in Czech and English language, protocol number (including the EudraCT number) and summarized aim of the clinical trial

•      Clinical trial protocol including all amendments

•      Summary of the clinical trial protocol in Czech language

•      Third party liability insurance

•      Approval by the State Institute for Drug Control (SÚKL)

•      Approval by EK (Ethics Committee)

•      Power of attorney

•      Copy of the sponsor’s entry in the Companies Register

•      Requirement for the provision of pharmacy services (see the form below to download)

•      Draft contract including economic calculation of expenses related to the clinical trial performance. The contract must specify expected duration of the clinical trial and expected number of included trial subjects.

•     Radiological examination manual

•     If the contract is not signed by the contracting authority, it is necessary to send a draft Indemnity Agreement (letter)

	Requirements for the Provision of Pharmacy Services for Clinical Trials DOCX (MS Word) file	72 kB
	Requirements for Providing Radiological Services for Clinical Trials of Drugs DOC (MS Word) file	83 kB
	Agreement to Borrow a Medical Device – TEMPLATE DOC (MS Word) file	89 kB

Contact person for the sponsor

Dáša Prokůpková

Legal Department

University Hospital Hradec Králové

Sokolská 581

500 05 Hradec Králové – Nový Hradec Králové

Tel. +420 495 832 881

dasa.prokupkova@fnhk.cz

Ethics Committee

https://www.fnhk.cz/etikom