ÚHKT - Ústav hematologie a krevní transfuze
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For study organizers

Feasibility
Send clinical trial feasibility offers to the Clinical Trials Department.

Contact for feasibility:
Mgr. Iva Cerneková
clinicaltrials@uhkt.cz, iva.cernekova@uhkt.cz
tel. 221 977 432

List of potential principal investigators at UHKT

Confidentiality Agreement (CDA)
We accept individual CDAs between the potential PI and the study sponsor/CRO or Master CDA between UHKT and the study sponsor/CRO. We sign CDAs electronically and in wet-ink format. Please send CDA proposals to the Clinical Trials Department.

Site Selection Visit
To schedule a site selection visit (SSV), contact the Clinical Trials Department. The site selection visit is attended by the selected principal investigator, co-investigator, and head of the Clinical Trials Department. We prefer in-person visits.

Start-Up Phase
The start-up phase includes:

  • ​Assembly of the study team
  • Preparation of documents for the study team (CV, GCP, IATA, etc.)
  • Financial Disclosure (FD)
  • Document Suitability of the study center
  • Declaration of Conformity (IVDR)
  • Laboratory certificates (accreditation, range)

Contract and Budget 
At UHKT, only 1 tripartite contract is concluded. Separate contracts are not permitted. The sole recipient of payments (100%) is UHKT, which distributes the funds (including remuneration for the study team) according to internal regulations (Director's Directive No. 01/2020 on conducting clinical trials at UHKT). The budget also includes personnel costs for the study team. UHKT has an approved internal price list for clinical trials at UHKT, which is attached to Director's Directive No. 01/2020.

Service Provision Contracts for the Apheresis Department and Cell Therapy Department
UHKT collaborates with other centers within clinical trials and provides apheresis services and storage of finished product before administration to the patient. Negotiation of contracts and budgets for this type of contract is handled by the Clinical Trials Department, including administrative support in the start-up phase.

Patient Compensation
We prefer cash payment at the UHKT cashier. Payment to a card provided by the sponsor through a payment vendor is also acceptable. In case of cash payment, we require an advance lump-sum payment in advance.

Contact for feasibility, CDA, site selection visits, start-up, contract and budget proposals, invoicing: