Úsek pro vědu a výzkum

For commissioners of trials

Feasibility

Clinical study proposals (feasibility) should be sent to the Clinical Trials Department.

Contact for feasibility:

Mgr. Mgr. Iva Černeková

clinicaltrials@uhkt.cz, iva.cernekova@uhkt.cz

tel. 221 977 432

Name list of potential Principal Investigators at IHKT

Confidentiality Agreement (CDA)

We accept an individual CDA between the potential PI and the sponsor/CRO or even a Master CDA between the IHKT and the study sponsor/CRO. We also sign CDAs electronically in wet-ink. CDA proposals should be sent to the Clinical Trials Department.

Site Selection Visit

Contact the Clinical Trials Department to schedule a site selection visit (SSV). The selected Principal Investigator, Co-Investigator, and the Clinical Trials Department Head will attend the Site Selection Meeting. A personal visit is preferred.

Start-Up Phase

The start-up phase includes:

  • Assembling the study team
  • Preparation of documents for the study team (CV, GCP, IATA, etc.).
  • Financial Disclosure (FD)
  • Study Centre Suitability Document
  • Declaration of Compliance (IVDR)
  • Laboratory certificates (accreditation, ranges)

Contract and budget

There is only 1 three-party contract at the IHKT. Separate contracts are not allowed. The only recipient of payments (100%) is the IHKT, which distributes the funds (including remuneration for the study team) according to internal regulations (Director's Directive No.01/2020 on the implementation of the KH in the IHKT). The budget also includes the personal costs of the study team. ÚHKT has an approved internal price list for KH at ÚHKT, which is an annex to the Director's Directive No.01/2020.

Contracts for the provision of services of the Apheresis and Cell Therapy Departments

The IHKT collaborates with other centres in clinical trials and provides apheresis services and storage of the finished product prior to administration to the patient. Contract negotiations and budgeting for this type of contract are handled by the Clinical Trials Department, including administrative support during the start-up phase.

Patient Compensation

We prefer to pay in cash at the IHCT cashier's office. Payment to a card provided by the sponsor, through a payment vendor, is also acceptable. In case of cash payment, we require a lump sum payment in advance.

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