Fees
Payments are intended to cover costs associated with the activities of the Ethics Committee of UHKT (operation of the EC office, costs related to the assessment and review of the study and its administration). The founder of the Ethics Committee of UHKT requires from applicants requesting a favorable opinion on clinical drug evaluation to pay administrative and other costs for reviewing the request in the following amount:
Review of a new clinical trial:
A) Review of basic study documentation: 12,000 CZK excluding VAT
(study protocol, Investigator's Brochure, CRF, study insurance, curriculum vitae of the principal investigator, patient information, informed consent)
B) Review of supplements to the clinical study:
- Protocol amendment and related documentation: 3 - 5,000 CZK excluding VAT (depending on the complexity of changes in the documentation)
- New patient informed consent: 1,000 CZK excluding VAT
- New Investigator's Brochure: 3,000 CZK excluding VAT
C) Medical device test: 12,000 CZK excluding VAT
Exemption from payment
Grant studies within national and international scientific research programs are exempt from payment.
Please provide the following billing information with the submitted documents:
- company name and address
- Registration number, Tax ID
- address to which we will send the invoice
- other necessary billing information
VAT at the statutory rate will be added to the fee for reviewing the request.
Payments must be made only on the basis of an invoice by transfer to an account held at the Czech National Bank, code 0710.Account number 31438021/0100.