Fees

The payments are intended to cover the costs associated with the activities of the Ethics Committee of the IHBT (operation of the EC office, costs related to the review and discussion of the study and its administration). The founder of the Ethics Committee of the IHBT requires the sponsors of applications for a consent opinion on a clinical trial to pay administrative and other costs for the processing of the application in this amount:

Review of a new clinical trial:

A) Review of the basic study documentation: 12 000 CZK excluding VAT

(study design, Investigator's Brochure, CRF, study insurance, principal investigator's CV, patient information, informed consent)

B) Review of clinical study supplements:

• Amendments to the protocol and related documentation: 3 - 5,000 CZK excluding VAT (depending on the complexity of the changes in the documentation)
• New informed consent of the patient: 1 000 CZK without 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 programmes are exempt from reimbursement.

Please include billing information with your submission:

• company name and address
• ID NUMBER, VAT NUMBER
• the address to which the invoice will be sent
• other necessary billing information

VAT at the legal rate will be added to the application fee.

Payments must be made only on the basis of an invoice, by transfer to an account held with the Czech National Bank, code 0710, account no. 31438021/0100.