ECSubmissionFee object

Fees for Ethical review mandatory

Yes

Waiver for academic (non-commercial) studies possible

Yes

Fees for Ethical review

Fees for evaluation (in CZK -VAT included)

EC in role of MEC:
Multicentric clinical trial (up to 10 centers): 48 000 CZK (approx 1600 EURO)
For every center : 6 000 CZK (approx 220 EURO)
For every additional center (from 11th site) : 4 800 CZK (approx 180 EURO)
Evaluation of amendments: 6 000 CZK (approx 220 EURO)

EC acting as LEC in a multicentric study:
Approval for a single local study site: 12 000 CZK (approx 440 EURO)

Monocentric study: 24 000 CZK (approx 880 EURO)
(if study is extended to other sites and EC takes over the function as MEC: + 24 000 CZK)
Evaluation of revised application: 6 000 CZ)

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