| Legislation | Description of duty | §, para. | Form of fulfilment | Method of fulfilment | Frequency of performance (per year) | |
|---|---|---|---|---|---|---|
After the commencement of the clinical trial, the sponsor shall inform the State Institute for Drug Control and the Ethics Committee for Multicentre Trials, if such committee has expressed its opinion on the clinical trial, in writing within 60 days at the latest, of the date and place where the clinical trial was commenced in the Czech Republic. | Other | electronically: > data box in writing - postal service | 1 / year | |||
Submission of a report on the course of the clinical trial of the medicinal product to the State Institute for Drug Control. | form not prescribed | electronically: > data box in writing - postal service | cannot be determined | |||
Submission of an annual report on the safety of the medicinal product in the clinical trial to the State Institute for Drug Control. The sponsor shall submit the report annually within 60 days of the conclusion of data collection. | Other | electronically: > data box in writing - postal service | 1 / year | |||
Submission of information on the completion of the clinical trial of the medicinal product in the Czech Republic to the State Institute for Drug Control. The sponsor shall, without delay, draw up a summary report after the completion of the clinical trial in which the conclusions of the clinical trial and their interpretation are presented. | Other | electronically: > data box in writing - postal service | 1 / year | |||
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