Support mechanisms for non-commercial clinical trials | Level | |||||||
National | EU Level (Multinational) | Global | ||||||
Dedicated webpage | Dedicated webpage in Estonian and English. | X | ||||||
Training courses | Webinars for both commercial and non-commercial sponsors. Materials are available on the Agency’s web page and upon request (recordings of the webinars). | X | ||||||
Scientific advice | Scientific and pre-submission advice is available for both commercial and non-commercial sponsors. Advice for non-commercial sponsors is free of charge. | X | ||||||
Helpdesk, regulatory, CTIS and ethics support | Regulatory, ethics requirements and CTIS support via the CT mailbox (trialsravimiamet [dot] ee (trials[at]ravimiamet[dot]ee)); phone +372 737 4140. In addition, there are regular meetings with the ethics committee to discuss best practices and harmonise procedures. | X | ||||||
Other services by National Competent Authority | Fee for specialised assessment of a clinical trial of a medicinal product Non-commercial sponsors are exempt from the specialised assessment fee. | X | ||||||
Services by ethics committee | As per the Clinical Trials Regulation, sponsors need only pay one fee per clinical trial (redistribution done by the national competent authority). | X | ||||||
Public GCP support | ||||||||
Public research office | X | |||||||
National funding and other financial support | Ministry of Education and Research | X | ||||||
Funding coordination and navigation of research infrastructure | Estonian Research Council | X | ||||||
Support identifying research networks | ||||||||
Other support mechanisms |