null How should Fimea be informed of the clinical trial results?
How should Fimea be informed of the clinical trial results?
The sponsor or the person responsible for the trial must provide Fimea with a report on the results of the trial not later than one year after it ends. The report should be submitted in the form of a summary, a synopsis, published article or in some other similar way.
The report on the results must also be submitted to the EU Clinical Trials Register. The sponsor should register as a results user in the EudraCT. Results of prematurely ended trials, or if ended before 21.7.2013 and carried out with adult participants can be posted in EudraCT in the form of pdf document. More information about modalities can be found here.
Please see EudraCT´s homepage on posting and publication of results-related information on clinical trials.
9 Nov 2021