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null Am I required to notify Fimea and the Ethics Committee of research where patients are randomised into two groups and both are administered a medicinal product with marketing authorisation in accordance with the Summary of Product Characteristics?

Am I required to notify Fimea and the Ethics Committee of research where patients are randomised into two groups and both are administered a medicinal product with marketing authorisation in accordance with the Summary of Product Characteristics?

Yes. Randomisation in an intervention that is not considered to constitute normal clinical practice.

 

10 Nov 2015