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Additional Information
NB! The EC’s positive opinion must be issued before CA’s approval can be requested.
An ethics committee is defined as 'a body established with the approval of the Agency to protect the rights, safety and wellbeing of human subjects by, among other things, expressing their scientific and ethical opinion on the methods and documents to be used to inform trial subjects and obtain their informed consent' (Regulation on Clinical Trials of Medicinal and Biological Products 2015).
A standard operating procedure for ECs is available (Standard Operating Procedure for Clinical Trials and Bioavailability-Bioequivalence Studies 2015).
