[The role of the Danish Medical Products Agency in clinical trials]

Abstract

The registration and legislation concerning clinical trials are described with specific focus on subjects of importance to Danish doctors. Especially the investigators' responsibility for the registration of the trial, reporting of serious adverse events and final report to the agency are mentioned. The fact that the evaluation of a protocol will focus on the risk, the contents of essential new knowledge and the design are emphasised. The process of approval and the fees are mentioned, and finally the changes caused by the new GCP-directive are discussed.