New EU regulation on clinical trials: the impact on ethics and safeguards for participants

Annelies Den Boer, Irene Schipper

DOI: 10.20529/IJME.2013.032


Abstract

The European Commission has proposed a new regulation to replace the current clinical trials directive. The proposed regulation aims at accelerating the application procedure and simplifying and harmonising the administrative requirements for multi-centre trials across the European Union.

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