Vol , Issue
Date of Publication: April 01, 2013
DOI: https://doi.org/10.20529/IJME.2013.032
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New EU regulation on clinical trials: the impact on ethics and safeguards for participants
Annelies Den Boer
Irene Schipper
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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©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0), which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.