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Thought you might be interested in seeing "New EU regulation on clinical trials: the impact on ethics and safeguards for participants" by Boer Annelies,Schipper Irene published in Vol 10, No 2 (2013) of Indian Journal of Medical Ethics at "https://ijme.in/articles/new-eu-regulation-on-clinical-trials-the-impact-on-ethics-and-safeguards-for-participants/".
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