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Clinical Research and Regulatory Affairs Volume 27, 2010 - Issue 4
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Research Articles

Notification of suspected and unexpected serious adverse reactions according to the Clinical Trials Directive—A descriptive analysis of the legislation and the requirements in a European context

Ellen Moseholm LarsenCopenhagen HIV Programme, University of Copenhagen, Faculty of Health Sciences, The Panum Institute/Building 21.1, Blegdamsvej 3B, 2200 Copenhagen N, DenmarkCorrespondence[email protected]
,
Jesper GrarupCopenhagen HIV Programme, University of Copenhagen, Faculty of Health Sciences, The Panum Institute/Building 21.1, Blegdamsvej 3B, 2200 Copenhagen N, Denmark
,
Daniela Christine GeyCopenhagen HIV Programme, University of Copenhagen, Faculty of Health Sciences, The Panum Institute/Building 21.1, Blegdamsvej 3B, 2200 Copenhagen N, Denmark
,
Karoline B. JensenCopenhagen HIV Programme, University of Copenhagen, Faculty of Health Sciences, The Panum Institute/Building 21.1, Blegdamsvej 3B, 2200 Copenhagen N, Denmark
&
Ole KirkCopenhagen HIV Programme, University of Copenhagen, Faculty of Health Sciences, The Panum Institute/Building 21.1, Blegdamsvej 3B, 2200 Copenhagen N, Denmark
Pages 108-120 | Received 26 May 2010, Accepted 08 Jul 2010, Published online: 30 Aug 2010

References

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