原创力文档sponsor-investigator-relationship challenges, recent regulatory developments and future legislative trendssponsor-investigator-relationship挑战,最近的监管的发展和未来的立法趋势.pdf
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sponsor-investigator-relationship challenges, recent regulatory developments and future legislative trendssponsor-investigator-relationship挑战,最近的监管的发展和未来的立法趋势
Vol.3, No.12, 772-781 (2011) Health
doi:10.4236/health.2011.312128
Sponsor-investigator-relationship: challenges, recent
regulatory developments and future legislative trends
Raphael Richard Ciuman
Department of Otorhinolaryngology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany; ciuman.raphael@cityweb.de
Received 22 September 2011; revised 10 November 2011; accepted 26 November 2011.
ABSTRACT investigator and their relationship is crucial. The intro-
duction of the European Clinical Trials Directive (CTD)
Correct definition and management of sponsor-
2001/20/EC [1] and its national implementations, lead-
investigator relationship is of central impor-
ing to the 12th amendment of the German Drug Law
tance for planing and executing clinical trials.
(AMG, Arzneimittelgesetz) in August 2004 [2], have
During the last decade, there have been nu-
brought along a new legislative terminology and the
merous modifications of guidelindes, interna-
necessitiy of a thorough distinction between the various
tional and national legislations and regulations.
kinds of sponsorship and investigatorship and associ-
This implicated various alterations and shifts of
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