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Ethikkommission Und Klinische Pr�fung: Vom Pr�fplan Zum Pr�fvertrag
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Ethikkommission Und Klinische Pr�fung: Vom Pr�fplan Zum Pr�fvertrag (Books & other media combined)

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Klinische Pr�fungen von Arzneimitteln (und Medizinprodukten) bilden den Gro�teil klinisch-medizinischer Forschung an Universit�ten. Mit derartigen Pr�fungen darf seit 1994 nach dem Arzneimittelgesetz erst begonnen werden, wenn eine zustimmende Bewertung einer Ethikkommission vorliegt. Schlie�lich wird der Sponsor mit dem Leiter der klinischen Pr�fung einen Pr�fvertrag abschlie�en. Nur die Grundz�ge des Verfahrens vor der Ethikkkommission sind durch die Verfahrensgrunds�tze des Arbeitskreises medizinischer Ethikkommissionen vorgegeben und werden von den Ethikkommissionen im Grundsatz auch angewandt. Da die Pr�fung vor Ort nicht einheitlich geregelt ist, bieten die Autoren anhand von Antragsformularen und Mustervertr�gen Anregungen und Hinweise f�r diejenigen, die sich dem Verfahren der Ethikkommissionen unterziehen.

Medical & VeterinaryBrances of medicinePharmacologyMedical & VeterinaryMedicine: general issuesHealth systems & servicesGeneral practice Publisher: Springer-Verlag Berlin and Heidelberg GmbH & Co. KG Publication Date: 02/07/1998 ISBN-13: 9783540642442  Details: Type: Books & other media combined Format: Books
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