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Ethikkommission Und Klinische Prufung: Vom Prufplan Zum Prufvertrag

Ethikkommission Und Klinische Prufung: Vom Prufplan Zum Prufvertrag (Books & other media combined)

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Klinische Prufungen von Arzneimitteln (und Medizinprodukten) bilden den Grossteil klinisch-medizinischer Forschung an Universitaten. Mit derartigen Prufungen darf seit 1994 nach dem Arzneimittelgesetz erst begonnen werden, wenn eine zustimmende Bewertung einer Ethikkommission vorliegt. Schliesslich wird der Sponsor mit dem Leiter der klinischen Prufung einen Prufvertrag abschliessen. Nur die Grundzuge des Verfahrens vor der Ethikkkommission sind durch die Verfahrensgrundsatze des Arbeitskreises medizinischer Ethikkommissionen vorgegeben und werden von den Ethikkommissionen im Grundsatz auch angewandt. Da die Prufung vor Ort nicht einheitlich geregelt ist, bieten die Autoren anhand von Antragsformularen und Mustervertragen Anregungen und Hinweise fur 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
Availability: To Order. Estimated despatch in 1-3 weeks.  

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