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Ethikkommission und klinische Prüfung: Vom Prüfplan zum Prüfvertrag(German)

Ethikkommission und klinische Prüfung: Vom Prüfplan zum Prüfvertrag(German)

          
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About the Book

Klinische Prüfungen von Arzneimitteln (und Medizinprodukten) bilden den Großteil klinisch-medizinischer Forschung an Universitäten. Mit derartigen Prüfungen 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 Prüfung einen Prüfvertrag abschließen. Nur die Grundzüge des Verfahrens vor der Ethikkkommission sind durch die Verfahrensgrundsätze des Arbeitskreises medizinischer Ethikkommissionen vorgegeben und werden von den Ethikkommissionen im Grundsatz auch angewandt. Da die Prüfung vor Ort nicht einheitlich geregelt ist, bieten die Autoren anhand von Antragsformularen und Musterverträgen Anregungen und Hinweise für diejenigen, die sich dem Verfahren der Ethikkommissionen unterziehen.

Table of Contents:
I. Einführung und Formulare.- 1. Einführung.- 2. Antragsformular.- 3. Schlußbericht über die Untersuchung.- 4. Statut einer Ethikkommission.- 5. Prüfvertrag (Muster).- II. Vorbemerkungen: Rechtliche Struktur der Ethikkommission.- 1. Rechtsgrundlagen.- 2. System: Verhältnis der Normen zueinander.- 3. Aufgaben und Funktionen.- 4. Bildung, Besetzung und Zuständigkeit von Ethikkommissionen.- 5. Gegenstand, Art und Ergebnis der Prüfung.- 6. Verfahren vor der Ethikkommission.- 7. Multizentrische Studien.- 8. Multinationale Studien.- 9. Haftung und Versicherung.- 10. Gebühren und Auslagen.- III. Erläuterungen zum Antragsformular, zum Statut und zum Prüfvertrag.- 1. Antragsformular mit Erläuterungen.- 2. Schlußbericht über die Untersuchung.- 2. Statut mit Erläuterungen.- 3. PrüfVertrag mit Erläuterungen.- IV. Anmerkungen, Rechtsprechung und Literatur.- 1. Anmerkungen und Rechtsprechung.- 2. Literatur.- V. Anhang.- 1. Deklaration von Helsinki.- 2. Auszüge aus Gesetzen und Rechtsvorschriften.- 3. Richtlinie des Europäischen Parlaments und des Rates zur Angleichung der Rechts- und Verwaltungsvorschriften über die Anwendung der „Guten Klinischen Praxis“ bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln (Entwurf, Stand: 1997).- 4. Directive of the European Parliament and of the Council on the approximation of provisions laid down by law, regulation or administrative Action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medical products for human use (Entwurf, Stand: 1997).


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Product Details
  • ISBN-13: 9783540642442
  • Publisher: Springer-Verlag Berlin and Heidelberg GmbH & Co. KG
  • Publisher Imprint: Springer-Verlag Berlin and Heidelberg GmbH & Co. K
  • Edition: 1998 ed.
  • Language: German
  • Returnable: Y
  • Spine Width: 9 mm
  • Weight: 240 gr
  • ISBN-10: 3540642447
  • Publisher Date: 02 Jul 1998
  • Binding: SA
  • Height: 235 mm
  • No of Pages: 154
  • Series Title: German
  • Sub Title: Vom Prüfplan zum Prüfvertrag
  • Width: 155 mm


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