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Klinische Forschung
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Klinische Forschung hat als Forschung am kranken Menschen besonders hohen ethischen Anforderungen zu gengen. Neue Therapieformen drfen niemals ohne sorgfltige Erfolgskontrolle eingesetzt werden. Ethische Normen, wie die "Deklaration von Helsinki" und die Arzneimittelgesetze der einzelnen Lnder, legen unter anderem fest, da ein Prfplan ausgearbeitet werden mu. Dieses Buch hilft bei der Erstellung eines solchen Prfplans. Es beschreibt nicht nur, welche Punkte in einem Prfplan enthalten sein mssen, sondern gibt zahlreiche Hinweise, wie ein solches Forschungsprogramm zur Sicherheit der Patienten produktiv der Fragestellung angepat werden kann.
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