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Veränderung der Dokumentation in der klinischen Forschung durch XML, EDC und CDISC-Standards

Veränderung der Dokumentation in der klinischen Forschung durch XML, EDC und CDISC-Standards

          
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About the Book

Inhaltsangabe: Zusammenfassung: Die Diplomarbeit verfolgt zwei Zielstellungen: Erstes Teilziel ist, die Veränderung der Dokumentationsprozesse und des Datenmanagements in der klinischen Forschung durch die verstärkte Integration von Electronic Data Capture (EDC) - Technologien darzustellen. Hierbei wird verstärkt auf die Bedeutung eines einheitlichen, Datenstandards für die Branche sowie die diesbezüglichen Entwicklungsarbeiten des Clinical Data Interchange Standards Consortium (CDISC) eingegangen. Zweites Teilziel ist, den speziellen, veränderten Bildungsbedarf in der klinischen Forschung sowie das diesbezügliche Ausbildungsangebot in Deutschland darzustellen und dementsprechend Ansatzpunkte zur Planung einer E-Learning gestützten Schulung zu geben. Die Diplomarbeit ist aufbereitet sowohl für branchenfremde Betriebswirtschaftler, als auch für nicht auf die klinische Forschung spezialisierte Mediziner und Pharmazeuten ohne Programmiervorkenntnisse. Im ersten Abschnitt werden zunächst der Bedarf, die Nutzenpotentiale und die Perspektiven der Extensible Markup Language (XML) zur technischen Realisierung von Datenstandards im allgemeinen erläutert sowie eine kurze Einführung in die Codierung von XML-Dokumenten und Dokumenttypbeschreibungen gegeben. Im zweiten Abschnitt werden der Arzneimittelforschungsprozess in seinen verschiedenen Phasen sowie grundlegende ethische und rechtliche Rahmenbedingungen beschrieben. Hierauf aufbauend werden die Kosten von klinischen Studien sowie ebenfalls die Entwicklung des deutschen im Vergleich zum internationalen Pharmamarkt behandelt. Als eine mögliche Rationalisierungsmaßnahme im kostenintensiven Forschungsprozess wird am Ende dieses Abschnitts die Integration von EDC herausgestellt, welche wiederum die Grundlage für den Bedarf nach einem brancheninternen Datenstandard für die klinische Forschung bildet. Der dritte Abschnitt beschäftigt sich mit den Arbeiten, den XML-basierten Standards sowie dem aktuellen Entwicklungsstand von C


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Product Details
  • ISBN-13: 9783838682259
  • Publisher: Diplom.de
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Spine Width: 9 mm
  • Width: 148 mm
  • ISBN-10: 3838682254
  • Publisher Date: 25 Aug 2004
  • Height: 210 mm
  • No of Pages: 156
  • Series Title: German
  • Weight: 213 gr


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Veränderung der Dokumentation in der klinischen Forschung durch XML, EDC und CDISC-Standards
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