By Toby Miller, Ted Striphas, Kembrew McLeod, Michael Griffin, Michael Z. Newman, Jonathan Sterne, Alexandra Juhasz, Thomas A. Discenna, Victor Pickard, Carol Stabile, Fernando P. Delgado, Amy M. Pason, Kathleen F. McConnell, Sarah Banet-Weiser, Ira Wagman,

21 authors who bring up tough questions about educational hard work within the box of verbal exchange reviews. From defunding of universities to the genuine dilemmas dealing with directors: from the altering politics of careers to the ways in which gender and sophistication play out for college and scholars; from the categories of labor that get released and promoted to the tyranny of PowerPoint; from the politics of fundraising, to the devolution of management, to the function of unions in universities. The authors supply lots of proposals and courses for swap, from small yet significant gestures to activist courses for pedagogy and examine, to large proposals for organizing ourselves and remodeling the methods our departments and fields do company. within the method, they bring up much more provocative questions. Authors examine a bunch of matters immense and small, from defunding of universities to the genuine dilemmas dealing with directors: from the altering politics of careers to the ways in which gender and sophistication play out for college and scholars; from the categories of labor that get released and promoted to the tyranny of PowerPoint; from the politics of fundraising, to the devolution of management, to the position of unions in universities.

The authors supply lots of proposals and courses for swap, from small yet significant gestures to activist courses for pedagogy and examine, to giant proposals for organizing ourselves and reworking the methods our departments and fields do enterprise. within the method, they increase much more questions.

Contributors include:
Sarah Banet-Weiser, Fernando Delgado, Thomas Discenna, Michael Griffin, Jayson Harsin, Mark Hayward, Alex Juhasz, Kembrew McLeod, Kathleen F. McConnell, Toby Miller, Michael Z. Newman, Amy Pason, Victor Pickard, Michelle Rodino-Colocino, Joel Saxe, Carol Stabile, Ted Striphas, Ira Wagman and chairs who elected to stay nameless in order that they may inform their tales candidly.

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2. ^'^ Am bedeutsamsten sind in diesem Zusammenhang die klinischen Priifungen von Arzneimitteln gem. §§ 40ff. AMG und die klinischen Prii- ^0 Taupitz, MedR 2001, 277; Deutsch, NJW 2001, 857, 859; Lippert, MedR 2003, 681. '71 Deutsche Nm 2001, ^51, S5SI 72 RiLi 2001/20/EG des Europaischen Parlaments und des Rates vom 4. April 2001 zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten tiber die Anwendung der guten klinischen Praxis bei der Durchfuhrung von klinischen Priifungen mit Humanarzneimitteln, Abl.

649. 18^ Das defmierte Ziel einer Arzneimittelstudie hangt insbesondere davon ab, in welcher Phase sich die Priifung befindet. Zu den verschiedenen Phasen einer klinischen Prufang siehe oben 1. Teil, § 2 III 3 b. § 3 Rechte an Daten, Rohmaterial und Ergebnissen 35 trachtungen die Frage, wem das Publikationsrecht hinsichtlich der gewonnen Forschungsdaten und der mit ihrer Hilfe erzielten Forschungsergebnisse nach den gesetzlichen Regelungen ohne Beriicksichtigung einer eventuellen vertraglichen Abrede zusteht.

12. 12"^ Deutsch/Spickhoff, Medizinrecht Rn. 916; Rehmann, AMG § 40 Rn. 3. Fiir Zulassungsrelevante Studien hat sich die Form der doppelblinden, kontrollierten, randomisierten Studie durchgesetzt, s. Meister, DMW 2003; 128: 859. Zur Planung und Durchfuhrung § 2 Klinische Studien 29 gestellt werden die Gruppen nach einem wissenschaftlichen Zufallsverfahren, der sog. ^^^ Die Randomisierung wird durchgefiihrt, damit die bekannten und unbekannten individuellen Merkmale der Probanden gleichmaBig auf die Gruppen verteilt werden.

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