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Guide for Investigator Initiated Trials

G. Fortwengel (Herausgeber)

Buch | Spiralbindung

148 Seiten

2011
Karger, S (Verlag)
978-3-8055-9684-8 (ISBN)

Lese- und Medienproben

Inhaltsverzeichnis (PDF)

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For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the 'International Conference on Harmonization and Good Clinical Practice'. This makes the publication at hand an essential 'cookbook' for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.

Erscheint lt. Verlag	4.4.2011
Zusatzinfo	7 fig.
Verlagsort	Basel
Sprache	englisch
Maße	210 x 280 mm
Gewicht	485 g
Themenwelt	Informatik ► Weitere Themen ► Bioinformatik
	Medizin / Pharmazie ► Gesundheitswesen
	Medizin / Pharmazie ► Medizinische Fachgebiete
	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht
Schlagworte	Communication • Data processing • documentation • General Medicine • Klinische Studie • Klinische Studie / Klinikstudie • medical law
ISBN-10	3-8055-9684-7 / 3805596847
ISBN-13	978-3-8055-9684-8 / 9783805596848
Zustand	Neuware