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Zusatztext "...a well-written book and is likely to be of great value to practitioners in the clinical trial arena. I recommend it for the library of such individuals."--Biometrics! September 2000 Informationen zum Autor Richard K. Rondel is the editor of Clinical Data Management , 2nd Edition, published by Wiley. Sheila A. Varley is the editor of Clinical Data Management , 2nd Edition, published by Wiley. Colin F. Webb is the editor of Clinical Data Management , 2nd Edition, published by Wiley. Klappentext The authoritative source on clinical data management Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text will be a timely publication in an ever-changing field. The volume: * Is written by well-known and experienced authors in this area * Provides new approaches to major topics in clinical data management * Contains new chapters on systems software validation, database design and performance measures Clinical Data Management will be invaluable to anyone in the field of clinical data management within the pharmaceutical industry, or associated industries, and to all biomedical professionals working in clinical research. Zusammenfassung Der Begriff "Management von klinischen Daten" beschreibt die Aufgabe innerhalb eines pharmazeutischen Unternehmens, vollständige Protokollformulare klinischer Versuchsreihen für statistische Analysen und formelle Berichterstattung aufzubereiten. Geeignete, effiziente Verfahren sind erforderlich, um sowohl die Unternehmensziele zu erreichen als auch die Qualitätsprüfungen durch Kontrollinstanzen zu bestehen. "Clinical Data Management" ist ein wichtiger Leitfaden für alle Biomediziner im Bereich der klinischen Forschung. Diese 2. Auflage wurde umfassend aktualisiert und enthält darüber hinaus Beiträge neuer Autoren zu aktuellsten Entwicklungen und Forschungsansätzen. (10/99) Inhaltsverzeichnis Chapter Review (S. Cummings). The International Conference on Harmonisation and its Impact (B. Smith & L. Heywood). Case Report Form Design (M. Avey). Data Capture (E. Waterfield). Planning and Implementation (C. Thomas). Data Validation (P. Patel). Quality Assurance and Clinical Data Management (H. Campbell & J. Sweatman). Performance Measures (J. Wood). Data Presentation (M. Mehra). Coding of Data-MedDRA and other Medical Terminologies (E. Brown & L. Wood). Database Design Issues for Central Laboratories (T. Tollenaere). Computer Systems (L. Palma). Systems Software Validation Issues-Clinical Trials Database Environment (S. Hutson). Re-engineerng the Clinical Data Management Process (S. Arlington, et al.). Working with Contract Research Organizations (K. Buchholz). Data Management in Epidemiology and Pharmacoeconomics (M. Ryan & A. Pleil). Future Revisited (R. Lane). Index....
