Richard K. Rondel / Sheila A. Varley / Colin F. Webb (Hgg.)

Clinical Data Management

Ed. by Richard Rondel, Sheila Varley and Colin Webb

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Wiley & Sons
• 2. Aufl.
• Seitenzahl: 368
• Erscheinungstermin: 3. Februar 2000
• Englisch
• Abmessung: 235mm x 157mm x 26mm
• Gewicht: 730g
• ISBN-13: 9780471983293
• ISBN-10: 0471983292
• Artikelnr.: 08450936

Autorenporträt

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.

Inhaltsangabe

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.

Rezensionen

"The key to enduring research is data quality and data quality depends upon data management. How fortunate then that the start of the New Millennium sees the publication of the second edition of 'Clinical Data Management'. ... Admirably concise and authoritatively penned, it provides an excellent introduction to a subject at the heart of pharmaceutical R&D.", Dr Hugh Boardman, Partner in Boardman Clarke, Pharmaceutical Physician#

"...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