Clinical Data Management / Edition 2 available in Hardcover
- Pub. Date:
Extensively revised and updated, with the addition of new chaptersand authors, this long-awaited second edition covers all aspects ofclinical data management. Giving details of the efficient clinicaldata management procedures required to satisfy both corporateobjectives and quality audits by regulatory authorities, this textis timely and an important contribution to the literature.The volume:* is written by well-known and experienced authors in thisarea* provides new approaches to major topics in clinical datamanagement* contains new chapters on systems software validation, databasedesign and performance measures.It will be invaluable to anyone in the field within thepharmaceutical industry, and to all biomedical professionalsworking in clinical research.
|Product dimensions:||6.16(w) x 9.19(h) x 1.01(d)|
Table of Contents
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 DatabaseEnvironment (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.
What People are Saying About This
"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#