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Clinical Data Management (Hardcover)

by Richard K. Rondel (Editor), Sheila A. Varley (Editor), Colin F. Webb (Editor) "Despite the recent emphasis on electronic data capture tools, 95% of clinical data are still captured on paper and considerable resources are still applied to..." (more)
Key Phrases: clinical data management process, clinical data manager, management process flow, High Level Term, John Wiley, United States (more...)
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Editorial Reviews

Review
"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#

Product Description
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 is timely and an important contribution to the literature.

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.

It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

See all Editorial Reviews

Product Details
Inside This Book (learn more)
First Sentence:
Despite the recent emphasis on electronic data capture tools, 95% of clinical data are still captured on paper and considerable resources are still applied to achieving efficient design, production and distribution of CRFs. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
clinical data management process, clinical data manager, management process flow, solution development teams, data management staff, level group terms, medicinal product development, data management departments, clinical development process, remote data entry, data management team, data management groups, clinical trials laboratories, data management personnel, data validation process, form filler, contract research organisations, organ class, data management plans, investigator site, data management activities, data management function, final study report, clinical study report, adverse event data
Key Phrases - Capitalized Phrases (CAPs): (learn more)
High Level Term, John Wiley, United States, International Conference, High Level Group Term, Oracle Clinical, Patient Synopsis, European Union, John Johnson Week, New York, World Health Organisation, Computer Systems Validation, Effective March, Good Manufacturing Practice, Management Board, Queens University Belfast Publications, Statistical Considerations, Data Validation Steps Performed, Effective September, Medicines Control Agency
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