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Record Nr. |
UNINA9910142529903321 |
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Titolo |
Clinical data management / / edited by Richard Rondel, Sheila Varley, Colin Webb |
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Pubbl/distr/stampa |
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Chichester, West Sussex, England : , : John Wiley & Sons, Ltd, , 2000 |
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©2000 |
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ISBN |
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9786610555352 |
0-470-85335-2 |
1-280-55535-1 |
0-470-35943-9 |
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Edizione |
[2nd ed.] |
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Descrizione fisica |
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1 online resource (368 p.) |
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Disciplina |
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Soggetti |
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Medicine - Research - Data processing |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Nota di contenuto |
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Clinical Data Management SECOND EDITION; Contents; Contributors; Foreword; Preface; 1 Chapter Review; 2 The International Conference on Harmonisation and its Impact; 3 Case Report Form Design; 4 Data Capture; 5 Planning and Implementation; 6 Data Validation; 7 Quality Assurance and Clinical Data Management; 8 Performance Measures; 9 Data Presentation; 10 Coding of Data-MedDRA and other Medical Terminologies; 11 Database Design Issues for Central Laboratories; 12 Computer Systems; 13 Systems Software Validation Issues-Clinical Trials Database Environment |
14 Re-engineering the Clinical Data Management Process15 Working with Contract Research Organizations; 16 Data Management in Epidemiology and Pharmacoeconomics; 17 Future Revisited; Index |
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Sommario/riassunto |
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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 |
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