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100   $a20160815h20002000  uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aClinical data management /$fedited by Richard Rondel, Sheila Varley, Colin Webb
205   $a2nd ed.
210  1$aChichester, West Sussex, England :$cJohn Wiley & Sons, Ltd,$d2000.
210  4$dİ2000
215   $a1 online resource (368 p.)
300   $aIncludes index.
311   $a0-471-98329-2 
311   $a0-470-84636-4 
327   $aClinical 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
327   $a14 Re-engineering the Clinical Data Management Process15 Working with Contract Research Organizations; 16 Data Management in Epidemiology and Pharmacoeconomics; 17 Future Revisited; Index
330   $aExtensively 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 s
606   $aMedicine$xResearch$xData processing
608   $aElectronic books.
615  0$aMedicine$xResearch$xData processing.
676   $a610/.285
676   $a615.19
702   $aRondel$b R. K.
702   $aVarley$b S. A.
702   $aWebb$b C. F.
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910142529903321
996   $aClinical data management$92139222
997   $aUNINA