02931nam 2200601 450 991014252990332120170816141846.097866105553520-470-85335-21-280-55535-10-470-35943-9(CKB)111056485556156(EBL)138339(OCoLC)437250155(SSID)ssj0000123510(PQKBManifestationID)11139383(PQKBTitleCode)TC0000123510(PQKBWorkID)10005861(PQKB)11226153(MiAaPQ)EBC138339(EXLCZ)9911105648555615620160815h20002000 uy 0engur|n|---|||||txtccrClinical data management /edited by Richard Rondel, Sheila Varley, Colin Webb2nd ed.Chichester, West Sussex, England :John Wiley & Sons, Ltd,2000.©20001 online resource (368 p.)Includes index.0-471-98329-2 0-470-84636-4 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 Environment14 Re-engineering the Clinical Data Management Process15 Working with Contract Research Organizations; 16 Data Management in Epidemiology and Pharmacoeconomics; 17 Future Revisited; IndexExtensively 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 sMedicineResearchData processingElectronic books.MedicineResearchData processing.610/.285615.19Rondel R. K.Varley S. A.Webb C. F.MiAaPQMiAaPQMiAaPQBOOK9910142529903321Clinical data management2139222UNINA