03005nam 22006134a 450 991096571070332120251017110156.00-309-17280-20-309-52024-X0-585-14261-0(CKB)110986584752810(EBL)3375557(SSID)ssj0000106903(PQKBManifestationID)11131790(PQKBTitleCode)TC0000106903(PQKBWorkID)10012316(PQKB)10106091(MiAaPQ)EBC3375557(Au-PeEL)EBL3375557(CaPaEBR)ebr10040974(OCoLC)830028287(DNLM)960781(BIP)53855527(BIP)5692371(EXLCZ)9911098658475281020000303d1999 uy 0engur|n|---|||||txtccrAssuring data quality and validity in clinical trials for regulatory decision making workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices /Jonathan R. Davis ... [et al.] editors1st ed.Washington, DC National Academy Pressc19991 online resource (88 p.)The compass seriesDescription based upon print version of record.0-309-06594-1 Includes bibliographical references (p. 75-76).Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and AcronymsIn an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.Compass series (Washington, D.C.)Clinical trialsQuality controlClinical trialsQuality control.615/.1Davis Jonathan R1805450Institute of Medicine (U.S.).Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.MiAaPQMiAaPQMiAaPQBOOK9910965710703321Assuring data quality and validity in clinical trials for regulatory decision making4446704UNINA