02157nam 22005414a 450 991045612240332120200520144314.00-309-52024-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(EXLCZ)9911098658475281020000303d1999 uy 0engur|n|---|||||txtccrAssuring data quality and validity in clinical trials for regulatory decision making[electronic resource] workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices /Jonathan R. Davis ... [et al.] editorsWashington, 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 AcronymsCompass series (Washington, D.C.)Clinical trialsQuality controlElectronic books.Clinical trialsQuality control.615/.1Davis Jonathan R992810MiAaPQMiAaPQMiAaPQBOOK9910456122403321Assuring data quality and validity in clinical trials for regulatory decision making2480007UNINA