LEADER 02282nam 22005534a 450 001 9910778746103321 005 20230422031329.0 010 $a0-309-17280-2 010 $a0-309-52024-X 010 $a0-585-14261-0 035 $a(CKB)110986584752810 035 $a(EBL)3375557 035 $a(SSID)ssj0000106903 035 $a(PQKBManifestationID)11131790 035 $a(PQKBTitleCode)TC0000106903 035 $a(PQKBWorkID)10012316 035 $a(PQKB)10106091 035 $a(MiAaPQ)EBC3375557 035 $a(Au-PeEL)EBL3375557 035 $a(CaPaEBR)ebr10040974 035 $a(OCoLC)830028287 035 $a(EXLCZ)99110986584752810 100 $a20000303d1999 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aAssuring data quality and validity in clinical trials for regulatory decision making$b[electronic resource] $eworkshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices /$fJonathan R. Davis ... [et al.] editors 210 $aWashington, DC $cNational Academy Press$dc1999 215 $a1 online resource (88 p.) 225 1 $aThe compass series 300 $aDescription based upon print version of record. 311 $a0-309-06594-1 320 $aIncludes bibliographical references (p. 75-76). 327 $aFront Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms 410 0$aCompass series (Washington, D.C.) 606 $aClinical trials$xQuality control 615 0$aClinical trials$xQuality control. 676 $a615/.1 701 $aDavis$b Jonathan R$01474203 712 02$aInstitute of Medicine (U.S.).$bRoundtable on Research and Development of Drugs, Biologics, and Medical Devices. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910778746103321 996 $aAssuring data quality and validity in clinical trials for regulatory decision making$93687739 997 $aUNINA