LEADER 02494nam 2200541 450 001 9910265229803321 005 20230725061312.0 010 $a1-282-46164-8 010 $a9786612461644 010 $a1-4443-1522-6 010 $a1-4443-1521-8 010 $a1-4443-5788-3 035 $a(CKB)3710000000496557 035 $a(EBL)4041866 035 $a(MiAaPQ)EBC477856 035 $a(MiAaPQ)EBC4041866 035 $a(OCoLC)587390577 035 $a(EXLCZ)993710000000496557 100 $a20160106h20102010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 12$aA clinical trials manual from the Duke Clinical Research Institute $elessons from a horse named Jim /$fMargaret B. Liu and Kate Davis 205 $a2nd ed. 210 1$aChichester, [England] :$cWiley-Blackwell,$d2010. 210 4$dİ2010 215 $a1 online resource (432 p.) 300 $aRev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001. 311 $a1-4051-9515-0 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aLessons from a horse named Jim and other events in history affecting the regulation of clinical research -- The process : developing new drugs, biologics, and devices -- Good clinical practice and the regulations -- Informed consent and the regulations -- Institutional review boards -- Adverse events and unanticipated problems involving risks to subjects and others -- Monitoring, audits, and inspections -- The principal investigator, the clinical research coordinator, and the study site -- The protocol -- Study feasibility : reviewing a specific protocol -- Study activities -- Study documents/essential documents -- Management of study drugs, biologics, and devices -- Managing clinical trial data -- Global health and international trials. 606 $aClinical trials$vHandbooks, manuals, etc 606 $aDrugs$xTesting$vHandbooks, manuals, etc 615 0$aClinical trials 615 0$aDrugs$xTesting 676 $a615.5072/4 700 $aLiu$b Margaret B.$0521036 702 $aDavis$b Kate$g(Kate G.), 712 02$aDuke Clinical Research Institute. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910265229803321 996 $aA clinical trials manual from the Duke Clinical Research Institute$91968264 997 $aUNINA