MARC Record from Library of Congress

LEADER: 02194nam a22003858a 4500
001 2009020427
003 DLC
005 20090521100029.0
008 090515s2010 enk bf 001 0 eng
010 $a 2009020427
020 $a9781405195157
035 $a(DNLM)101505068
040 $aDNLM/DLC$cDLC
042 $apcc
050 00 $aR853.C55$bL58 2010
060 10 $aQV 733 AA1$bL783c 2010
082 00 $a615.5072/4$222
100 1 $aLiu, Margaret B.
245 12 $aA clinical trials manual from the Duke Clinical Research Institute :$blessons from a horse named Jim /$cMargaret B. Liu and Kate Davis.
250 $a2nd ed.
260 $aChichester, West Sussex ;$aHoboken, NJ :$bWiley-Blackwell,$c2010.
263 $a0912
300 $ap. ;$ccm.
500 $aRev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
504 $aIncludes bibliographical references and index.
505 0 $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 -- International issues regarding clinical trials.
650 0 $aClinical trials$vHandbooks, manuals, etc.
650 0 $aDrugs$xTesting$vHandbooks, manuals, etc.
650 12 $aClinical Trials as Topic$xlegislation & jurisprudence$zUnited States.
650 22 $aClinical Trials as Topic$xethics$zUnited States.
650 22 $aDevice Approval$zUnited States.
650 22 $aDrug Approval$zUnited States.
700 1 $aDavis, Kate$q(Kate G.)
700 1 $aLiu, Margaret B.$tLessons from a horse named Jim.
710 2 $aDuke Clinical Research Institute.