02494nam 2200541 450 991026522980332120230725061312.01-282-46164-897866124616441-4443-1522-61-4443-1521-81-4443-5788-3(CKB)3710000000496557(EBL)4041866(MiAaPQ)EBC477856(MiAaPQ)EBC4041866(OCoLC)587390577(EXLCZ)99371000000049655720160106h20102010 uy 0engur|n|---|||||rdacontentrdamediardacarrierA clinical trials manual from the Duke Clinical Research Institute lessons from a horse named Jim /Margaret B. Liu and Kate Davis2nd ed.Chichester, [England] :Wiley-Blackwell,2010.©20101 online resource (432 p.)Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.1-4051-9515-0 Includes bibliographical references at the end of each chapters and index.Lessons 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.Clinical trialsHandbooks, manuals, etcDrugsTestingHandbooks, manuals, etcClinical trialsDrugsTesting615.5072/4Liu Margaret B.521036Davis Kate(Kate G.),Duke Clinical Research Institute.MiAaPQMiAaPQMiAaPQBOOK9910265229803321A clinical trials manual from the Duke Clinical Research Institute1968264UNINA