A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /
Liu, Margaret B.
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis. - 2nd ed. - Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010. - xviii, 406 p. : ill. ; 25 cm.
STN.: 273/47 No.:01 FY:2072/73 Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Includes bibliographical references 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.
9781405195157 1405195150
2009020427
GBA959709 bnb
101505068 DNLM 015292008 Uk
Clinical trials--Handbooks, manuals, etc.
Drugs--Testing--Handbooks, manuals, etc.
Clinical Trials as Topic--legislation & jurisprudence--United States.
Clinical Trials as Topic--ethics--United States.
Device Approval--United States.
Drug Approval--United States.
R853.C55 / L58 2010
615.5072/4
2010 B-988 QV 733 AA1 / L783c 2010
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis. - 2nd ed. - Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010. - xviii, 406 p. : ill. ; 25 cm.
STN.: 273/47 No.:01 FY:2072/73 Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Includes bibliographical references 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.
9781405195157 1405195150
2009020427
GBA959709 bnb
101505068 DNLM 015292008 Uk
Clinical trials--Handbooks, manuals, etc.
Drugs--Testing--Handbooks, manuals, etc.
Clinical Trials as Topic--legislation & jurisprudence--United States.
Clinical Trials as Topic--ethics--United States.
Device Approval--United States.
Drug Approval--United States.
R853.C55 / L58 2010
615.5072/4
2010 B-988 QV 733 AA1 / L783c 2010