TY  - BOOK
AU  - Liu,Margaret B.
AU  - Davis,Kate
AU  - Liu,Margaret B.
ED  - Duke Clinical Research Institute.
TI  - A clinical trials manual from the Duke Clinical Research Institute: lessons from a horse named Jim 
SN  - 9781405195157
AV  - R853.C55 L58 2010
U1  - 615.5072/4 22
PY  - 2010///
CY  - Chichester, West Sussex, UK, Hoboken, NJ
PB  - Wiley-Blackwell
KW  - Clinical trials
KW  - Handbooks, manuals, etc
KW  - Drugs
KW  - Testing
KW  - Clinical Trials as Topic
KW  - legislation & jurisprudence
KW  - United States
KW  - ethics
KW  - Device Approval
KW  - Drug Approval
N1  - 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
UR  - http://www.loc.gov/catdir/enhancements/fy0917/2009020427-d.html
UR  - http://www.loc.gov/catdir/enhancements/fy0917/2009020427-t.html
UR  - http://www.loc.gov/catdir/enhancements/fy0917/2009020427-b.html
ER  -