A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis.

Author
Liu, Margaret B. [Browse]
Format
Book
Language
English
Εdition
2nd ed.
Published/​Created
Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Description
xviii, 406 p. : ill. ; 25 cm.

Details

Subject(s)
Related name
Notes
Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Bibliographic references
Includes bibliographical references and index.
Contents
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.
ISBN
  • 9781405195157
  • 1405195150
LCCN
2009020427
OCLC
338289114
RCP
C - S

Supplementary Information