Princeton University Library Catalog

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
Published/​Created:
Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Εdition:
2nd ed.
Description:
xviii, 406 p. : ill. ; 25 cm.
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.
Subject(s):
ISBN:
  • 9781405195157
  • 1405195150
LCCN:
2009020427
OCLC:
338289114
Related name:
RCP:
C - S