A clinical trials manual from the Duke Clinical Research Institute
Subtitle: lessons from a horse named Jim
By: Margaret B. Liu and Kate Davis.
Contributors: Davis, Kate; Liu, Margaret B.; Duke Clinical Research Institute.
Edition: 2nd ed.
Publisher: Wiley-Blackwell
Published: 2010
Place of publication: Chichester, West Sussex; Hoboken, NJ
Language: eng
ISBN-13: 9781405195157
Subjects: 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
Genres: Handbooks, manuals, etc
Notes: Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.

Includes bibliographical references and index.
Table of contents: title: Lessons from a horse named Jim and other events in history affecting the regulation of clinical research; title: The process : developing new drugs, biologics, and devices; title: Good clinical practice and the regulations; title: Informed consent and the regulations; title: Institutional review boards; title: Adverse events and unanticipated problems Involving risks to subjects and others; title: Monitoring, audits, and inspections; title: The principal investigator, the clinical research coordinator, and the study site; title: The protocol; title: Study feasibility : reviewing a specific protocol; title: Study activities; title: Study documents/essential documents; title: Management of study drugs, biologics, and devices; title: Managing clinical trial data; title: International issues regarding clinical trials.