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A clinical trials manual from the Duke Clinical Research Institute: lessons from a horse named Jim
2010, Wiley-Blackwell
in English
- 2nd ed.
1405195150 9781405195157
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Book Details
Table of 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
International issues regarding clinical trials.
Edition Notes
Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Includes bibliographical references and index.
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