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Book Cover
Author Liu, Margaret B.

Title A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis
Edition Second edition
Published Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010
Online access available from:
Wiley Online Books    View Resource Record  


Description 1 online resource (xviii, 406 pages) : illustrations
Series Wiley SCELC e-books
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
Summary As the number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.: Includes a manual for investigators, research nurses and study coordinators with minimal exp
Notes Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Clinical Trials as Topic -- legislation & jurisprudence.
Clinical Trials as Topic -- ethics.
Device Approval.
Clinical trials -- Handbooks, manuals, etc.
Drug Approval.
Drugs -- Testing -- Handbooks, manuals, etc.
United States.
Genre/Form Handbooks and manuals.
Handbooks and manuals.
Form Electronic book
Author Davis, Kate (Kate G.)
Liu, Margaret B. Lessons from a horse named Jim
Duke Clinical Research Institute.
ISBN 1444315218
1444315226 (electronic bk.)
9781444315226 (electronic bk.)