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

By: Liu, Margaret BContributor(s): Davis, Kate (Kate G.) | Liu, Margaret B. Lessons from a horse named Jim | Duke Clinical Research InstituteMaterial type: TextTextReference number:015292008Publication details: Oxford : Wiley-Blackwell, 2010. Edition: 2nd edDescription: xviii, 406 p. : ill. ; 25 cmISBN: 9781405195157 (pbk.) :; 1405195150 (pbk.) :Subject(s): 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 StatesDDC classification: 615.50724 LOC classification: R853.C55 | L58 2010Online resources: Publisher description | Table of contents only | Contributor biographical information
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.
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Item type Current library Class number Status Date due Barcode Item reservations
Book Book Main Library 615.50724 (Browse shelf(Opens below)) Available
Book Book Main Library 615.50724 (Browse shelf(Opens below)) Available
Book Book Main Library 615.50724 (Browse shelf(Opens below)) Available
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Formerly CIP. Uk

Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.

Includes bibliographical references and index.

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.

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