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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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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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