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" A clinical trials manual from the Duke Clinical Research Institute : "
Margaret B. Liu and Kate Davis
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BL
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| Record Number
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664478
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| Doc. No
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dltt
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| Main Entry
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Liu, Margaret B
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| Title & Author
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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
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| Edition Statement
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2nd ed
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| Publication Statement
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Chichester, West Sussex, UK ;Hoboken, NJ :: Wiley-Blackwell,, 2010
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| Page. NO
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xviii, 406 p. :: ill. ;; 25 cm
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| ISBN
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9781405195157
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: 1405195150
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| Notes
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Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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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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| Subject
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Clinical trials, Handbooks, manuals, etc
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Drugs-- Testing, Handbooks, manuals, etc
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Clinical Trials as Topic-- legislation jurisprudence-- United States
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Clinical Trials as Topic-- ethics-- United States
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Device Approval-- United States
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Drug Approval-- United States
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| Dewey Classification
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615.5072/4
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| LC Classification
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R853.C55L58 2010
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| NLM classification
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2010 B-988
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QV 733 AA1L783c 2010
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| Added Entry
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Davis, Kate, (Kate G.)
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Liu, Margaret B.
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Duke Clinical Research Institute
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