A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /

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Bibliographic Details
Author / Creator:Liu, Margaret B.
Edition:2nd ed.
Imprint:Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Description:1 online resource (xviii, 406 pages) : illustrations
Language:English
Subject:
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/12751348
Hidden Bibliographic Details
Other uniform titles:Davis, Kate (Kate G.)
Liu, Margaret B. Lessons from a horse named Jim.
Other authors / contributors:Duke Clinical Research Institute.
ISBN:9781444315219
1444315218
9781444315226
1444315226
9781405195157
1405195150
1282461648
9781282461642
9786612461644
6612461640
1444357883
9781444357882
Digital file characteristics:data file
Notes:Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Includes bibliographical references and index.
Print version record.
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.
Other form:Print version: Liu, Margaret B. Clinical trials manual from the Duke Clinical Research Institute. 2nd ed. Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010 9781405195157
Standard no.:10.1002/9781444315219

MARC

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245 1 2 |a A clinical trials manual from the Duke Clinical Research Institute :  |b lessons from a horse named Jim /  |c Margaret B. Liu and Kate Davis. 
250 |a 2nd ed. 
260 |a Chichester, West Sussex, UK ;  |a Hoboken, NJ :  |b Wiley-Blackwell,  |c 2010. 
300 |a 1 online resource (xviii, 406 pages) :  |b illustrations 
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500 |a Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001. 
504 |a Includes bibliographical references and index. 
505 0 |a 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. 
520 |a 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. 
650 0 |a Clinical trials  |v Handbooks, manuals, etc. 
650 0 |a Drugs  |x Testing  |v Handbooks, manuals, etc. 
650 1 2 |a Clinical Trials as Topic  |x legislation & jurisprudence 
650 2 2 |a Clinical Trials as Topic  |x ethics 
650 2 2 |a Device Approval 
650 2 2 |a Drug Approval 
651 2 |a United States 
650 6 |a Études cliniques  |v Guides, manuels, etc. 
650 6 |a Médicaments  |x Essais cliniques  |v Guides, manuels, etc. 
650 7 |a HEALTH & FITNESS  |x Alternative Therapies.  |2 bisacsh 
650 7 |a MEDICAL  |x Healing.  |2 bisacsh 
650 7 |a HEALTH & FITNESS  |x Healing.  |2 bisacsh 
650 7 |a BODY, MIND & SPIRIT  |x Healing  |x General.  |2 bisacsh 
650 7 |a Clinical trials.  |2 fast  |0 (OCoLC)fst00864429 
650 7 |a Drugs  |x Testing.  |2 fast  |0 (OCoLC)fst00898940 
655 0 |a Handbooks, manuals, etc. 
655 4 |a Electronic books. 
655 7 |a Handbooks and manuals.  |2 fast  |0 (OCoLC)fst01423877 
700 1 |a Davis, Kate  |q (Kate G.) 
700 1 |a Liu, Margaret B.  |t Lessons from a horse named Jim. 
710 2 |a Duke Clinical Research Institute. 
776 0 8 |i Print version:  |a Liu, Margaret B.  |t Clinical trials manual from the Duke Clinical Research Institute.  |b 2nd ed.  |d Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010  |z 9781405195157  |w (DLC) 2009020427  |w (OCoLC)338289114 
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