A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /
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| Main Author: | |
|---|---|
| Corporate Author: | |
| Other Authors: | |
| Format: | Book |
| Language: | English |
| Published: |
Chichester, West Sussex, UK ; Hoboken, NJ :
Wiley-Blackwell,
2010.
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| Edition: | 2nd ed. |
| Subjects: | |
| Online Access: | Publisher description Table of contents only Contributor biographical information |
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| 100 | 1 | |a Liu, Margaret B. |9 3681 | |
| 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 xviii, 406 p. : |b ill. ; |c 25 cm. | ||
| 500 | |a STN.: 273/47 No.:01 FY:2072/73 Rev. ed. 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. | |
| 650 | 0 | |a Clinical trials |v Handbooks, manuals, etc. |9 3682 | |
| 650 | 0 | |a Drugs |x Testing |v Handbooks, manuals, etc. |9 3683 | |
| 650 | 1 | 2 | |a Clinical Trials as Topic |x legislation & jurisprudence |z United States. |9 3684 |
| 650 | 2 | 2 | |a Clinical Trials as Topic |x ethics |z United States. |9 3685 |
| 650 | 2 | 2 | |a Device Approval |z United States. |9 3686 |
| 650 | 2 | 2 | |a Drug Approval |z United States. |9 3687 |
| 700 | 1 | |a Davis, Kate |q (Kate G.) |9 3688 | |
| 700 | 1 | |a Liu, Margaret B. |t Lessons from a horse named Jim. |9 3689 | |
| 710 | 2 | |a Duke Clinical Research Institute. |9 3690 | |
| 856 | 4 | 2 | |3 Publisher description |u http://www.loc.gov/catdir/enhancements/fy0917/2009020427-d.html |
| 856 | 4 | 1 | |3 Table of contents only |u http://www.loc.gov/catdir/enhancements/fy0917/2009020427-t.html |
| 856 | 4 | 2 | |3 Contributor biographical information |u http://www.loc.gov/catdir/enhancements/fy0917/2009020427-b.html |
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