A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis.
Material type:![Text](/opac-tmpl/lib/famfamfam/BK.png)
- 9781405195157
- 1405195150
- 615.5072/4 22
- R853.C55 L58 2010
- 2010 B-988
- QV 733 AA1
Item type | Current library | Call number | Status | Date due | Barcode |
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Nepal Health Research Council Book Cart | QV 733 AA1/LIU/2010 (Browse shelf(Opens below)) | Available | 001985 |
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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.
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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