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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
- 作者： Liu, Margaret B.
- 其他作者：
- 出版： Chichester, West Sussex, UK ;Hoboken, NJ : Wiley-Blackwell c2010
- 主題： Clinical trials--Handbooks, manuals, etc , Drugs--Testing--Handbooks, manuals, etc , Clinical Trials as Topic--legislation & jurisprudence , Clinical Trials as Topic--ethics , Device Approval , Drug Approval
- 版本：2nd ed
- ISBN： 9781405195157 (pbk.) :: US$74.95 、 1405195150 (pbk.)
- 一般註：Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001 Includes bibliographical references and index
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讀者標籤：
- 系統號： 005184560 | 機讀編目格式
館藏資訊
內容註
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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