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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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Autore: Liu Margaret B. Visualizza persona
Titolo: A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / / Margaret B. Liu and Kate Davis Visualizza cluster
Pubblicazione: Chichester, [England] : , : Wiley-Blackwell, , 2010
©2010
Edizione: 2nd ed.
Descrizione fisica: 1 online resource (432 p.)
Disciplina: 615.5072/4
Soggetto topico: Clinical trials
Drugs - Testing
Persona (resp. second.): DavisKate (Kate G.)
Note generali: Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
Nota di contenuto: 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.
Titolo autorizzato: A clinical trials manual from the Duke Clinical Research Institute  Visualizza cluster
ISBN: 1-282-46164-8
9786612461644
1-4443-1522-6
1-4443-1521-8
1-4443-5788-3
Formato: Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione: Inglese
Record Nr.: 9910265229803321
Lo trovi qui: Univ. Federico II
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