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Autore: | Liu Margaret B. |
Titolo: | A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / / Margaret B. Liu and Kate Davis |
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 |
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 |
Opac: | Controlla la disponibilità qui |