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Record Nr. |
UNINA9910467635603321 |
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Autore |
Ellenberg Susan Smith |
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Titolo |
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets |
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Pubbl/distr/stampa |
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Hoboken, NJ : , : Wiley, , 2019 |
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ISBN |
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1-119-51268-9 |
1-119-51264-6 |
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Edizione |
[Second edition.] |
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Descrizione fisica |
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1 online resource (493 pages) |
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Collana |
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Disciplina |
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Soggetti |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs. |
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