Guidance for clinical investigators, sponsors, and IRBs [[electronic resource] ] : adverse event reporting to IRBs : improving human subject protection |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
Descrizione fisica | 1 online resource (6 pages) |
Soggetto topico |
Clinical trials - Reporting
Human experimentation in medicine Institutional review boards (Medicine) - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for clinical investigators, sponsors, and IRBs |
Record Nr. | UNINA-9910699066203321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : IRB review of stand-alone HIPAA authorizations under FDA regulations |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2003] |
Descrizione fisica | 1 online resource (10 pages) |
Soggetto topico | Institutional review boards (Medicine) - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910699050503321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2003] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for institutional review boards (IRBs) [[electronic resource] ] : frequently asked questions, IRB registration |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
Descrizione fisica | 1 online resource (7 pages) |
Soggetto topico | Institutional review boards (Medicine) - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for institutional review boards |
Record Nr. | UNINA-9910699066303321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (a guide to informed consent) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Informed consent (Medical law) - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698912503321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (charging for investigational products) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698919003321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (cooperative research) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Institutional review boards (Medicine) - Government policy - United States
Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698926203321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698911803321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (frequently asked questions) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Institutional review boards (Medicine) - Government policy - United States
Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698926303321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (acceptance of foreign clinical studies) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Clinical trials - Reporting - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698919203321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators ("off-label" and investigational use of marketed drugs, biologics, and medical devices) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698911403321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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