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Guidance for clinical investigators, institutional review boards, and sponsors [[electronic resource] ] : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations
| Guidance for clinical investigators, institutional review boards, and sponsors [[electronic resource] ] : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, , [2006] |
| Descrizione fisica | i, 9 pages : digital, PDF file |
| Soggetto topico |
Medical research personnel - Government policy - United States
Clinical trials - Government policy - United States Pediatrics - Research - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for clinical investigators, institutional review boards, and sponsors |
| Record Nr. | UNINA-9910698868803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
| Guidance for industry [[electronic resource] ] : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] |
| Descrizione fisica | 1 online resource (unpaged) : forms |
| Soggetto topico |
Human experimentation in 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 | Guidance for industry |
| Record Nr. | UNINA-9910699066103321 |
Guidance for industry [[electronic resource] ] : financial disclosure by clinical investigators
| Guidance for industry [[electronic resource] ] : financial disclosure by clinical investigators |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Financial disclosure - 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 | Guidance for industry |
| Record Nr. | UNINA-9910699059803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and clinical investigators [[electronic resource] ] : the use of clinical holds following clinical investigator misconduct
| Guidance for industry and clinical investigators [[electronic resource] ] : the use of clinical holds following clinical investigator misconduct |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2004] |
| Descrizione fisica | 8 pages : digital, PDF file |
| Soggetto topico |
Medical research personnel - Government policy - United States
Medicine - Research - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and clinical investigators |
| Record Nr. | UNINA-9910698837803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2004] | ||
| 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)
| 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)
| 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)
| 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)
| 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)
| 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)
| 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 | ||
| ||
Soggetto topico
-
Medical research personnel - Government policy - United States
(17)
- Institutional review boards (Medicine) - Government policy - United States (13)
- Human experimentation in medicine - Government policy - United States (3)
- Medicine, Experimental - Government policy - United States (3)
- Clinical trials - Government policy - United States (1)