Search Results - [Dept. of Health and Human Services, Food and Drug Administration],
-
1
Information sheet guidance for institutional review boards and clinical investigators (frequently asked questions)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
2
Information sheet guidance for institutional review boards and clinical investigators (cooperative research)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
3
Information sheet guidance for institutional review boards and clinical investigators (non-local IRB review)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
4
Information sheet guidance for institutional review boards and clinical investigators (sponsor - investigator - IRB interrelationship)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
5
Information sheet guidance for institutional review boards and clinical investigators (acceptance of foreign clinical studies)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
6
Information sheet guidance for institutional review boards and clinical investigators (continuing review after study approval)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
7
Information sheet guidance for institutional review boards and clinical investigators (charging for investigational products)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
8
Information sheet guidance for institutional review boards and clinical investigators (recruiting study subjects)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
9
Information sheet guidance for institutional review boards and clinical investigators (payment to research subjects)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic Software eBook -
10
Information sheet guidance for institutional review boards and clinical investigators (screening tests prior to study enrollment)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
11
Information sheet guidance for institutional review boards and clinical investigators (a guide to informed consent)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
12
Information sheet guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
13
Information sheet guidance for institutional review boards and clinical investigators ("off-label" and investigational use of marketed drugs, biologics, and medical devices)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
14
Information sheet guidance for institutional review boards and clinical investigators (treatment use of investigational drugs)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic Software eBook -
15
Information sheet guidance for institutional review boards and clinical investigators (exception from informed consent for studies conducted in emergency settings; regulatory langu...
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 1998“…[U.S. Dept. of Health and Human Services, Food and Drug Administration],…”Description: 1 electronic text : HTML file.
Get full text
Full text
Government Document Electronic eBook -
16
Guidance for industry financial disclosure by clinical investigators
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2001“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,…”Description: 1 online resource.
Get full text
Full text
Government Document Electronic eBook -
17
Guidance for industry protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
Published: 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“…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,…”Description: 1 online resource (unpaged) : forms.
Get full text
Full text
Government Document Electronic eBook