Research Conduct and Compliance
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Regulatory
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Guidance Documents and Sample Forms
Pertinent Links
Regulatory Information
Food and Drug Administration
Title 21 CFR 11- Electronic records; electronic signature
Title 21 CFR 54 - Financial
d
isclosure by
c
linical
i
nvestigators
Title 21 CFR 50 Protection of human subjects - informed consent
Title 21 CFR 56 Institutional review boards
Title 21 CFR 312 - Investigational
n
ew
d
rugs
Title 21 CFR 314 - FDA approval to market a new drug
Title 21 CFR 600 - Biological
p
roducts
Title 21 CFR 601 - Licensing
Title 21 CFR 812
- Investigational
d
evices
Title 21 CFR 814 - Pre-market approvals (PMAs) of medical
devices
Good Clinical Practice: Consolidated Guidance
Miscellaneous
The Belmont Report
The Declaration of Helsinki
The Department of Health & Human Services
The National Institute of Health
HAZMAT Safety
Revised
10/24/2004
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