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Useful Links

Useful Links

Agency for Health Care Policy and Research
Applied Clinical Trials
Australian Commonwealth Department of Health and Family
Australian Institute of Health and Welfare
Belmont Report
Canadian Health Network
Canadian Regulations
Canadian Standards Council
Centerwatch Clinical Trials
Clinical Data Interchange Standards Consortium
Department of Health and Human Services
Declaration of Helsinki
GovInfo (U.S. Government Publications)
Ethics - Medical College of Wisconsin's Center for the Study of Bioethics
Ethics - NIEHS Research Ethics
FDA 21 CFR
FDA (Food and Drug Administration) - Main
FDA CBER (biologics)
FDA CDER (drugs)
FDA CDRH - CFR 21 (Food and Drugs)
FDA CDRH (devices & radiologies)
FDA Device
FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations (PDF)
FDA - ORA Compliance Program Guidance 7348.811 (Clinical Investigators)
FDA - ORA Compliance Program Guidance 7348.809 (Institutional Review Boards)
FDA - ORA Compliance Program Guidance 7348.810 (Sponsors, CROs, and Monitors)
FDA Small Business Representatives

Federal Register
Financial Times Healthcare
FOI - FDA Information and Documentation
Health Canada
ICH - International Council for Harmonization - Guidelines
MedDRA
MedDRA Dictionaries
Medical College of Wisconsin - Center for the Study of Bioethics
National Human Genome Research Institute
NC Regulatory Affairs Forum
NIEHS Research Ethics
NIH - National Institutes of Health
Nuremberg Code
OHRP - Office for Human Research Protection (formerly OPRR)
Pharmaceutical Online Home Page
PhRMA - Pharmaceutical Research & Manufacturers Association
Pharmatech
Regsource.com
Regulatory Affairs Professionals Society
Research Dynamics Consulting Group
Sunshine Behavioral Health - COVID 19 Resource Page
Tufts Center for the Study of Drug Development
Tuskegee University Bioethics
U.S. National Library of Medicine (NLM)
WHO - World Health Organization (Geneva)
WorldPharmaWeb - Pharmaceutical Business News

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