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 Information Sheets
- 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
- 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