Food and Drug Administration (FDA) - www.fda.gov

FDA History
http://www.fda.gov/AboutFDA/WhatWeDo/
History/default.htm

Good Clinical Practice in FDA-Regulated Clinical Trials
http://www.fda.gov/ScienceResearch/Special
Topics/RunningClinicalTrials/default.htm

FDA Guidance Documents
http://www.fda.gov/RegulatoryInformation/Guidances
/default.htm

Warning Letters
http://www.fda.gov/ICECI/Enforcement
Actions/WarningLetters/default.htm

21 Code of Federal Regulations
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/CFRSearch.cfm

http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200821

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulator yInformation/Guidances/ucm073122.pdf


International Conference on Harmonization (ICH) - http://www.ich.org


Good Clinical Practice (GCP) E6(R1)
http://www.ich.org/LOB/media/MEDIA482.pdf


Health Insurance Portability and Accountability Act (HIPAA or Privacy Rule)

National Institutes of Health HIPAA Privacy Rule Information for Researchers
http://privacyruleandresearch.nih.gov/