Resources

• 21 CFR Part 11
• British Association of Research Quality Assurance
• Clinical Investigator Inspection List
• Data Protection in EU
• EC Internal Market - homepage
• EMEA - Entry page
• Europa - The European Union On-Line
• Europe & International GCP Organizations
• FDA Office of Regulatory Affairs
• Financial Disclosure by Clinical Investigators
• Guidances and Information Sheets, FDA-GCP
• MedWatch
• NIDPOE Letters
• Office for Civil Rights - Privacy of Health Records
• Office for Human Research Protections (OHRP)
• Office of GCP
• ORI - Office of Research Integrity
• Pharmacos - European Commission
• Public Health Service List of Investiators Subject to Administrative Action
• Title 18
• Title 45 CFR Part 46brProtection Of Human Subjects