Regulatory Mandates

The Human Subject Research Post-Approval Monitoring is governed by the following:

• The Belmont Report
   
• Code of Federal Regulations (CFR) governing human research
  
  
  • FDA 21 CFR 50 (Protection of Human Subjects)
  • FDA 21 CFR 54 (Financial Disclosure by Clinical Investigators)
  • FDA 21 CFR 56 (Institutional Review Boards)
  • FDA 21 CFR 312 (Investigational New Drug Application)
  • FDA 21 CFR 812 (Investigational Device Exemptions)
    
    
• DHHS 45 CFR 46 (The Common Rule)
  
  
• DHHS 45 CFR 164 (Health Insurance Portability and Accountability Act of 1996) (HIPAA)
• FDA Information Sheets
  
  
• ICH Good Clinical Practice (GCP) Guidelines