- FDA Website
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Compliance Program 7348.001 Bioresearch Monitoring: Human Drugs In Vivo Bioequivalence
- Compliance Program 7348.808 Bioresearch Monitoring: Good Laboratory Practice
- Compliance Program 7348.809 Bioresearch Monitoring: Institutional Review Board
- Compliance Program 7348.810 Bioresearch Monitoring: Sponsors, Contract Research Organizations and Monitors
- Compliance Program 7348.811 Bioresearch Monitoring: Clinical Investigators
- ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports
- ICH E6: Good Clinical Practice: Consolidated Guidance
