Policies, Procedures and Regulations
Policies and Procedures
- CTO Trial Start-Up Policies and Procedures
- Conduct of Clinical Research In VCU Health System Patient Care Areas
- ICH HARMONISED TRIPARTITE GUIDELINE Good Clinical Practices (GCP E6)
- VCU IRB Policies and Guidelines
- VCU Research Compliance Matrix
- VCU Study Site Policy and Procedure Templates (coming soon)
Regulations
Department of Human and Health Services
- DHHS 45 CFR Part 46
- Subpart A: Basic HHS Policy for Protection of Human Research Subject
- Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- Subpart D: Additional Protections for Children Involved as Subjects in Research
Food and Drug Administration
- FDA Regulations 21 CFR
