Useful Links
University of Virginia Websites
UVA Department of Pharmacy Investigational Drug Services
UVA Institutional Biosafety Committee (IBC)
UVA - Institutional Review Board for Health Sciences Research (IRB-HSR)
UVA Office of Sponsored Programs (OSP)
UVA School of Medicine Office of Grants and Contracts
University of Virginia Patent Foundation
UVA Vice President for Research and Graduate Studies
Non-UVA Websites
Certificate of Confidentiality
Federal Register A database of Federal Register documents provided by the National Archives and Records Administration
FDA (Food and Drug Administration) Agency of the U.S. Department of Health and Human Services
FDA (Food and Drug Administration) IRB Information Sheets
FDA (Food and Drug Administration) Forms
DHHS (Department of Health and Human Services)
International Conference on Harmonisation (ICH)
National Institutes of Health Grants & Funding Opportunities
NIH Grant Forms & Instructions
OHRP (Office for Human Research Protections) (formerly OPRR) U.S. Department of Health and Human Services
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Non-UVA Websites With Online Training Modules
National Institutes of Health Human Participant Protections Education for Research Teams An online training module sponsored by the NIH on the rights and welfare of human participants in research.
OHRP Human Subject Assurance Training
Resource Documents
Federal Register- 21CFR312: Investigational New Drug Applications Title 21, Chapter FDA, Part 312
Federal Register- 21CFR812: Investigational Device Exemptions Title 21, Chapter FDA, Part 812
OHRP IRB Guidebook Human Subject Protections
45 CFR Part 46-Code of Federal Regulations- Public Welfare: Protection of Human Subjects
Subpart A Federal Policy for the Protection of Human Subjects
Subpart B Additional Protections for Pregnant Women, Human Fetuses,
and Neonates Involved in Research
Subpart C Additional DHHS Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners as Subjects
Subpart D Additional DHHS Protections for Children Involved as
Subjects in Research
21 CFR Part 50- Protection of Human Subjects
21 CFR Part 56- Institutional Review Boards
Other Links
Association of Clinical Research Professionals
Society of Clinical Research Associates
