Useful Links

Useful Links

University of Virginia Websites

UVA Office for Research

UVA - Clinical Trials

UVA Department of Pharmacy Investigational Drug Services

UVA Institutional Biosafety Committee (IBC)

UVA - Institutional Review Board for Health Sciences Research (IRB-HSR)

UVA - Lab Handbook

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

Clinical Trial Registry

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

FDA (Food and Drug Administration) Guidance for Institutional Review Boards, Clinical Investigators and Sponsors

DHHS (Department of Health and Human Services)

International Conference on Harmonisation (ICH)

National Institutes of Health

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)

National Cancer Institute

HIPPA

IND

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

Belmont Report

Declaration of Helsinki

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

Nuremberg Code

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

Drug Information Association

Society of Clinical Research Associates

CenterWatch Clinical Trials Listing Service

ClinicalTrials.gov