Links & Resources

University of Maryland Resources

• Human Research Protections Office (HRPO)
• Center for Clinical Trials
• Environmental Health and Safety
• Office of Research and Graduate Studies
• Office of Research Development
• Baltimore VA Medical Center
• School of Medicine Mentoring Program

Federal Regulations

• 45 CFR, Part 46, Protection of Human Subjects
• 21 CFR, Part 11 - Electronic Records; Electronic Signatures
• 21 CFR, Part 50 - Protection of Human Subjects
• 21 CFR, Part 54 - Financial Disclosure by Clinical Investigators
• 21 CFR, Part 56 - Institutional Review Boards
• 21 CFR, Part 312 - Investigational New Drug Application (IND)
• 21 CFR, Part 314 - Applications for FDA Approval to Market a New Drug (NDA)
• 21 CFR, Part 600 - Biological Products
• 21 CFR, Part 812 - Investigational Device Exemptions

Regulatory Guidance

• Belmont Report
• Guidance for Institutional Review Boards and Clinical Investigators
• FDA Drug Application Process (INDs)
• OHRP Policy Guidance
• Clinical Laboratory Improvement Amendments (CLIA)

Federal Agencies

• Office of Human Research Protection (OHRP)
• Food and Drug Administration (FDA)
• Office of Research Integrity (ORI)
• National Institutes for Health (NIH)
• Veterans Administration (VA)
• National Center for Research Resources (NCRR)

Good Clinical Practice

• Good Clinical Practice in FDA-Regulated Clinical Trials
• International Conference on Harmonisation (ICH) Guidelines

Other Resources

• RegSource (Free portal organizing worldwide Regulatory, Clinical, Toxicological, CMC and other drug/device development-related information on the Internet)
• ClinicalTrials.gov
• Certificates of Confidentiality
• Bioethics Resources
• The Hastings Center
• Public Responsibility in Medicine and Research (PRIM&R)  
• Agency for Healthcare Research and Quality (AHRQ)
• Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

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