Investigator Resources
GCRC Resources
GCRC Application
Education and Training
GCRC Forms
Useful Research Links
University of Maryland Resources
- Human Research Protections Office (HRPO)
- Center for Clinical Trials
- Environmental Health and Safety
- Office of Research
- 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)