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Contact us:

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130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax

Links

• UNC Policies and Guidelines
• UNC Offices, Labs, and Links
• Federal Websites
• Federal Regulations
• Federal Guidelines
• Associations
• Other Resources

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UNC Policies and Guidelines

• Policies on Research at Carolina
  • Responsible Conduct of Research Brochure (PDF)
• Human Subjects Protection
  • Contact the IRBs or Office of Human Research Ethics
  • OSR Human Subs Certification Database
• Facilities & Administrative (F&A) Policy
  • UNC Notice of Implementation of F&A Rates
• OCT's Quick Reference Guide

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UNC Offices, Labs, and Links

• Office of Sponsored Research
• Environment, Health and Safety
• RAMSeS Grant, Contract, or Cooperative Agreement Submission System
• ATN Computer Training
• UNC Healthcare
• UNC School of Medicine
  • General Clinical Research Center (GCRC)
• McClendon Clinical Laboratories: normal lab values
• Clinical Research Coordinators Group
• Research Administration Support Group
• Investigational Drug Service

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Federal Websites

• National Institutes of Health
• Office for Human Research Protections (OHRP)
• PHS Office of Scientific Integrity
• Food and Drug Administration
  • Center for Drug Evaluation and Research

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Federal Regulations

• 45 CFR 46: Protection of Human Subjects (NIH)
• 42 CFR Part 50, Subpart A: Scientific Misconduct Regulations
• 21 CFR 312: Investigational New Drug Application
• 21 CFR 314: FDA Approval to Market a New Drug
• 21 CFR 11: Electronic Records, Signatures
• 21 CFR 50: Protection of Human Subjects (FDA)
• 21 CFR 54: Financial Disclosure
• 21 CFR 56: Institutional Review Boards
• 21 CFR 812: Medical Devices

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Federal Guidelines

• Guidance for Industry Good Clinical Practice (FDA)
• Information for Clinical Investigators (FDA)
• The Belmont Report: Ethical Principles & Guidelines for Protection of Human Subjects

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Associations

• Association for Clinical Research Professionals
• Drug Information Association
• Society of Clinical Research Associates (SoCRA)

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Other Resources

• Centerwatch
• Barnett International

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Updated Friday, November 13, 2009.
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