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Resources

UNC Resources

  • IRB / Office of Human Research Ethics (OHRE)

    Responsible for ethical and regulatory oversight of research at UNC that involves human subjects. OHRE supports and oversees the work of the Institutional Review Boards (IRBs).
    research.unc.edu/human-research-ethics

  • NC TraCS Institute

    A grant-funded institute founded as a service to the research community, guiding research staff through clinical trials and regulatory approval, all the way to implementation in patient care.
    tracs.unc.edu

  • One UNC Clinical Research

    A central hub for communication, infrastructure, systems, resources, standards, and policies to support human subjects research.
    clinicalresearch.unc.edu

  • Office of the Vice Chancellor for Research

    This office oversees, develops, and supports UNC’s $1 billion research enterprise.
    research.unc.edu

  • SOM Office of Research

    Develops and implements the strategic plan for research and enhances research infrastructure in the School of Medicine.
    med.unc.edu/oor

  • UNC Health Office of Clinical Research

    The Office of Clinical Research (OCR) serves as a centralized resource supporting research operations across UNC Health. They provide guidance on navigating the logistics of conducting research in collaboration with UNC Health locations.
    UNC Health Collaboration Request

  • University Libraries
  • Vital Signs

    A weekly newsletter produced by UNC Health and the UNC School of Medicine.
    news.unchealthcare.org/vital-signs


UNC NRP Resources

FDA Resources
International Council for Harmonisation (ICH)
  • ICH Website

    Current ICH efficacy guidelines can be accessed directly from the ICH website, including:

    1. E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
    2. E3: Clinical Study Reports
    3. E6: Good Clinical Practice
    4. E8: General Considerations for Clinical Trials

Other Resources