Resources
UNC Resources
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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
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Vital Signs
A weekly newsletter produced by UNC Health and the UNC School of Medicine.
news.unchealthcare.org/vital-signs
UNC NRP Resources
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UNC NRP Listerv Guidelines
FDA Resources
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Adverse Event Reporting to IRBs – Improving Human Subject Protection
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Data Retention When Subjects Withdraw From FDA-regulated Clinical Trials
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Exception From Informed Consent Requirements for Emergency Research
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Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators
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Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
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In Vitro Diagnostics (IVD) FAQs
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IND Applications – Determining Whether Human Research Studies Can Be Conducted Without an IND
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Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
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IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
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Safety Reporting Requirements for IND and BA/BE Studies
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Significant Risk and Nonsignificant Risk Medical Device Studies
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Statement of Investigator (Form FDA 1572) FAQs
International Council for Harmonisation (ICH)
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ICH Website
Current ICH efficacy guidelines can be accessed directly from the ICH website, including:
- E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- E3: Clinical Study Reports
- E6: Good Clinical Practice
- E8: General Considerations for Clinical Trials
Other Resources
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Association of Clinical Research Professionals (ACRP) Clinical Researcher
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Society of Clinical Research Associates (SOCRA)
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Regulatory Affairs Professionals Society (RAPS)