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

  library.unc.edu

• Vital Signs

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

UNC NRP Resources

• UNC NRP Listerv Guidelines

  view pdf

FDA Resources

• Adverse Event Reporting to IRBs – Improving Human Subject Protection

  fda.gov/regulatory-information/search-fda-guidance-documents/adverse-event-reporting-irbs-improving-human-subject-protection
• Data Retention When Subjects Withdraw From FDA-regulated Clinical Trials

  fda.gov/regulatory-information/search-fda-guidance-documents/data-retention-when-subjects-withdraw-fda-regulated-clinical-trials
• Exception From Informed Consent Requirements for Emergency Research

  fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
• Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators

  fda.gov/regulatory-information/search-fda-guidance-documents/financial-disclosure-clinical-investigators
• Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

  fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects
• In Vitro Diagnostics (IVD) FAQs

  fda.gov/regulatory-information/search-fda-guidance-documents/in-vitro-diagnostic-ivd-device-studies-frequently-asked-questions
• IND Applications – Determining Whether Human Research Studies Can Be Conducted Without an IND

  fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-inds-determining-whether-human-research-studies-can-be
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

  fda.gov/regulatory-information/search-fda-guidance-documents/irb-responsibilities-reviewing-qualifications-investigators-adequacy-research-sites-and
• Medical Devices FAQs

  fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices
• Safety Reporting Requirements for IND and BA/BE Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe
• Significant Risk and Nonsignificant Risk Medical Device Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-risk-medical-device-studies
• Statement of Investigator (Form FDA 1572) FAQs

  fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-statement-investigator-form-fda-1572

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

• Association of Clinical Research Professionals (ACRP) Clinical Researcher

  acrpnet.org/insights/clinical-researcher

• Society of Clinical Research Associates (SOCRA)

  socra.org

• Regulatory Affairs Professionals Society (RAPS)

  raps.org