Best Practices, Resources & Links

Links

UNC Clinical Trials Quality Assurance (CTQA) Regulatory Templates

research.unc.edu/clinical-trials/training/forms
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
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 Clinical Investigators, Sponsors, and IRBs

Statement of Investigator (Form FDA 1572) FAQs

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

fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices
Significant Risk and Nonsignificant Risk Medical Device Studies

fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-risk-medical-device-studies
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
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
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
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
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
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
In Vitro Diagnostics (IVD) FAQs

fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/guidance-industry-and-fda-staff-vitro-diagnostic-ivd-device-studies-frequently-asked-questions

International Council for Harmonisation (ICH)

ICH Website

ich.org/page/efficacy-guidelines
ICH E2A Expedited Safety Reporting

database.ich.org/sites/default/files/E2A_Guideline.pdf
ICH E3 Guideline for Industry: Structure and Content of Clinical Study Reports

fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-content-clinical-study-reports
ICH E6 Guideline for Good Clinical Practice

database.ich.org/sites/default/files/E6_R2_Addendum.pdf
ICH E8 General Considerations for Clinical Trials

database.ich.org/sites/default/files/E8_Guideline.pdf

Office of the Vice Chancellor for Research

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

Office of Research

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

Office of Research Support and Compliance

Oversees research collaborations with UNC Physicians Network and the UNC Health entities. If you are interested in working with or conducting research at any of these locations, this is the place to start.

Request for Project Collaboration: UNC Health Collaboration Survey.

General questions: ORSC@unchealth.unc.edu

Clinical Research Support Office (CRSO)

The central administrative office supporting all human subjects research across the School of Medicine. Visit med.unc.edu/crso.

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). Visit 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. Visit tracs.unc.edu.

Lib Guide

The UNC Health Sciences Library hosts a guide to help researchers find and share literature on methodology and evidence-based strategies for recruitment and retention.

View the guide: Engagement, Inclusion, Recruitment, and Retention in Research Studies

Research in Epic

Have a question or need something new in Epic: Submit a Service Request

Something is broken in Epic: Create an Incident

Need to speak with the Epic Training Team? Email them at epictraining@unchealth.unc.edu

Vital Signs

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

Research Matters

A blog from the UNC Vice Chancellor for Research. Visit research.unc.edu/about/administration/matters/.

Clinical Researcher

Contact Erika Hanami to read issues of the Clinical Researcher online. Access to the online edition is made possible through an arrangement with the journal publisher.