Clinical Research Policy Matrices

The two matrices below identify core clinical research policies, standards, and procedures that pertains to UNC-Chapel Hill (“University”) and UNC Health.

Note: While the matrices offer a comprehensive compilation of policies, standards and procedures, it is not exhaustive.

The policies, standards, and procedures are organized by the following headers: type, functional area, title, applicability, and responsible unit. You can browse the matrix or narrow your search by filtering on the headers or searching by keywords.

A good way to start is to search the matrix by keyword – If you add the word “billing” to the search bar, the matrix displays any policies, standards, or procedures that include “billing” in the header text. You may also search the University Electronic Policy Repository or UNC Health Policy Stat directly via the direct links included.

Scope	Type	Category	Title	Responsible Unit
Unit	Procedure	Clinical Research Operations	Standard Operating Procedures	School of Medicine
Unit	Procedure	Clinical Research Operations	Adverse Weather Policy	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Collection of Urine Samples	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Documentation of Outpatient Care Activities	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Levels of Care	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	New User Orientation & Training	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Outpatient Check-in, Triage & Check-out	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Pediatric Phlebotomy	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Phlebotomy	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Scheduling Research Participants	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Specimen Processing & Use of Centrifuges	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Use of Specimen Storage Facilities	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Urine Dipstick Testing	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Procedure	Clinical Research Operations	Urine Pregnancy	NC TraCS, Clinical and Translational Research Center (CTRC)
Unit	Policy	Computing	School of Medicine: Policy on the Use of Computing Devices	School of Medicine
University	Policy	Data Management	Managing Clinical Research Administrative Data Policy	Office of the Vice Chancellor for Research
University	Policy/Procedure	Conflicts of Interest	Policy on Individual Conflicts of Interest and Commitment	Conflict of Interest Office
University	Policy/Procedure	Conflicts of Interest	Policy on Institutional Conflict of Interest	Conflict of Interest Office
University	Policy	Data Management	Policy on Research Data Ownership	Office of the Vice Chancellor for Research
University	Policy	Digital Accessibility	Digital Accessibility Policy	ITS, Digital Accessibility Office
University	Standard	Data Management	Managing Clinical Research Administrative Data Standard	Office of the Vice Chancellor for Research
University	Standard	Digital Accessibility	Accessibility of Digital Content and Materials Standard	ITS, Digital Accessibility Office
University	Policy	Environmental Health and Safety	Biological Safety Manual	Environment, Health and Safety
University	Policy	Environmental Health and Safety	Laboratory Safety Manual	Environment, Health and Safety
University	Policy	Environmental Health and Safety	Laser Safety Manual	Environment, Health and Safety
University	Policy	Environmental Health and Safety	Laboratory Safety Manual	Environment, Health and Safety
University	Policy	Export Controls	Policy on Export Controls	Export Controls Office
University	Policy	HIPAA - Privacy	Privacy of Protected Health Information Policy	Institutional Privacy Office
University	Policy	HIPAA - Privacy	Accessing, Inspecting and Obtaining a Copy of Protected Health Information (PHI)	Institutional Privacy Office
University	Policy	HIPAA - Privacy	Accounting of Disclosures of Protected Health Information (PHI) Policy	Institutional Privacy Office
University	Policy	HIPAA - Privacy	The "Minimum Necessary" Standard for Accessing, Disclosing and Requesting Protected Health Information	Institutional Privacy Office
University	Policy	HIPAA - Privacy	HIPAA Research Policy	Institutional Privacy Office
University	Policy	Special Research Area	University of North Carolina at Chapel Hill Policy on Use of Human Embryonic Stem Cells in Research	Office of the Vice Chancellor for Research
University	Policy	Human Research Protection	Policy on Research Involving Human Participants	Office of the Vice Chancellor for Research
University	Policy	Information Security	Information Security Policy	Information Technology Services
University	Policy	Information Technology	Information Technology Acceptable Use Policy	Information Technology Services
University	Policy	Policy	Policy on Policy	Ethics and Policy Office
University	Policy	Special Research Area	Postdoctoral Scholar Policy	Office of Postdoctoral Affairs
University	Policy	Records	Records Management Policy	University Libraries, University Archives & Records Management Services
University	Policy	Records	Policy on Public Records Requests	University Communications
University	Policy	University Resources	Policy on Reporting Actual, Attempted, or Suspected Misuse of University Resources	Division of Institutional Integrity and Risk Management
University	Policy	Clinical Research Billing	Policy on Research Billing	Office of the Vice Chancellor for Research
University	Policy	Research Integrity and Reporting	Research Code of Conduct Policy	Office of the Vice Chancellor for Research
University	Policy	Research Integrity and Reporting	Responding to Allegations of Research Misconduct Policy	Office of the Vice Chancellor for Research
University	Policy	Research Integrity and Reporting	Whistleblower Policy	Division of Institutional Integrity and Risk Management
University	Policy	Technology	Equity Acquisition in Technology Licensing Arrangements Policy	Office of Technology Commercialization
University	Policy	University Resources	Policy on Use of University Resources in Support of Entrepreneurial Activities	Office of the Vice Chancellor for Research
University	Policy	University Resources	Standard on Use of University Resources in Support of Entrepreneurial Activities	Office of the Vice Chancellor for Research
University	Policy/Procedure	HIPAA - Privacy	HIPAA Training Policy and Procedure	Institutional Privacy Office
University	Procedure	HIPAA - Privacy	HIPAA Complaint Procedure for Protected Health Information (PHI)	Institutional Privacy Office
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0101: UNC-Chapel Hill Human Research Protections Program	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0201: Quality Assurance	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0301: Education & Training	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0401: Institutional Review Board	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0501: Human Subject Research Determination	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0601: Exempt Studies	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0701: IRB Review Process	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0801: Institution, Investigator, or Sponsor-Initiated Holds	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 0901: Multicenter Research and Reliance Process	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1001: Documentation of Records	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1101: Obtaining Informed Consent from Research Subjects	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1201: Vulnerable Subjects in Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1301: FDA-Regulated Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1401: Promptly Reportable Information	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1402: IRB Review of Promptly Reportable Information	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1501: Investigator Responsibilities	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1601: Sponsored Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1701: Participant Outreach	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1801: Health Insurance Portability and Accountability Act (HIPAA)	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 1901: Information Security	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2001: Research Supported by the Department of Defense (DoD)	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2101: Individual Conflict of Interest in Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2102: IRB Member and Consultant Conflict of Interest	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2103: Institutional Conflicts of Interest	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2200: U.S. Department of Justice Supported Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2201: Research Subject to the U.S. Environmental Protection Agency Regulations	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2301: Research Subject to US Department of Education Regulations	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2401: Research Subject to US Department of Energy Regulations	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2501: Case Reports Requiring IRB Review	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2601: Certificate of Confidentiality	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2701: Community Partnerships in Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2801: Data or Biological Sample Repositories	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 2901: Family History Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3001: Genetic and Stem Cell Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3101: Research in Educational Settings	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3201: Internet Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3301: Mandatory Reporting	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3401: Multi-Site Studies Where UNC-Chapel Hill is the Lead Site or Coordinating Center	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3501: Oral History	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3601: Pilot Studies	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3701: Qualitative Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3801: Research Involving Coded Private Information or Biological Specimens	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 3901: Research Involving Deception or Withholding of Information	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4001: Research Involving Potentially Addictive Substances	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4101: Research Involving Radiation	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4201: Research Using Existing Data and Materials	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4301: Review Involving Data from Voice, Video, Digital or Image Recordings	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4401: Survey Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4501: The UNC-Chapel Hill Students and Employees as Research Subjects	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4502: Self and Family Member Experimentation	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4601: Trainee or Student Research and Course Projects Involving Human Subjects	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4701: Transnational Research	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4801: Pregnancy Testing Requirements	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 4901: Management of Incidental Findings in Research Imaging	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 5001: Emergency Preparedness Plan for the HRPP	Office of Human Research Ethics
University	Procedure	Human Research Protection	Office of Human Research Ethics SOP 6001: Definitions	Office of Human Research Ethics
University	Procedure	Research Integrity and Reporting	Responding to Allegations of Research Misconduct Procedure	Office of the Vice Chancellor for Research
University	Standard	Digital Accessibility	Accessibility Standards for Procurement of Digital Content and Materials	ITS, Digital Accessibility Office
University	Standard	HIPAA - Privacy	Standard on HIPAA Sanctions	Institutional Privacy Office
University	Standard	Information Security	Information Classification Standard	Information Technology Services
University	Standard	Information Security	Transmission of Sensitive Information Standard	Information Technology Services
University	Standard	Information Security	Information Security Controls Standard	Information Technology Services
University	Standard	Information Security	Information Security Incident Management Standard	Information Technology Services
University	Standard	Information Technology	Information Technology Vendor Management Standard	Information Technology Services
University	Standard	Research Integrity and Reporting	Research Code of Conduct Standard	Office of the Vice Chancellor for Research
University	Standard	Sponsored Research	Office of Sponsored Programs Operating Standards	Office of Sponsored Programs
University	Policy	Records	Use of Electronic Signatures for Essential Documents in Clinical Research Policy	Office of the Vice Chancellor for Research
University	Policy	International Research	Combating Human Trafficking in Global Research Policy	Office of the Vice Chancellor for Research

Type	Category	Title	Applicability	Responsible Unit
Policy	Equity in Research	Equity in Research	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Conflict of Interest	Individual Conflicts of Interest and Commitment	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Conflict of Interest	Institutional Conflicts of Interest	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Research Administration	Research Administration and Compliance	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, ROC, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Research Billing	Research Billing	UNCHCS - CAL, CHA, JOH, LEN, NAS, PAR, PN, REX, ROC, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Research Billing	Research Billing Compliance: Investigational Products	UNCHCS - CAL, CHA, JOH, MC, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Research Training	Research Training	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Epic	Second Sign for Research Orders in Epic	UNC Health Care System (all owned and managed entities)	UNC Health Office of Research Support & Compliance (ORSC)
Policy	Investigational Drug Services	Investigational Drug Services	UNC Health Care System (all owned and managed entities)	Pharmacy management
Procedure	Investigational Drugs	UNC IDS SOP-13 Sponsor and study team expectations	University and UNC Health	UNC Health Investigational Drug Services
Procedure	Investigational Drugs	UNC IDS SOP-14 Authorized Prescribers	University and UNC Health	UNC Health Investigational Drug Services
Procedure	Clinical Research Operations	Standard Operating Procedures for Research	UNC Health Network Entities	UNC Health Office of Research Support & Compliance (ORSC)

Clinical Research Policy Matrices

UNC-Chapel Hill (“University”) Policy Documents

UNC Health Policy Documents