Core Clinical Research Policies, Standards and Procedures - Clinical Research Support Office (CRSO)

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

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

Type	Functional Area	Title	Applicability	Responsible Unit
University Policy	Research Conduct	Research Code of Conduct Policy	University	Office of the Vice Chancellor for Research
University Standard	Research Conduct	Research Code of Conduct Standard	University	Office of the Vice Chancellor for Research
University Policy	IRB and Human Research Ethics	Policy on Research Involving Human Participants	University	Office of the Vice Chancellor for Research
University Policy	Conflicts of Interest	Policy on Individual Conflicts of Interest and Commitment	University	Conflict of Interest Office
University Policy	Reporting - Wrongful conduct	Whistleblower Policy	University	Division of Institutional Integrity and Risk Management
University Policy	Research Misconduct	Responding to Allegations of Research Misconduct Policy	University	Office of the Vice Chancellor for Research
University Policy	Clinical Research Management	Managing Clinical Research Administrative Data Policy	University	Office of the Vice Chancellor for Research
University Standard	Clinical Research Management	Managing Clinical Research Administrative Data Standard	University	Office of the Vice Chancellor for Research
University Policy	Research Billing	Policy on Research Billing	University	Office of the Vice Chancellor for Research
University Policy	Records	Records Management Policy	University	University Libraries, University Archives & Records Management Services
University Policy	Records	Policy on Public Records Requests	University	University Communications
University Policy	Environmental Health and Safety	Biological Safety Manual	University	Environment, Health and Safety
University Policy	Environmental Health and Safety	Laboratory Safety Manual	University	Environment, Health and Safety
University Policy	Environmental Health and Safety	Laser Safety Manual	University	Environment, Health and Safety
University Policy	Environmental Health and Safety	Laboratory Safety Manual	University	Environment, Health and Safety
University Policy	HIPAA - Privacy	HIPAA Research Policy	University	Institutional Privacy Office
University Policy & Procedure	HIPAA - Privacy	HIPAA Training Policy and Procedure	University	Institutional Privacy Office
University Policy	HIPAA - Privacy	Privacy of Protected Health Information Policy	University	Institutional Privacy Office
University Policy	HIPAA - Privacy	Accessing, Inspecting and Obtaining a Copy of Protected Health Information (PHI)	University	Institutional Privacy Office
University Policy	HIPAA - Privacy	Accounting of Disclosures of Protected Health Information (PHI) Policy	University	Institutional Privacy Office
University Policy	HIPAA - Privacy	The "Minimum Necessary" Standard for Accessing, Disclosing and Requesting Protected Health Information	University	Institutional Privacy Office
University Procedure	HIPAA - Privacy	HIPAA Complaint Procedure for Protected Health Information (PHI)	University	Institutional Privacy Office
University Standard	HIPAA - Privacy	Standard on HIPAA Sanctions	University	Institutional Privacy Office
University Policy	Digital Accessibility	Digital Accessibility Policy	University	ITS, Digital Accessibility Office
University Standard	Digital Accessibility	Accessibility of Digital Content and Materials Standard	University	ITS, Digital Accessibility Office
University Standard	Digital Accessibility	Accessibility Standards for Procurement of Digital Content and Materials	University	ITS, Digital Accessibility Office
University Standard	Information Security	Information Classification Standard	University	Information Technology Services
University Standard	Information Technology	Information Technology Vendor Management Standard	University	Information Technology Services
University Standard	Information Security	Transmission of Sensitive Information Standard	University	Information Technology Services
University Policy	Information Security	Information Security Policy	University	Information Technology Services
University Standard	Information Security	Information Security Controls Standard	University	Information Technology Services
University Standard	Information Security	Information Security Incident Management Standard	University	Information Technology Services
University Policy	Information Technology	Information Technology Acceptable Use Policy	University	Information Technology Services
Policy	Information Security	School of Medicine: Policy on the Use of Computing Devices	School of Medicine	School of Medicine
University Standard	Sponsored Research	Office of Sponsored Programs Operating Standards	University	Office of Sponsored Programs
University Policy	Export Controls	Policy on Export Controls	University	Export Controls Office
University Policy	Technology Commercialization	Equity Acquisition in Technology Licensing Arrangements Policy	University	Office of Technology Commercialization
University Policy	Human Embryonic Stem Cells	University of North Carolina at Chapel Hill Policy on Use of Human Embryonic Stem Cells in Research	University	Office of the Vice Chancellor for Research
University Policy	Postdoctoral Scholars	Postdoctoral Scholar Policy	University	Office of Postdoctoral Affairs
University Policy	University Resources	Policy on Use of University Resources in Support of Entrepreneurial Activities	University	Office of the Vice Chancellor for Research
University Policy	University Resources	Standard on Use of University Resources in Support of Entrepreneurial Activities	University	Office of the Vice Chancellor for Research
University Policy	Reporting - Misuse of University Resources	Policy on Reporting Actual, Attempted, or Suspected Misuse of University Resources	University	Division of Institutional Integrity and Risk Management
University Policy	Policy	Policy on Policy	University	Ethics and Policy Office
University Procedure	Research Misconduct	Responding to Allegations of Research Misconduct Procedure	University	Office of the Vice Chancellor for Research
UNC Health Policy	Equity in Research	Equity in Research	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
UNC Health 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)
UNC Health Policy	Conflict of Interest	Institutional Conflicts of Interest	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
UNC Health Policy	Research Administration	Research Administration and Compliance	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, ROC, WAY	UNC Health Office of Research Support & Compliance (ORSC)
UNC Health Policy	Research Billing	Research Billing	UNCHCS - CAL, CHA, JOH, LEN, NAS, PAR, PN, REX, ROC, WAY	UNC Health Office of Research Support & Compliance (ORSC)
UNC Health 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)
UNC Health Policy	Research Training	Research Training	UNCHCS - CAL, CHA, JOH, NAS, PN, REX, WAY	UNC Health Office of Research Support & Compliance (ORSC)
UNC Health 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)
UNC Health Policy	Investigational Drug Services	Investigational Drug Services	UNC Health Care System (all owned and managed entities)	Pharmacy management
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0101: UNC-Chapel Hill Human Research Protections Program	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0201: Quality Assurance	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0301: Education & Training	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0401: Institutional Review Board	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0501: Human Subject Research Determination	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0601: Exempt Studies	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0701: IRB Review Process	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0801: Institution, Investigator, or Sponsor-Initiated Holds	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 0901: Multicenter Research and Reliance Process	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1001: Documentation of Records	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1101: Obtaining Informed Consent from Research Subjects	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1201: Vulnerable Subjects in Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1301: FDA-Regulated Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1401: Promptly Reportable Information	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1402: IRB Review of Promptly Reportable Information	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1501: Investigator Responsibilities	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1601: Sponsored Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1701: Participant Outreach	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1801: Health Insurance Portability and Accountability Act (HIPAA)	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 1901: Information Security	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2001: Research Supported by the Department of Defense (DoD)	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2101: Individual Conflict of Interest in Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2102: IRB Member and Consultant Conflict of Interest	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2103: Institutional Conflicts of Interest	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2200: U.S. Department of Justice Supported Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2201: Research Subject to the U.S. Environmental Protection Agency Regulations	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2301: Research Subject to US Department of Education Regulations	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2401: Research Subject to US Department of Energy Regulations	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2501: Case Reports Requiring IRB Review	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2601: Certificate of Confidentiality	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2701: Community Partnerships in Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2801: Data or Biological Sample Repositories	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 2901: Family History Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3001: Genetic and Stem Cell Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3101: Research in Educational Settings	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3201: Internet Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3301: Mandatory Reporting	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3401: Multi-Site Studies Where UNC-Chapel Hill is the Lead Site or Coordinating Center	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3501: Oral History	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3601: Pilot Studies	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3701: Qualitative Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3801: Research Involving Coded Private Information or Biological Specimens	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 3901: Research Involving Deception or Withholding of Information	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4001: Research Involving Potentially Addictive Substances	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4101: Research Involving Radiation	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4201: Research Using Existing Data and Materials	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4301: Review Involving Data from Voice, Video, Digital or Image Recordings	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4401: Survey Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4501: The UNC-Chapel Hill Students and Employees as Research Subjects	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4502: Self and Family Member Experimentation	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4601: Trainee or Student Research and Course Projects Involving Human Subjects	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4701: Transnational Research	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4801: Pregnancy Testing Requirements	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 4901: Management of Incidental Findings in Research Imaging	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 5001: Emergency Preparedness Plan for the HRPP	University	Office of Human Research Ethics
University Procedure	IRB and Human Research Ethics	Office of Human Research Ethics SOP 6001: Definitions	University	Office of Human Research Ethics
Unit Procedures - School of Medicine	Clinical Research Operations	Standard Operating Procedures	School of Medicine	School of Medicine
UNC Health Procedures	Investigational Drugs	UNC IDS SOP-13 Sponsor and study team expectations	University and UNC Health	UNC Health Investigational Drug Services
UNC Health Procedures	Investigational Drugs	UNC IDS SOP-14 Authorized Prescribers	University and UNC Health	UNC Health Investigational Drug Services
UNC Health Procedures	Clinical Research Operations	Standard Operating Procedures for Research	UNC Health Network Entities	UNC Health Office of Research Support & Compliance (ORSC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Adverse Weather Policy	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Collection of Urine Samples	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Documentation of Outpatient Care Activities	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Levels of Care	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	New User Orientation & Training	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Outpatient Check-in, Triage & Check-out	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Pediatric Phlebotomy	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Phlebotomy	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Scheduling Research Participants	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Specimen Processing & Use of Centrifuges	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Use of Specimen Storage Facilities	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Urine Dipstick Testing	University and UNC Health	Clinical and Translational Research Center (CTRC)
Unit Procedure - School of Medicine, NC TraCS	Clinical Research Operations	Urine Pregnancy	University and UNC Health	Clinical and Translational Research Center (CTRC)