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The policy defines the responsibilities of a UNC-Chapel Hill (“University”) Principal Investigator (“PI”) in the management of Investigational Drugs and establishes the specific circumstances under which a PI may directly manage Investigational Drugs in the conduct of a clinical trial.

This policy ensures alignment with applicable federal and state laws and regulations, accrediting agency standards, University policies, and sponsor requirements, to uphold research integrity and to ensure part

This Policy is meant to describe how the University of North Carolina at Chapel Hill manages Research Administrative Data for certain types of Clinical Research studies.

In general, an anecdotal report on one or a series of patients seen in one’s own practice and a comparison of these patients to existing reports in the literature is not research and does not require IRB approval. Going beyond one’s own practice to seek out and report cases seen by other clinicians creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and would require IRB approval.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Energy (DOE) requirements regarding human subjects research.

This SOP establishes the processes and procedures for ensuring the rights, safety, and welfare of research participants are protected when UNC-Chapel Hill shares responsibility for research oversight with another organization.

The policy establishes the requirements for using University-approved electronic research systems to obtain legally valid electronic signatures on essential documents for clinical research at the University of North Carolina at Chapel Hill (“University” or “UNC-Chapel Hill”). Its purpose is to ensure regulatory compliance, enhance efficiency, and improve oversight of electronic signatures in clinical research.

An “Institutional-, investigator- or sponsor-initiated hold” refers to a voluntary action by the institution, investigator or sponsor of the study to place some or all research activities associated with that study on hold. Institutional, investigator or sponsor holds may be the result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation, pre-planned stopping point or other information.

All research using human subjects must be approved by the University of North Carolina at Chapel Hill (UNC‐Chapel Hill). However, certain categories of human subject research are exempt from IRB approval. Exempt research is subject to review for determination of exemption status. At the UNC‐Chapel Hill exemptions are reviewed IRB Staff, and granted by an IRB Chair or designee.

All non‐exempt human subjects research must be reviewed by the IRB. The first step in determining whether research must be reviewed is to determine whether it meets the regulatory definition of human subject research.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) performs Quality Assurance and Improvement activities for the purposes of monitoring the safety of ongoing studies and measuring and improving human research protection effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.

The University of North Carolina at Chapel Hill (UNC‐Chapel Hill) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Organization.

The University of North Carolina at Chapel Hill adopts this policy in order to disseminate the fruits of its research and scholarship as widely as possible.

The University of North Carolina at Chapel Hill is committed to promoting energy efficiency and conservation to benefit students, faculty, staff and the campus community. Beyond reducing utility bills, careful energy management helps protect the environment and extends the life of equipment while also maintaining a comfortable setting in which to learn, teach and work.