Body
University Policy
Title
University of North Carolina at Chapel Hill Policy on Principal Investigator Oversight and Management of Investigational Drugs
Introduction
Purpose
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 participant safety.
Scope
This Policy applies to all Covered Individuals involved in Clinical Investigations of Investigational Drugs at UNC-Chapel Hill.
Policy
Policy Statement
The PI is responsible for the full lifecycle management of an Investigational Drug, including accountability, storage, provisioning, administration, and return or disposal of the Investigational Drug.
A PI is eligible to directly manage an Investigational Drug only if all the following conditions are present:
- The Investigational Drug is provisioned in a UNC-Chapel Hill Facility.
- If the Principal Investigator (PI) is not the study sponsor, the sponsor must provide written agreement allowing the PI to oversee and manage the Investigational Drug.
- The Investigational Drug does not require specialized handling.
- The Investigational Drug is not an FDA- controlled substance.
- The PI demonstrates the ability to comply with the University’s Procedure on Investigational Drug Management.
Investigational Drug Management Request
If PI-led Investigational Drug management is eligible pursuant to the requirements of this policy, a formal PI Investigational Drug Management Request must be submitted to the Office of the Vice Chancellor for Research – Clinical Research Operations. The request will be reviewed by a convened committee. Approval, if granted, will be communicated directly to the PI.
All applicable laws, regulations and University policies governing investigational drug management will apply throughout the course of the clinical trial.
Compliance
PI-led Investigational Drug management is subject to periodic audits by the University Clinical Trials Quality Assurance (CTQA) Program. Noncompliance may result in corrective or disciplinary action, up to and including suspension of the investigation, loss of privileges for direct (or PI-led) Investigational Drug management, referral for disciplinary review, or reporting to regulatory agencies, in accordance with University policy.
Definitions
Clinical Investigation: Any experiment in which a drug is administered or dispensed to, or used involving, one or more human participants. For the purposes of this definition, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
Clinical Research Compliance Office (CRCO): The University office responsible for ensuring compliance with clinical research-related regulatory institutional, and sponsor requirements.
Clinical Trials Quality Assurance (CTQA) Program: A program within the CRCO that conducts routine and directed audits of clinical research.
Covered Individuals: University faculty, staff members, post-doctoral appointees, students, trainees, consultants, and any other individuals engaged in Clinical Investigations.
FDA-controlled substance: A drug or chemical regulated under the Controlled Substances Act (CSA), classified by the U.S. Drug Enforcement Administration (DEA) into Schedules I–V based on medical use, potential for abuse, and risk of dependence; subject to FDA oversight for approval, labeling, and use in clinical research.
Investigational Drug: A drug or biological product (including vaccines) that is studied in a clinical investigation.
Principal Investigator (PI): The individual responsible for the conduct of the clinical investigation (i.e., under whose immediate direction the Investigational Drug is administered or dispensed to a participant).
Provision: Includes all the steps involved in making the drug available to research participants, including regulatory approvals and oversight of packaging and labeling it appropriately, storing it under required conditions (e.g., refrigeration, protection from light), transporting it safely to the clinical site, tracking and documentation to ensure chain of custody and compliance, and inventory management to monitor usage, expiration, and return or disposal.
Specialized handling: Handling that requires specific procedures and conditions necessary to ensure the safety, efficacy, and regulatory compliance of drugs. This may include secure handling of hazardous and controlled substances, adherence to sterile compounding standards, or reconstitution of investigational drugs.
University Facilities: All buildings, structures, open space and other real property, and other physical facilities, interior and exterior, owned or leased by the University. This includes facilities where research may take place, including, but not limited to:
- UNC Faculty Physician Clinics
- School of Medicine Clinical & Translational Research Center (CTRC)
- Eastowne Clinical Research Unit
- UNC Horizons Program
- TEACCH Autism Program
- UNC Psychology and Neuroscience Community Clinic
This list is not exhaustive. Questions about facility eligibility should be directed to the Office of the Vice Chancellor for Research – Clinical Research Operations.
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contact
Name: Laura Viera
Unit: Office of the Vice Chancellor for Research – Clinical Research Operations
Email: laura_viera@med.unc.edu