Clinical Research Operations

Service Description

PI Management of an ID

This form is used to request approval for a Principal Investigator (PI) to manage an investigational drug (ID) for a research study. While investigational drugs at UNC-Chapel Hill are typically managed by UNC Health’s Investigational Drug Services (IDS) Pharmacy, this request process applies to studies where the drug falls outside the scope of IDS policies.

If your study requires formal approval or an exemption from UNC Health IDS, please contact UNCIDS@unchealth.unc.edu before proceeding.

The information provided in this request will be used to determine whether the study may qualify for PI-led management of the investigational drug. Please note that submission does not guarantee approval.

Before submitting, please review the University of North Carolina at Chapel Hill Policy on Principal Investigator Oversight and Management of Investigational Drugs, which outlines when and how a PI may assume direct responsibility for investigational drug oversight.

Audience

UNC-Chapel Hill Faculty and Staff

Service Charges

Associated charges for investigational drug management will be discussed and communicated after the request has been reviewed and approved.

Support

For questions about this service, please contact OneUNCClinRes@unc.edu.

Documentation

University of North Carolina at Chapel Hill Policy on Principal Investigator Oversight and Management of Investigational Drugs

Drug Management Submission Pathway Decision Tree

Expected Delivery

5 Business Days