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This Standard is meant to provide the minimum expectations for users of the University of North Carolina at Chapel Hill’s Data Management System (“DMS”) for Clinical Research Administrative Data. This Standard is intended to further the University’s goals of providing DMS users with efficient and accurate administrative data and to promote legal and regulatory compliance.

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.

The purpose of this Policy is to set forth the requirements for extramural clinical activities occurring outside the Adams School of Dentistry. These activities include but are not limited to rotations, volunteer outreach clinics, private practice, externships, and international trips sponsored by student organizations.

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.

This policy sets expectations for on-campus clinical and off-campus clinical attendance as well as make-up procedures. Simulation experiences are considered clinical experiences so are also covered by this policy.

This Policy describes requirements and expectations for peer-to-peer encounters as a component of clinical training.

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 document describes the Adams School of Dentistry's policy on timely signature of Assessment of Clinical Experience (ACE) forms by attendings.