This policy defines the authority of the Clinical Research Compliance Office (CRCO) in:Determining whether current Good Manufacturing Practices (cGMP) requirements apply to a given project or activity; Overseeing cGMP compliance in all applicable scenarios; and Exercising signature authority for Quality Agreements and similar research agreements related to quality expectations and regulatory compliance pertaining to cGMP activities.
This document establishes a uniform policy for billing of procedures, items, or tests provided to participants who participate in clinical research studies to ensure compliance with federal, state, and institutional guidelines. This policy supplements existing policies related to the conduct of clinical research studies. This policy is applicable to medical items or services provided as part of a clinical research study; however, it does not apply to studies that do not involve human subjects.
This policy outlines the requirements for the delegation of Clinical Tasks to personnel in the conduct of Clinical Research within the University of North Carolina at Chapel Hill facilities. It ensures that individuals to whom Clinical Tasks are delegated for Clinical Research purposes are appropriately licensed, qualified, and trained for their specific responsibilities.
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.
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.
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
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.