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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.

Public trust in the integrity and ethical behavior of scholars must be maintained if research is to continue to play its proper role in our University and society. While the primary responsibility for maintaining integrity in research rests with those who conduct it, the University has established standards to ensure a healthy environment for research and compliance with law.

This procedure explains how the University responds to allegations of Research Misconduct.

UNC-Chapel Hill is committed to protecting the integrity of its programs and activities and ensuring compliance with all applicable legal requirements and federal, sponsor, and University requirements, policies, standards, and procedures related to science and security, including research security (“Applicable Requirements”). This policy establishes the standards and structures necessary to safeguard University activities and maintain compliance.

The University recognizes the importance of providing flexibility for employees to balance work responsibilities with personal obligations and commitments. This policy outlines the regulations regarding flexible work arrangements (FWAs). Departments are encouraged to be open to allowing for FWAs with the understanding that this flexibility must still ensure appropriate employee accountability and be compatible with the operational needs of the work unit.

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.

The purpose of this policy is to ensure that the University is prepared for and can effectively respond to and recover from a Disaster or Emergency through the appropriate use of University and community resources. This preparation and effective response will mitigate the immediate and long-term effects on the University’s constituents, operations, and mission.

The standards and procedures in this document provide guidance to all researchers and animal handlers for performing blood withdrawals and tail biopsies in mice and rats.

This SOP provides examples and procedures for the reporting of Promptly Reportable Information (PRI) to the University of North Carolina at Chapel Hill's Institutional Review Board.

The University is committed to establishing a welcoming and equitable digital experience. This policy provides direction on creating an accessible experience that enhances usability for everyone. Implementing this policy will ensure that all individuals have access to Digital Content, Resources, and Technology (“Digital Material”) provided by or on behalf of the University.

This policy establishes the University of North Carolina at Chapel Hill ownership of Research Data. The University is obligated, by federal funding agency grant terms, federal and state regulations, policies, other contractual terms, and its mission statement, to ensure that research data and materials are secured and appropriately accessible.

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 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.

The University of North Carolina at Chapel Hill ("UNC") One Card is a multipurpose identification card that also serves as a card for library and meal plan use, building access, copy and print services and access to campus events. This Cardholder Agreement document explains how to get a One Card, how to report a lost or stolen One Card, and financial responsibilities that come with having a UNC One Card.

The standards described provide guidance to all researchers and animal handlers administering chemical agents, whether they be pharmaceutical or non-pharmaceutical grade.