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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 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.

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 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 University of North Carolina at Chapel Hill is committed to combatting Human Trafficking. Federal law mandates that federal contractors and subcontractors maintain an anti-trafficking compliance program to qualify for certain federal funds and grants. This policy establishes a compliance plan and reporting requirements that meet federal standards.

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.

The UNC IRB has developed this SOP to describe a series of consistent, deliberate steps to mitigate fetal exposure to risk in clinical research studies among women of child-bearing potential (CBP).

Federal regulations and University of North Carolina at Chapel Hill (UNC-Chapel Hill) policies require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals, or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and UNC-Chapel Hill in violation of federal regulations.

A repository is a collection of data or biological specimens whose organizers: Receive data or specimens from multiple sources; Maintain the data or specimens over time; and Control access to and use of data or specimens by multiple individuals and/or for multiple purposes, which may evolve over time

The purpose of this SOP is to establish written requirements to ensure the University of North Carolina at Chapel Hill's compliance with U.S. Department of Education requirements regarding human subjects research.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) is committed to ensuring that educational opportunities are offered to research participants, prospective research participants, and community members which will enhance their understanding of research involving human participants at UNC-Chapel Hill and provide them the opportunity to provide input and express concerns. This procedure describes how UNC-Chapel Hill fulfills that responsibility.

Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

This policy establishes the Human Research Protection Program (HRPP) as the body responsible for ensuring UNC-Chapel Hill conducts human subjects research that is ethical and that complies with all relevant laws and regulations.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Justice requirements regarding human subjects research. This SOP specifies requirements for research supported by the National Institute of Justice and/or conducted within the Bureau of Prisons.