Regulatory, Ethics and Compliance Resources

Animal Care & Use Program

Animal Care & Use Program oversees all research performed on animals at Duke.

Office of Regulatory Affairs and Quality

Office of Regulatory Affairs and Quality  provides regulatory guidance from preclinical requirements to first-in-human studies and beyond. The group serves as a no-cost resource to regulatory strategy development, IND/IDE preparation and maintenance, GCP/GLP/GMP requirements, and interfacing with regulatory authorities, such as the FDA. The regulatory affairs group also offers educational opportunities and internships. This office is part of the School of Medicine and is partially supported by the Duke CTSA grant.

For more information, contact Amanda Parrish, director of regulatory affairs and quality, at (919) 668-8772 or amanda.b.parrish@duke.edu.

Research Costing Compliance (RCC)

Research Costing Compliance (RCC) is a team of people who manage financial research compliance at Duke. RCC provides oversight and guidance to the university research community in the management of sponsored projects funding and the interpretation and communication of policy.

MasterControl

MasterControl is a web-based quality management system (QMS). It is typically used as the master repository for all versions of SOPs and other documents, as well as for workflow and training management. MasterControl complies with FDA regulations (such as 21 CFR Part 11) and GMP standards. Use of MasterControl requires a license and ongoing maintenance fees.  Quick reference cards and training resources for Duke uses can be found here.