Animal Care & Use Program oversees all research performed on animals at Duke.
- Institutional Animal Care & Use Committee (IACUC) ensures that animals in research are used appropriately and treated in accordance with the highest standards of humane care.
- Division of Laboratory Animal Resources (DLAR) provides quality care for laboratory animals at Duke and serves as a resource for investigators conducting animal research.
- Office of Animal Welfare Assurance (OAWA) supports animal-facilitated research program by providing administrative support for the IACUC, regulatory and funding agency interaction, protocol pre-review, compliance monitoring, and training for the research community.
The Duke Clinical Research Institute Regulatory team collects information about clinical trials from around the world and makes it available at https://www.nihcollaboratory.org/sites/cbyc/SitePages/Home.aspx(link is external). This information includes news, lists of governmental agencies and ethics committee information, submission requirements, and adverse event information.
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 firstname.lastname@example.org.
Duke Research Integrity Office provides services to faculty, staff, internal Duke offices, and external organizations to ensure quality review, management, and reporting of conflict of interest (COI) as appropriate.
The Office of Audit, Risk & Compliance (link is external) (OARC) provides expertise, consultation and assessment in matters of compliance and facilitates implementation of a "compliant culture." Conflict of Interest Policies outline the requirement the disclosure, review, and, where necessary, management of relationships that might be considered a conflict of interest (COI).
University Institutional Ethics and Compliance Program (IECP) coordinates and supports compliance efforts and offices across Duke University. The School of Medicine also operates a Compliance Office.
Institutional Review Board (IRB) reviews all research involving human subjects for the Duke University Schools of Medicine and Nursing, Duke Regional Hospital (formerly Durham Regional Hospital), Duke Raleigh Hospital, and Duke Primary Care.
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.
Stem Cell Research Oversight (SCRO) Committee reviews any protocols that include the use of human cells, human embryonic cells (hES), induced pluripotent cells (iPS) or tissue in research. SCRO review is conducted in addition to review by the IRB, IACUC, or Institutional Biosafety Committee (IBC).
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.