Regulatory Affairs and Quality Assurance
The Research Regulatory and Quality Assurance (Reg/QA) team within the Office of Research Integrity and Compliance (ORIC) collaborates with the Office of Clinical and Community Trials, the Office of Research Development, and the research community to support compliance with federal regulations, institutional policies, and ethical standards.
Our Services
Regulatory Affairs: Regulatory Affairs provides guidance and support to investigators and research teams on the regulatory processes of research involving drugs, biologics, and medical devices to support compliance with regulatory requirements, including those set by the FDA, HHS, and the IRB.
Quality Assurance: Quality Assurance conducts internal research audits of human subject research, supports external Regulatory Agency research inspections, and otherwise provides QA support of the research community.
Meet Our Team
Erica Dahlmeier, MPH
Benjamin Lee, MPH
Amanda Stevens
Jaston Lewis
