The Office of Regulatory Support (ORS) offers services to help investigators navigate and comply with a range of governing requirements. In addition to general assistance with requirements as they arise, we provide expertise to support specific FDA-regulated processes, including research involving experimental drugs and devices, as well as preclinical laboratory studies.
We can help you navigate FDA-regulated processes, including Investigational New Drug and Investigational Device Exemption applications and Expanded Access treatment uses.
The UR CTSI has launched a range of programs focused on advancing training, career development, and research in regulatory science.
Regulatory Affairs
The Office of Regulatory Support provides Regulatory Affairs support and services for Rochester faculty who are conducting research with FDA-regulated products. We aim to protect the safety of research participants and support investigators as they conduct high-quality research. To do this we provide a range of regulatory education, outreach, templates, and assistance to the entire research community. Our services provide regulatory support throughout the life cycle of a study from initial design through the conduct of the study to closing out and reporting results at the end. This assistance applies to investigational drugs, biologics, and medical devices used in the context of clinical research as well as non-FDA-approved therapeutics used for treatment purposes through the expanded access pathway.
Regulatory Science
Regulatory science is an area of study devoted to developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Learn about regulatory science-related education and training offered at the University of Rochester and our partner institutions, including formal degree programs, experiential training, and other educational resources.
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Research Spotlight
Students Tackle FDA Focus Areas in America’s Got Regulatory Science Talent Competition
Graduate students from across the University of Rochester presented their proposals to improve regulatory science as participants in the America’s Got Regulatory Science Talent Student Competition. Individuals and teams developed their proposals to address current FDA focus areas for regulatory science.
Resources
Federal Information Security Management Act
Under some federal contracts or grants, information the University collects or systems the University uses to store research results will need to comply with the Federal Information Security Management Act.
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Electronic Record Regulations
Regulations laid out in 21 CFR Part 11 assures the FDA that electronic research records contain the same information as would be found in paper records. If requested to provide documentation of compliance on this topic, email the Research Help Desk before signing anything.
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Process Improvement
A part of the Clinical Research Review Process Improvement Team, ORS staff engage across the University research community to identify system challenges and to coordinate development of system-wide solutions.
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