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Office of Regulatory Support

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.

Leaders

Joan E. Adamo, Ph.D., Director of the Office of Regulatory Support

 

 

Services & Support

We can help you navigate FDA-regulated processes, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.

 

Education & Career

The UR CTSI has launched a range of programs focused on advancing training, career development, and research in regulatory science.

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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John Miller presenting at the 2023 America's Got Regulatory Science Talent competition

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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