FDA Regulated Research Oversight Program

The Institute for Clinical and Translational Research (ICTR) and Office of the Vice Chancellor for Research and Graduate Education (OVCRGE) jointly created the FDA Regulated Research Oversight Program to promote and verify regulatory compliance.

This campus-wide undertaking aims to:

  • Create campus policy to ensure FDA-regulated research is conducted in accordance with federal regulations
  • Provide training for faculty who hold a FDA-issued investigational new drug (IND) or investigational device exemption (IDE), and
  • Assure timely and quality interactions with the FDA.

Please contact FDA-Regulated-Research-Oversight@lists.wisc.edu for additional information.

Click here to register a new IND/IDE or protocol with the Program.

Policies

All links to university-wide policies on this web page and on other pages of this website now take you directly to those policies in the new UW–Madison Policy Library at policy.wisc.edu. The new policy library brings all university-wide policies together in one place so you can quickly locate the most accurate, up-to-date version of a policy.

Visit the Policy Library to search for a specific policy by topic or key word(s).

Notification of FDA Inspection & External Audits
Policy summary: This policy outlines requirements for UW-Madison faculty and staff to notify campus officials of FDA inspections and other audits by external agencies, such as the National Institutes of Health.

Completion of Sponsor-Investigator Training
Policy summary: This policy sets standards for initial and ongoing training of UW-Madison personnel who hold an FDA-issued IND or IDE; and therefore, serve the dual role of “sponsor-investigators.”
• Instructions to Complete Training

Registration of Faculty Held INDs/IDEs

Policy summary: This policy outlines requirements for UW-Madison personnel to notify campus officials of IND/IDE submissions, closures, terminations and other activities.
• Link to IND/IDE and Protocol Registration Survey

Conduct of Routine Internal Reviews
Policy summary: This policy establishes a quality assurance system for research conducted under an investigator-held IND or IDE.

Contact

Tim Sparks

Position title: Scientific Director, FDA Regulated Research Oversight Program

Email: tim.sparks@wisc.edu

Jacob Rome

Position title: Administrative Director, FDA Regulated Research Oversight Program

Email: rome2@wisc.edu