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.

Policies

Notification of FDA Inspection & External Audits
This policy requires 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
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.”
Training Instructions

Registration of Faculty Held INDs/IDEs
This policy requires UW-Madison personnel to notify campus officials of IND/IDE submissions, closures, terminations and other activities.
Registration Instructions

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

Contact

Tim Sparks

Scientific Director, FDA Regulated Research Oversight Program

tim.sparks@wisc.edu

Jacob Rome

Administrative Director, FDA Regulated Research Oversight Program

rome2@wisc.edu

Amy Remm

FDA Research Quality & Compliance Monitor

amy.remm@wisc.edu