FDA Regulated Research Oversight Program

FDA Regulated Research Oversight Program

The FDA Regulated Research Oversight Program, a partnership between the UW Clinical Research Office, the Office of the Vice Chancellor for Research and Graduate Education (OVCRGE), and the Institute for Clinical and Translational Research (ICTR), was created 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 an FDA-issued investigational new drug (IND) or investigational device exemption (IDE)
    • Assure timely and quality interactions with the FDA

 

Please Contact Us 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 yo those policies in the new UW–Madison Policy Library. The 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 keyword(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 (NIH).

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”.

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.

Conduct of Routine Internal Reviews

Policy Summary: This policy establishes a quality assurance system for research conducted under an investigator-held IND or IDE.

Guidance Documents

Industry FDA 483 Requests Guidance

Study Sponsor Requests for Information and Materials Related to FDA Audits

Study sponsors sometimes request information about whether UW-Madison, its IRBs, or a particular investigator has ever been inspected by the FDA; whether any of the aforementioned have been issued a 483. Sponsors may also request documentation of the inspection, 483, and any resolution (e.g., corrective and preventative action plan (CAPA)). This guidance is designed to assist investigators in responding to such requests.

FDA Inspection Intake Form

FDA Site Inspection Intake Form

This form helps investigators and research teams through the process when contacted by the FDA for an inspection/audit.

FDA Inspection Intake Form

FDA Site Inspection Guidance

This document provides guidance to investigators and research staff as they navigate the process of FDA inspection.

Contact form icon

IND/IDE Registration

Click below to register a new IND/IDE or a new protocol under an existing IND/IDE.

web link symbol

Links

IND/IDE Consultation Service
The IND/IDE team is the most efficient way for investigators to navigate this important process and minimize unnecessary steps.

 

IND/IDE Resource Library
Explore these curated materials, including IND-related templates, IDE-related templates, FDA resources for drugs, and FDA resources for devices.

 

Health Sciences IRBs Policies on FDA Regulated Research
Policies and guidance documents meant to assist researchers with ensuring compliance with both FDA regulations and institutional requirements.

Questions?

STAFF

Administrative Director

Program Coordinator