FDA Regulated Research Oversight Program

The FDA Regulated Research Oversight Program, a partnership between the UW Clinical Trials Institute, 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).

VIEW THE POLICY

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”.

VIEW THE POLICY

Click below for instructions on how to access the training.

REGISTRATION

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.

VIEW THE POLICY

Conduct of Routine Internal Reviews

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

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Guidance Documents

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 Site Inspection Guidance

FDA Site Inspection Guidance

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

Form FDA 1572 Guidance

UW Procedures for Listing Sub-Investigators on Form 1572

Research teams and sponsors can vary considerably in who they consider to be Sub-Investigators for purposes of completing Food and Drug Administration Form FDA 1572, Statement of the Investigator (1572). Sponsors may also request inclusion of specific research team members on the 1572, which deviates from local practice. Given this variability, the need for consistency, and the significant obligations associated with being listed as a Sub-Investigator, this guidance was established to support research teams in identifying only the necessary individuals to include as sub-investigators on Form 1572.

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.

IND/IDE Registration

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

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 (In process)
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?

Email

608.265.3132

STAFF

JACOB ROME

Administrative Director