FDA Regulated Research Oversight Program

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).

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”.

Click below for instructions on how to access the training.

Policy Summary: This policy outlines requirements for UW–Madison personnel to notify campus officials of IND/IDE submissions, closures, terminations, and other activities.

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

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

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

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.

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.