UW–Madison Investigational New Drug/Investigational Device Exemption (IND/IDE) Registry

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Policy Number:

UW-4084

Responsible Office:

Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy describes the requirement that UW–Madison personnel register their investigator-held investigational new drug (IND) or investigational device exemption (IDE) with the UW–Madison Food and Drug Administration (FDA) Regulated Research Oversight Program.

Policy:

1. The UW–Madison FDA-Regulated Research Oversight Program maintains a registry of all UW–Madison investigator-held INDs/IDEs to ensure institutional compliance with FDA requirements and assist investigators in fulfilling their FDA obligations.
   1. UW–Madison personnel must initiate the IND/IDE registration process with the program no later than the time of submission to the FDA. Further guidance on the UW–Madison IND/IDE registration process is available here.
   2. UW–Madison personnel must also notify the program when an IND/IDE has been closed, terminated, or withdrawn.
2. UW–Madison personnel seeking guidance on the FDA IND/IDE submission process may consult with the ICTR (UW Institute for Clinical and Translational Research) IND/IDE Consultation Service (I3CS).

External References:

ICTR IND/IDE Consultation Service (I3CS)

Policy Administration

Approval Authority:

Associate Vice Chancellor of Research Policy and Compliance

Policy Manager:

Administrative Director FDA Regulated Research Oversight Program

Contact:

Administrative Director FDA Regulated Research Oversight Program -- Jacob Rome, rome2@wisc.edu, (608) 265-3890

Date Issued:

03-14-2018

Revised Dates:

06-09-2020

Retrieved:

12-21-2024 20:29:26