UW-Madison IND/IDE Registration Policy

Version Date: March 14, 2018

Policy: UW-Madison IND/IDE Registry

Summary: 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 FDA Regulated Research Oversight Program.
1. The UW-Madison FDA Regulated Research Oversight Program (henceforth 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.
1.1. 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 at: [insert hyperlink]
1.2. UW-Madison personnel must also notify the Program when an IND/IDE has been closed, terminated or withdrawn.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 IND/IDE Consultation Service (I3CS). 

Keywords:IND, IDE   Doc ID:85092
Owner:Faye L.Group:Health Sciences IRBs
Created:2018-08-21 15:21 CDTUpdated:2018-09-18 13:44 CDT
Sites:Health Sciences IRBs
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