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IND-IDE Assistance Program
The IND/IDE Assistance Program (IAP) is a complimentary education and assistance resource for faculty researchers who are involved in human subject research.
The objective of the IAP is, first, to ensure that all University of Minnesota faculty members who need to file either an IND or IDE do so correctly and in a manner in which it will not detract from their clinical research.
Second, to clarify the complex obligations and responsibilities the FDA has set forth for individuals involved in the filling of an IND/IDE. That is, to give regulatory assistance to the sponsor-investigator of the clinical investigation.
Third, to help faculty researchers be compliant with the University of Minnesota Policy 2.1.10.
This policy states that all University of Minnesota faculty members who file an IND/IDE with the FDA as a sponsor-investigator must submit all documents relevant to the IND/IDE to the central university documentation unit (IND/IDE Assistance Program).
For a comprehensive list of relevant documents to be submitted, see chapter 2.5 for an IND or chapter 3.5 for IDE
Complying with the University policy 2.1.10 is compulsory. To ensure compliance with University policy 2.1.10 the IAP will conduct periodic reviews of your research records.
Contact Us
Harvey M. Arbit, PharmD, MBA
Director IND/IDE Assistance Program
arbit002@umn.edu
phone: 612-625-0930
fax: 612-625-3956
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