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IND-IDE Assistance Program


The IND/IDE Assistance Program (IAP) is an education and assistance resource for faculty researchers regarding Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.

 

 

IAP Objectives:

 

  

·         To ensure that all University of Cincinnati faculty members who need to file either an IND or IDE (see DEFINITIONS) do so correctly and in a manner in which it will not detract from their clinical research.

·         To provide regulatory assistance to the Sponsor-Investigator (see DEFINITIONS) of the clinical investigation.

·         To help faculty researchers be in compliance with the University of Cincinnati Policies (see POLICIES).  

 

 

Policy III.08 states that all University of Cincinnati faculty members who file an IND/IDE with the FDA as a sponsor-investigator must submit all relevant documents to the FDA Specialist out of the IAP. For a comprehensive list of relevant documents to be submitted, see FORMS tab. To ensure compliance with the University and the FDA, the IND/IDE Assistance Program will conduct periodic reviews of your research records.

 

 

 

Contact Us

Angela Braggs-Brown

Interim Director

IND/IDE Assistance Program

broag@ucmail.uc.edu

phone: 513-558-3005

fax: 513-558-3539