IND/IDE determination and support

CTSI's Regulatory Support function, in collaboration with the University of Minnesota's Human Research Protection Program (HRPP) IND/IDE function, assist investigators initiating a study that involves an investigational agent in human research participants with the determination and necessary attainment of an investigational new drug (IND) or investigational device exemption (IDE) from the Food and Drug Administration (FDA). 

Determination assistance

  • Assistance determining whether a protocol requires an IND or IDE

Application assistance

  • Assistance assembling the FDA application for an IND or IDE and submission of the application

FDA meeting support

  • Preparation and support for FDA meeting requests

Regulation guidance

  • Expert guidance navigating the regulations

Associated fees and funding for services

There are no fees for the investigator, study team, or department for IND/IDE determination and application support. 

Office hours

Contact us to coordinate access to office hours:

  • HRPP IND/IDE: By appointment only
  • CTSI IND/IDE Assistance Program: Available during regular business hours


[email protected]