IND & IDE Management
FDA regulations define a category of researcher called sponsor-investigator. The FDA regulations for both sponsors and for investigators are complex. Sponsor-investigators expose themselves and the institution to a high degree of risk if they failure to comply with research regulations that govern clinical trials. The IND/IDE Assistance Program is available to assist faculty apply for INDs and IDEs. The University has a policy requiring the use of the IND/IDE Documentation Unit to assist with and ascertain compliance with FDA regulations. This policy requires IND and IDE sponsor-investigators to provide copies of all IND/IDE-related documents, including the original submission and all communications with the FDA, to the IND/IDE Documentation Unit.
The policy can be found at the University policy library at http://www.irb.umn.edu/sponsor.html.