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 services available from the IND/IDE Assistance program include:
- Explanation of IND and IDE regulations
- Assistance in understanding the obligations of a sponsor-investigator
- Assistance in determining product classification, i.e., drug, device, biologic
- Assistance in determining applicability of an IND or IDE
- Assistance in determining contents of IND or IDE
- Assistance in submitting IND and IDE applications to FDA
- Assistance in scheduling, coordinating, preparing and attending meetings with FDA
- Regulatory support for IRB applications
- Regulatory assistance during FDA inspections of investigator sponsored clinical trials
- Periodic news items from FDA relating to sponsor-investigator clinical trials
The policy can be found at the University policy library at http://www.irb.umn.edu/sponsor.html.