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 Clinical Trials Office is available to assist faculty apply for INDs and IDEs. The University has a policy requiring sponsor-investigators to provide copies of all IND/IDE-related documents, including the original submission and all communications with the FDA, to the OVPR.