Investigational New Drug or Device Exemption

Sponsorship of an Investigational New Drug (“IND”) or an Investigational Device Exemption ("IDE") application by UA or UA personnel may create an Institutional Conflict of Interest. Accordingly, all IND/IDE applications must be reviewed and approved by the Executive Review Committee (“ERC”) prior to any clinical work being performed. As Principal Investigator of the IND/IDE, please submit an IND/IDE Worksheet to the Office for Responsible Outside Interests via eDisclosure as far in advance of your anticipated IND/IDE clinical start date as possible, to minimize the risk of delays while awaiting ERC review.  Please see the IND Flowchart or IDE Flowchart for more information about the IND and IDE processes.