IND/IDE Process: Submit to IRB
For Content and Format of IRB submissions, please see http://research.ucdavis.edu/home.cfm?id=OVC,1,2018 . If after reviewing your submission the IRB still has regulatory concerns, the PI may have to correspond with the FDA to obtain a formal determination of IND exemption or NSR designation.
To file the IDE, go to IDE Step 4
To file the IND, got to IND Step 4