Confused about the need to file an IND? Think your study may be exempt? Not sure where to start? You are not alone.
Please review the guidance offered by the UCSF IRB HRPP and the Office of Ethics and Compliance (OEC).
Still have questions? Contact the UCSF FDA Regulatory Support Team at [email protected] or complete their form. The final decision regarding whether you are required to obtain an IND may be made only by the FDA or an IRB.