Study teams who are planning on submitting a single patient IND or IDE should follow the directions in the guidance documents below. The protocol must be received by OHRS 48 hours in advance of IRB review in order to ensure sufficient time for review of the protocol.

• OHRS Info Sheet on Single Patient INDs and Emergency Use of a Test Article

• Single Patient IND Alert Page Template

• Link to FDA Guidance on "Physician Request for a Single Patient IND for Compassionate or Emergency Use" located at: http://www.fda.gov/cder/cancer/singleIND.htm