Single Patient IND/Emergency Use of a Test Article
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. Please note that the individual submitting the high priority protocol must be available for contact up to one business day post-submission.
Upon submission, please inform OHRS of the high priority protocol by emailing the DFCI OHRS High Priority group at firstname.lastname@example.org.