Faculty want to submit an Investigator-initiated Investigational IND to FDA, as a part of an FDA-funded grant. Do they need to get the Electronic Submissions Gateway (ESG) account, or does SPA already have it?
Thank you for your inquiry. Investigator-initiated IND’s are handled by the Human Resource Protection office, please contact HRPO regarding the Electronic Submissions Gateway. A key contact person for that office is as follows:
Human Protections Administrator – Julie Doherty, RN, MSN
Title: Director, Human Protections Administrator and Research Subject Advocate
Location: Lexington Building, 2nd Floor