U-M Research & Compliance

Sponsor-Investigator Responsibilities for IND

Download Resource
Topic
Self-Assessement
Type
Form

Investigators who initiate and submit an IND application to the FDA assume the responsibilities of both the investigator and the sponsor. Under FDA regulations, an academic sponsor or sponsor-investigator has the same obligations as a multi-national pharmaceutical manufacturer that sponsors or holds an IND. This form is for Sponsor-Investigators to conduct a self-assessment of their IRB approved studies to ensure that they are meeting their institutional and regulatory requirements.