IND/IDE Sponsor-Investigator Training

Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations

What is this offering?

This is training required as part of your sponsor-investigator responsibilities when you hold an IND or IDE. More information about sponsor-investigator responsibilities can be found in the University of Michigan Human Research Protection Program Operations Manual.
It provides information on the sponsor-investigator requirements of an IND or IDE and resources to assist in order to be in compliance. This training may be provided online, individually in-person or via Zoom, as part of an orientation session, or to a small group or team. Study teams involved in research that uses investigational agents are also welcome to attend this training.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research