This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects require an Investigational New Drug application (IND).
The worksheet is intended as an exercise to help U-M investigators determine whether an IND may be required before initiating a new clinical study. This document can be provided to the IRB in support of an e-Research application prior to initiating an investigator-initiated clinical trial.
Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.