IND/IDE Decision Guidance and Worksheet


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.


FDA Guidance - Determining whether human research studies need an IND.pdf

IND Decision Worksheet.pdf

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