Michigan Institute for Clinical and Health Research (MICHR) IND/IDE Resources

Overview

If you are working with or planning to work with an investigational agent in human research the MICHR IND/IDE Investigator Assistance Program (MIAP) Program offers services to help you through the process. Specifically these services are geared toward investigators who will also serve as the sponsor for their project.

It is recommended that you contact MIAP early on in the process as soon as you have an idea that may, at some point, involve a clinical trial utilizing an FDA-regulated drug or a device. 


Links

IND/IDE Sponsor-Investigator Training
This is a training required by Office of Human Research Compliance Review (OHRCR) for all U-M faculty who will hold an IND or IDE and are thus considered a sponsor-investigator. It provides information on the sponsor-investigator requirements of an IND or IDE and resources to assist in order to be in compliance.

IND/IDE Lifecycle Maintenance
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required by an active IND or IDE.

IND/IDE Application Preparation & Submission
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support and expertise to prepare and submit Investigational New Drug and Investigational Device Exemption applications to the FDA, required for the use of investigational drugs and devices in clinical research.

IND/IDE Consultation & Development
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides consultation on research involving investigational agents (drugs, devices, and biologics).


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the MICHR MIAP Program.

Was this article helpful?

Can’t find what you’re looking for?

Subscribe to Breakthrough, MICHR’s monthly e-newsletter