| Industry-Sponsored Clinical Trial Contracting |
Industry-sponsored clinical trials fill a key role not only at the U-M Medical School, but with the entire University research enterprise. To streamline the initiation of industry-sponsored clinical trials, the UMMS Office of Research and the Office of Research and Sponsored Projects (ORSP, formerly known as DRDA) have developed a pilot program where several steps in the trial contracting process have been clarified and made more efficient.
A major new component of the pilot program is a Nondisclosure Agreement (NDA) template that can be signed by the school without routing to ORSP for negotiations if the sponsor agrees to the terms. This NDA is intended to expedite the process for exchanging and protecting a sponsor's confidential information prior to entering into a sponsored clinical trial agreement. Often the parties are simply exploring the possibility of a clinical trial that may or may not result in the University and sponsor establishing an agreement. The goal is to provide a fair and balanced NDA that protects the sponsor's information and also meets the needs of the University as a public body.
Open to all industry-sponsored trials at the U-M Medical School, this pilot program is continuing to be evaluated. Below you will find related resources. If you have further questions, please contact the ORSP at 734-764-5500 and ask for a "ORSP Project Representative for Clinical Trial Agreements and Medical School Non-Disclosure Agreements."
Resources
Frequently Asked Questions (FAQ)
U-M Definition of a Clinical Trial
Explanation of the State of Michigan’s Freedom of Information Act
Clinical Trial Contracting Training Powerpoint
Research Project Route Map - Orange Line
Quick Reference Card for Unfunded Agreements (Pilot)
Master Agreements List for Research
Cancer Center Clinical Trials Office
Investigational Drug Service (IDS)
