Clinical Trials is a type of "Other Sponsored Activity."
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 clinical trials, the UMMS Office of Research and the Office of Research and Sponsored Projects (ORSP) have developed a program where several steps in the trial contracting process have been clarified and made more efficient.
A major component of the 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.
Another important component of the program is the use of the Clinical Trial Routing Form (CTRF) which allows study teams to send draft agreements for the trial to ORSP for contract terms review prior to the routing of a PAF with final financial arrangements. Further information on the CTRF is available.
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."