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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 Michigan Medicine 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.
If you have further questions, contact a ORSP Clinical Trials Project Representative for information on Clinical Trial Agreements and Medical School Non-Disclosure Agreements.
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.
