Sponsored Projects Administration (SPA) is the only University-wide office authorized to enter into grants and contracts with industry sponsors to fund research at the University. SPA’s contracting authority extends to clinical trials agreements, research agreements, and master agreements with for-profit entities.
Getting Started
Clinical Trial Agreement
A Clinical Trial Agreement (CTA) is a legally binding contract that outlines the responsibilities and rights of all parties involved in a clinical trial. A CTA is required for the University’s participation in industry funded clinical trials.
The PI or study team must submit a MN-GEMS funding proposal and agreement record to initiate SPA’s review and negotiation of CTA terms. SPA manages negotiation of the contract terms while the academic department negotiates the budget and payment details with the sponsor. The terms of any negotiated CTA need to align with the University's position as a state institution subject to Minnesota Government Data Practices Act and University’s applicable research policies.
The University of Minnesota is a participating institution to the Accelerated Clinical Trial Agreement (ACTA). The ACTA was developed by industry and academic partners to create a standardized agreement for sponsor-initiated clinical trials with compromise language to accelerate the contracting process. SPA strongly recommends utilizing the ACTA for sponsor initiated clinical trials to reduce the negotiation timelines.
Effective January 2, 2019, industry-sponsored clinical trials should use a rate of at least 30% TDC.
Research Agreement
A Research Agreement (RA) is a legally binding contract that outlines the responsibilities and rights of all parties involved in a research project. An RA is required for the University’s participation in industry funded research.
The PI or study team must submit a MN-GEMS funding proposal and agreement record to initiate SPA’s review and negotiation of RAs. The terms of any negotiated RA need to align with the University’s applicable research policies and processes, including the University’s MN-IP Create program.
Budgets for industry research agreements should reflect the University’s full federally negotiated indirect cost rate. Industry sponsors are NOT automatically eligible for reduced rates based on published company policies or requests for proposals. A reduced rate can only be used on an industry project if an approved waiver is in place. See the University policy and procedures on this topic for more information. An indirect cost reduction will impact negotiation of the research agreement and the terms that the University will offer the sponsor.
Master Agreement
A Master Agreement (MA) is a legally binding contract that defines the terms for a single industry sponsor to fund multiple research or clinical projects over a period of time. While MAs generally take longer to negotiate upfront, MAs help to facilitate collaborative sponsored research and eliminate protracted legal review and negotiation of each new project. In most instances, SPA will require a history of successful single study agreements before it will agree to pursue a MA with an industry sponsor.
Requests for a master research agreement or master clinical trial agreement should be forwarded to your B&I GCO. SPA will work with the sponsor and the Office of General Counsel to put a University-wide master in place. [Please let SPA know immediately if a sponsor has mentioned using a master agreement - not doing so can cause delays for the project in question if all parties are not on the same page.]
See a list of master research agreements at the U of M.
What Happens at SPA After I Submit?
Once the MN-GEMS funding proposal and agreement record have been submitted to SPA, the file is automatically assigned to a Grant and Contract Officer (GCO) within the MN-GEMS system. The agreement is added to the GCO queue for agreement review. Generally, GCOs try to meet a three-week turnaround for initial review. That review time can be impacted by complexity of the arrangement, the condition of the project package, and GCO workload. The GCO will work directly with the sponsor to negotiate terms acceptable to both parties. The GCO will contact the PI and/or administrative contact during negotiation with any project specific questions and will provide the agreement for PI review and signature prior to University endorsement. The status of the proposal or agreement can be viewed through the status and history functions within MN-GEMS.
Requesting an Agreement Template
UMN prefers to contract using its standard agreements.
- Investigator Initiated Clinical Trial Template (OGC-SC744)
- Accelerated Clinical Trial Agreement (OGC-SC740)
- MN-IP Domestic Research Agreement (OGC-SC750)
- Letter of Understanding (OGC-SC752)
If a sponsor requests that you provide an agreement for their consideration, please share the appropriate UMN template available through the UMN Contracts Library. Contact your B&I GCO if you have any questions about which agreement should be used for a particular project or if you would prefer SPA to send the agreement to the sponsor.