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Business & Industry Contracts

Procedure for Allowable B&I Clinical Trial Start-Up Costs

Business and Industry (B&I)-sponsored clinical trials that have start-up costs incurred prior to the effective date of the agreement should follow this procedure when the project accountant or research coordinator notifies SPA that they are unable to process project expenses because the account date does not include the date of service for the expense.

If Start-up Costs are Included in the Approved Budget

If the sponsor-approved clinical trial agreement budget reflects planned start-up costs that will be incurred prior to the effective date of the agreement, Sponsored Projects Administration (SPA) will generate a revised NOGA. The NOGA will retain the project start and end dates as detailed in the agreement, but SPA will add a clarification comment to the NOGA (e.g., “This revised NOGA recognizes allowable budgeted startup costs incurred between ______ [date of first pre-award expense] and the Effective Date of the clinical trial agreement.”). SPA will then change the dates to reflect the date of first pre-award expense, and a note of “start-up date” will be added to the comments field.

If Start-up Costs are Not Included in the Approved Budget

If start-up expenses are incurred but were not included in the sponsor-approved final budget, the principal investigator (PI) will be required to send a letter or e-mail to certify that the costs were reasonable, allocable, and directly related to start-up activities for the clinical trial. The PI is then required to get the approval of their department head, or their dean if the PI is the department head. A revised NOGA will then be generated by SPA. The NOGA will have the project start and end dates as detailed in the agreement, but SPA will add a clarification comment to the NOGA (e.g., “This revised NOGA recognizes allowable but non-budgeted start-up costs incurred between ______ [date of first pre-award expense] and the Effective Date of the clinical trial agreement. The PI has certified these costs as reasonable, allocable, and directly related to start-up activities for the project.”). SPA will then change the dates to reflect the date of first preaward expense, and a note of “start-up date” will be added to the comments field.

Master Agreements

Master Research Agreements

A master research agreement (MRA) defines the terms for a single industry sponsor (company) to fund multiple research projects over a period of time. MRAs help to facilitate collaborative sponsored research and eliminate protracted legal review and negotiation of each new project.

Most MRAs are based on the Minnesota Innovation Partnerships (MN-IP) program, which provides a range of options that reduce the risk and cost associated with licensing intellectual property and sponsoring research and make it easier for companies to partner with the U of M.

See a list of master research agreements at the U of M.

Master Clinical Trial Agreements

A master clinical trial agreement is a type of master research agreement that is specific to clinical trials.

Sample Agreements