Industry-Sponsored Clinical Trial Research Agreements and Payments

Introduction

The University handles industry-sponsored clinical trials differently from other types of sponsored projects for several reasons. The sponsor negotiates the rate they will reimburse the researcher for each participant in the study. This rate is often governed by industry norms rather than actual costs of doing the research. In addition, the actual amount received from the sponsor may vary greatly from the proposed amount because the number of participants enrolled in the study could vary from the original estimate. Therefore, the University handles these types of sponsored projects as follows.

1. Department/PI submits the Proposed Agreement to Sponsored Projects Administration (SPA) through MN-GEMS

   All proposed industry-sponsored clinical trial agreements must be processed through these procedures, regardless of any tentative understanding between the Principal Investigator (PI) and the sponsor. These procedures include fulfilling all compliance requirements, completing a MN-GEMS Funding Proposal, and obtaining required approvals in MN-GEMS. Review by the department head, dean, and administrative personnel is essential to ensuring that the University can provide the space and resources needed to conduct the project. The PI may not enroll patients until the contract is executed and Institutional Review Board (IRB) approval has been obtained.

   SPA recognizes that these types of agreements may need to be approved quickly so the PI may use the following expedited procedures as described in the instructions: MN-GEMS Reference Guide: Industry Funded Clinical Trial Grants & Agreements Guide for the Research Administration Community (google doc)

2. Invoicing and Receiving Sponsor Payments

   The Sponsored Financial Reporting (SFR) accountant will automatically invoice for any non-refundable start-up payment due upon contract execution. In addition, whenever a benchmark has been met, the unit administrator must send a message to [email protected] and then the SFR accountant will book a receivable in EFS and send out an invoice to the sponsor for payment. The message sent to [email protected] must include the following information:

   • EFS (Enterprise Financial System) contract number
   • Sponsor
   • Sponsor award number
   • Principal investigator name
   • Benchmarks that have been met (for example, number of patients who had case report forms submitted)
   • Payment amount owed