Budget development
CTSI’s Clinical Trials Financial Services (CTFS) pre-award team develops and negotiates budgets with business and industry sponsors.
Business and industry budget preparation
- Complete a Proposal Routing Form (PRF) and request an advanced account
- Communicate with sponsor to acknowledge project and provide timelines and contact information
- Read and understand protocol
- Set-up an initial Excel worksheet with billing designations for service providers
Calendar builds
- Create a study specific calendar of events in OnCore, the University’s enterprise Clinical Trial Management System (CTMS)
- Update calendar based on feedback from the study team and add footnotes to facilitate accurate pricing
Pricing
- Obtain pricing from Fairview Health Services, University of Minnesota Physicians and other service providers
- Develop a study budget including all expected costs
Budget negotiation
- Send sponsor initial offer based on internal budget
- Respond to sponsor inquiries or counter offer with fee justification
- Accept or deny final budget in consultation with PI and study team
Finalizing the clinical trial budget
- Review and route final documents including the Clinical Trial Agreement (CTA) and Proposal Routing Form (PRF) for appropriate signatures
- Set-up revenue tracking in OnCore to support full and accurate revenue recognition
Associated fees and funding for services
CTFS pre-award support, including business and industry budget preparation, calendar builds, or budget negotiation, is provided at no cost to the University of Minnesota investigator, study team, or department. Learn more on CTSI’s website.
Office hours
Contact us to coordinate access to office hours:
- Available during regular business hours
Contact
[email protected]
612-625-4000