Clinical Trials Submitted Successfully – Session #12 Heritage Gallery Presenters: Laura Williams – Sponsored Projects Administration Debra Dykhuis – Office of Clinical Research Bridget Foss – Sponsored Projects Administration. Clinical Trials Trivia Time.
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Laura Williams – Sponsored Projects Administration
Debra Dykhuis – Office of Clinical Research
Bridget Foss – Sponsored Projects Administration
how many open clinical studies underway
in the state of Minnesota?
Laura Williams – Feasibility Considerations
in Clinical Trials
Debra Dykhuis – Budgetary Considerations
in Clinical Trials
Bridget Foss - SPA Submission Processes and Shortcuts
Certainly not to be ignored, but not covered today:
Investigator-sponsored clinical trialsWhat We’ll Cover Today
Laura Williams, Principal Grant and Contract Administrator [email protected]
Estimating Personnel Time and Optimizing Payment Terns
Former Chairman of Rolls Royce
This process allows SPA to negotiate the
Agreement while the department is completing
Expedited PRF Package Includes:
* It is essential that a sponsor contact is included on the PRF for this process to be effective.
Proposals, non-industry funded trials, and
industry funded trials after budget
negotiation require the following:
Is the trial investigator sponsored? industry
Is the project an animal clinical trial or pre-clinical research?
What is the appropriate F&A rate for this particular project?
Industry Funded Clinical Trial: 26% TDC
Non-Industry Funded Clinical Trial: 51% MTDC
Pre-Clinical Research: 51% MTDC
Questions to Consider During PRF Prep
Compliance requirements for Investigators:
SPA also checks the RSPP database for human subjects, animal subjects and/or IBC approvals. Please note that the title used on the PRF needs to match the protocol title approved by RSPP.
Negotiations take time!
Account set up, regardless of funding source, is subject to the terms and conditions of the agreement governing the project. Each project is handled on a case by case basis.