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Clinical Trials

Clinical Trials

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Clinical Trials

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Presentation Transcript

  1. Clinical Trials

  2. Receiving the NOGA • What is a NOGA? • Notice of Grant Award – an “agreement” between the Sponsor and University of Minnesota • Once the NOGA is received in SFR, the Manager passes it on to the SFR Accountant

  3. Creating the First Invoice • When / how is the first invoice created? • Typically, for Clinical Trials, the NOGA will state if there is: a start up payment, IRB Fee, Pharmacy Fee, Non-Refundable payment etc. • If there is a “start-up” payment, we (SFR) will automatically generate an invoice to send to the Sponsor, as well as send a copy to the Department Accountant and PI

  4. Creating the First Invoice (cont.)

  5. Increasing the Budget • When is the budget increased? • When a payment is received from the Sponsor • When an invoice is requested by the Department/Principal Investigator

  6. Information Needed When Requesting an Invoice • When an invoice is needed, requests can be sent directly to Leah MacKenzie via email • What information should be included? • Project # / Contract # • Description of what is being invoiced (i.e. patient vists, travel, hotel, IRB Renewal, etc.) • Dollar amount(s) to invoice • Pertinent back-up documentation to be sent along with the invoice

  7. What is “proper” back-up? • IRB Fees • IRB approval letter / email • Patient Visits • Document showing patient #’s, visit #, amounts, visit date, etc. • Travel • MapQuest’s, Hotel/Food/Airfare Receipts • Advertisement • Invoices from advertisement agencies

  8. Why is my Invoice Unpaid? • Most commonly, an invoice is unpaid because the Sponsor is requesting further back-up documentation to support the invoice. In these cases, we will contact the Department/PI to provide such documentation. • The Sponsor needs the PI’s report. A lot of times, the final payment will not be paid until the Sponsor has received all the proper reports from the PI and they will withhold payment until such reports are received.

  9. When is an Award Considered “Ready for Closeouts” • A Clinical Trial award is ready to be sent to “close-outs” when: • All work on the project has been completed • All reports (if applicable) have been sent to the Sponsor • No more money or invoicing on the award is expected

  10. When Does an Award Need a No Cost Extension? • A No Cost Extension is needed when: • The award end date has lapsed and work is not yet complete • If the NOGA states that there is no firm end date, an extension can usually be requested through your Grant Administrator (GA) in SPA – they will need the “okay” from the PI, along with an estimated end date • If the NOGA states there is a firm end date, the GA will work with the Sponsor, PI & Department to negotiate a new end date

  11. Questions?

  12. Contact Information • Leah MacKenzie • 612-624-6829 • mummx015@umn.edu • Kerry Marsolek • 612-624-8053 • kerry@umn.edu