Financial Management of Clinical Trials - Sponsored Projects ...
Financial Management of Clinical Trials - Sponsored Projects ...
Financial Management of Clinical Trials - Sponsored Projects ...
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Kamala Upadhyaya, Senior Finance Manager, <strong>Sponsored</strong> <strong>Financial</strong> Reporting<br />
Debbie Dykhuis, Research Project Manager, <strong>Clinical</strong> and Translational Science Institute<br />
02.14.2012
“What we’ve got here is (a) failure to communicate.”<br />
• The Captain (Strother Martin) - Cool Hand Luke (1967)
The study team (investigator, coordinator, other staff)<br />
Center accounting staff<br />
<strong>Sponsored</strong> <strong>Projects</strong> Administration (SPA)<br />
<strong>Sponsored</strong> <strong>Financial</strong> Reporting (SFR)
Study team Dept/Center/Cluster SPA SFR<br />
Pre-award<br />
Feasibility<br />
Budget prep<br />
Budget negotiation<br />
TASCS setup<br />
Set payment terms<br />
Review & approve<br />
Review & approve<br />
Negotiate contract<br />
language<br />
PRF prep Review & approve Set up account<br />
Setup Fairview Acct Approve PO Prepare NOGA<br />
Enroll subjects/complete<br />
Subject Tracking Form<br />
Initiation meeting<br />
Invoice sponsor for<br />
startup $<br />
Track occurrence <strong>of</strong><br />
invoiceables/report to<br />
dept<br />
Request invoice from<br />
SFR/ track receipt <strong>of</strong><br />
payment<br />
Invoice sponsors<br />
Post-award<br />
Monitor dollars received<br />
for work performed<br />
Prepare reports to PI on<br />
account status<br />
Collect payments from<br />
sponsors<br />
Notify dept/SPA <strong>of</strong><br />
agreement changes<br />
Notify dept at study end,<br />
close with IDS, IRB, FV<br />
Charge effort based on<br />
budgeted time per visit<br />
Process/pay vendor<br />
invoices<br />
Complete fixed price<br />
closeout form or clear<br />
deficit<br />
Handle contract<br />
amendments<br />
Move funds/ zero out<br />
account
◦ Feasibility Assessment (identification <strong>of</strong><br />
services/prices, TASCS, estimating personnel time)<br />
– study team<br />
◦ Budget preparation and negotiation – study team<br />
◦ Payment terms review and negotiation – study<br />
team and center<br />
◦ Proposal Routing Form preparation – study team<br />
◦ Proposal Routing Form review & approval – center<br />
◦ Negotiate <strong>Clinical</strong> Trial Agreement language – SPA<br />
◦ Prepare Notice <strong>of</strong> Grant Award (NOGA) - SPA
This is the time for the study team and center<br />
accountant to start a conversation that will last<br />
through the close-out process.<br />
Opportunity to review any “invoiceable” items<br />
proposed in the budget and to develop a plan for<br />
communicating when these items or services occur.<br />
“Invoiceables” Happen – if you don’t have a plan for<br />
communicating when “invoiceables” happen it is the<br />
same as agreeing to do these things for free!
Review payment terms carefully – and consider the<br />
following:<br />
◦ Make sure that payments for start-up costs are nonrefundable<br />
◦ Do not accept payment terms tied to achieving enrollment<br />
goals – or that otherwise might require the University to<br />
carry unreimbursed expenses indefinitely. Ask, instead, for<br />
payments on a quarterly basis (for work performed as<br />
defined in the budget).<br />
◦ Try to minimize the sponsor holdback on payments (should<br />
not be more than 10%)
◦ Enroll research subjects and complete Subject Tracking Form in<br />
TASCS – study team<br />
◦ Track and communicate information about “invoiceable” items –<br />
study team to center accountant<br />
◦ Collect and communicate information about any changes in the<br />
agreement/contract – study team to center accountant<br />
◦ Monitor dollars received for work performed – study team and<br />
center accountant<br />
◦ Prepare reports on account for investigator and charge effort based<br />
on budgeted dollars – center accountant<br />
◦ Review and approve vendor charges – center accountant and study<br />
team<br />
◦ Process/pay vendor invoices – center/cluster accountant
Budgeted Effort<br />
Medical Services Used<br />
Subject Tracking Form<br />
Reports available to all TASCS users. Reports Only instance is<br />
also available – no training required. Contact tascs@umn.edu<br />
for an “Access Request Form”.
Negotiates and signs the <strong>Clinical</strong> Trial Agreements<br />
Reviews payment terms<br />
Gets clarification <strong>of</strong> non-refundable amount and reversion<br />
<strong>of</strong> funds<br />
Reviews the language about<br />
◦ Intellectual Property<br />
◦ Publication Restrictions<br />
◦ Termination clause
Checks for regulatory compliance like the IRB approval. If<br />
the approval is pending, then SPA will note it on the NOGA<br />
under Special Review section that costs related to subject<br />
payment cannot be charged on the project till IRB approval<br />
is obtained<br />
Generates the Notice <strong>of</strong> Grant Award and emails it to the PI<br />
and SFR<br />
Sets up the budget for the initial payment<br />
Works with SFR to send the invoice for the initial start up<br />
payment
Responsible for invoicing to the sponsor for “Invoiceables”<br />
such as:<br />
◦ IRB fees<br />
◦ Pharmacy renewal fees<br />
◦ Protocol amendment processing fees, etc.<br />
Departmental staff - study team or center accountant<br />
should email SFR with the pertinent back-up<br />
documentation for invoicing when certain benchmarks are<br />
met.<br />
Generally, payments for subject visits are made by the<br />
sponsor upon receipt and review <strong>of</strong> case report forms.
Will create an internal invoice to apply payments<br />
Will increase the budget whenever they create an invoice<br />
Responsible for follow-up and collection <strong>of</strong> the invoice.<br />
Responsible for financial system close <strong>of</strong> the project
Kamala Upadhyaya – upadh004@umn.edu<br />
612-624-2014<br />
Debbie Dykhuis – dykhu001@umn.edu<br />
612-625-9154
©2009 Regents <strong>of</strong> the University <strong>of</strong> Minnesota. All rights reserved. The University <strong>of</strong> Minnesota is an equal opportunity educator and employer.<br />
This presentation is available in alternative formats upon request. Direct requests to genox003@umn.edu or 612.624.5599.