Financial Management of Clinical Trials - Sponsored Projects ...

Kamala Upadhyaya, Senior Finance Manager, Sponsored Financial Reporting
Debbie Dykhuis, Research Project Manager, Clinical and Translational Science Institute
02.14.2012

“What we’ve got here is (a) failure to communicate.”
• The Captain (Strother Martin) - Cool Hand Luke (1967)

The study team (investigator, coordinator, other staff)
Center accounting staff
Sponsored Projects Administration (SPA)
Sponsored Financial Reporting (SFR)

Study team Dept/Center/Cluster SPA SFR
Pre-award
Feasibility
Budget prep
Budget negotiation
TASCS setup
Set payment terms
Review & approve
Review & approve
Negotiate contract
language
PRF prep Review & approve Set up account
Setup Fairview Acct Approve PO Prepare NOGA
Enroll subjects/complete
Subject Tracking Form
Initiation meeting
Invoice sponsor for
startup $
Track occurrence of
invoiceables/report to
dept
Request invoice from
SFR/ track receipt of
payment
Invoice sponsors
Post-award
Monitor dollars received
for work performed
Prepare reports to PI on
account status
Collect payments from
sponsors
Notify dept/SPA of
agreement changes
Notify dept at study end,
close with IDS, IRB, FV
Charge effort based on
budgeted time per visit
Process/pay vendor
invoices
Complete fixed price
closeout form or clear
deficit
Handle contract
amendments
Move funds/ zero out
account

◦ Feasibility Assessment (identification of
services/prices, TASCS, estimating personnel time)
– study team
◦ Budget preparation and negotiation – study team
◦ Payment terms review and negotiation – study
team and center
◦ Proposal Routing Form preparation – study team
◦ Proposal Routing Form review & approval – center
◦ Negotiate Clinical Trial Agreement language – SPA
◦ Prepare Notice of Grant Award (NOGA) - SPA

This is the time for the study team and center
accountant to start a conversation that will last
through the close-out process.
Opportunity to review any “invoiceable” items
proposed in the budget and to develop a plan for
communicating when these items or services occur.
“Invoiceables” Happen – if you don’t have a plan for
communicating when “invoiceables” happen it is the
same as agreeing to do these things for free!

Review payment terms carefully – and consider the
following:
◦ Make sure that payments for start-up costs are nonrefundable
◦ Do not accept payment terms tied to achieving enrollment
goals – or that otherwise might require the University to
carry unreimbursed expenses indefinitely. Ask, instead, for
payments on a quarterly basis (for work performed as
defined in the budget).
◦ Try to minimize the sponsor holdback on payments (should
not be more than 10%)

◦ Enroll research subjects and complete Subject Tracking Form in
TASCS – study team
◦ Track and communicate information about “invoiceable” items –
study team to center accountant
◦ Collect and communicate information about any changes in the
agreement/contract – study team to center accountant
◦ Monitor dollars received for work performed – study team and
center accountant
◦ Prepare reports on account for investigator and charge effort based
on budgeted dollars – center accountant
◦ Review and approve vendor charges – center accountant and study
team
◦ Process/pay vendor invoices – center/cluster accountant

Budgeted Effort
Medical Services Used
Subject Tracking Form
Reports available to all TASCS users. Reports Only instance is
also available – no training required. Contact tascs@umn.edu
for an “Access Request Form”.

Negotiates and signs the Clinical Trial Agreements
Reviews payment terms
Gets clarification of non-refundable amount and reversion
of funds
Reviews the language about
◦ Intellectual Property
◦ Publication Restrictions
◦ Termination clause

Checks for regulatory compliance like the IRB approval. If
the approval is pending, then SPA will note it on the NOGA
under Special Review section that costs related to subject
payment cannot be charged on the project till IRB approval
is obtained
Generates the Notice of Grant Award and emails it to the PI
and SFR
Sets up the budget for the initial payment
Works with SFR to send the invoice for the initial start up
payment

Responsible for invoicing to the sponsor for “Invoiceables”
such as:
◦ IRB fees
◦ Pharmacy renewal fees
◦ Protocol amendment processing fees, etc.
Departmental staff - study team or center accountant
should email SFR with the pertinent back-up
documentation for invoicing when certain benchmarks are
met.
Generally, payments for subject visits are made by the
sponsor upon receipt and review of case report forms.

Will create an internal invoice to apply payments
Will increase the budget whenever they create an invoice
Responsible for follow-up and collection of the invoice.
Responsible for financial system close of the project

Kamala Upadhyaya – upadh004@umn.edu
612-624-2014
Debbie Dykhuis – dykhu001@umn.edu
612-625-9154

©2009 Regents of the University of Minnesota. All rights reserved. The University of Minnesota is an equal opportunity educator and employer.
This presentation is available in alternative formats upon request. Direct requests to genox003@umn.edu or 612.624.5599.