Presenters: Beth Nunnally, Corey Graves, Marlys Trettel

Transcription

1 Presenters: Beth Nunnally, Corey Graves, Marlys Trettel 02/17/2014

2 Beth Nunnally, Academic Health Center Associate Vice President & Chief Financial Officer Corey Graves, Research Administrator, Cardiovascular Division Marlys Trettel, Accountant II, CTSI

3 Part I The Past and The Future Beth Part II Clinical Trials (Pre-award) Corey Part III Clinical Trials (Post-award) Marlys

4 Infrastructure Existing systems are disconnected Absence of needed tools Distributed service model Equals = Lack of timely and effective management reports Struggle to manage against deficits Periodic failure to invoice B&I sponsors Lost opportunities to participate in studies due to long startup times

5 Investigator Request Project Development Team Facilitates Concept Protocol Development Approval Processes Trial Implementation Manuscript Budgeting Financial Feasibility Contracting Award Set-Up Clinical Research Billing & Compliance Internal Services Invoicing Award Close-Out These are the necessary components of effective financial management while conducting a clinical trial. Monitoring / Effort / Management Reports Manage A/R Bill / Collect from Sponsors

6 TASCS (Services incurred not yet billed) CTR Portal (Billings in process) EFS (Actual Expenditures, Invoices to Sponsors) Dept Spreadsheets (Accruals) OnCore CTMS (Accruals, Budget, Expenditures, Invoice) IRB E- Protocol Front End Processing Back-End Reporting Data Repository / Data Warehouse Environment(s) AHC Information Exchange (IE) U enterprise level data warehouse(s) AHC-IS regional data warehouse(s)

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9 Close relationship and communication between research, clinical, and administrative (pre- and post-award) staff yields benefits: Efficiencies in administrative processes Timely resolution of common start-up issues Thorough development of cost budgets Accurate budget-to-actual financial reporting Reduced risk of uncollected revenue Reduced risk of erroneous expenditure payments

10 PI voice was heard; HUB conceived on a pilot project basis Integrated service platform Pre-award Financial management and oversight Post-award Scope: B&I-initiated clinical trials for Cardiovascular division, as well as adult oncology (using CTO services) Dedicated team of knowledgeable experts from CTSI, MCC, DOM, SPA, SFR, and Fairview

11 Creating best practice processes and tools for estimating thorough cost budgets Understanding and tracking actual costs in real time Thorough and accurate post-award financial reporting Enhancing service to PIs; engaging PIs during the process so adjustments, if required, are timely Learning financial functionality of OnCore enterprisewide Clinical Trials Management System (CTMS)

12 Inadequate budgeting at core of most financial issues Communication between pre-award, research/clinical staff, and accountants is critical Providing timely and useful management reports for PIs is a very manual and labor-intensive process required effort has generally not been adequately staffed or resourced in the past

13 Convert pilot effort to permanent, effective January 2014 Expansion of scope: a phased approach is being explored with investigators, departments, existing administration

14 Pre-Award

15 PI/Dept + Sponsor = New Study! Proposal Docs Provided Prepare & Submit Proposal Routing Form (PRF) and Proposal Packet (i.e. Expedited PRF, draft CTA and budget, protocol, advance account form) Negotiate & Finalize Budget w/sponsor (obtain pricing from providers Fairview, UMP, etc.) Set up Advance Account Negotiate & Finalize CTA w/sponsor Update Final PRF w/budget info & route for approvals Review and Approve updated PRF PI and SPA (separately): Obtain signatures on CTA Compliance checks (final) Issue NOGA

16 Divide budget into sections Start-up & Close-out Costs Invoiceable Costs Enrollment Costs by visit Budget surplus/deficit Considerations: Inflation Timing of Reimbursement F&A of 26% Negotiation Standardized s

17 Start-up Invoiceables Per-Patient

18 Start-up costs = non-refundable Payment Types Payment for work performed, as-earned is ideal Milestones or other benchmarks are less ideal types Per-subject visit payments based on CRFs submitted (ideal) Pass-through or as-needed items ( Invoiceables ) Payment Triggers CRF Submission (Sponsor/CRO reviews data at set frequency) Data Monitored Payment Frequency/Timing Monthly (ideal) Quarterly Minimize Sponsor holdback on payments NONE is ideal No more than 10%

19 Budget development workbook Include the inflation effect ; costs will almost surely increase over time, while an increase in sponsor payments is rarely negotiated Include costs for tasks that may not be covered by sponsor payments; those costs may still be incurred Use checklists to help ensure a thorough budgeting process Labor hours assumptions: ranges for various tasks performed by research staff Document any assumptions outside of the normal range Templates for communications with sponsors, PIs, department administrators, and research staff

20 Let s make sure we cover our costs for participating in the study! Sponsors initial proposed budgets rarely cover all costs/expenses of studies. It is not uncommon to go back and forth three or four times with the sponsor in the negotiation process.

21 After the NOGA is issued, facilitate a meeting: PI, Pre- Award Contract Administrator, Accountant (Post- Award), Coordinator The purpose of this meeting is to ensure that personnel involved with the clinical trial understand the protocol, visit schedule, and budget as the responsibility is transferred from pre-award to postaward administration

22 Transfer meeting template

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24 Post-Award

25 Review and approve expenses Effort certification Invoice sponsors * Financial reporting * Monitor accounts receivable * Financial close-out * This presentation will focus on these responsibilities

26 Errors on vendor invoices ISO rates Unusual contract terms Large budget-to-actual variances Billing compliance Lag in sponsor payments The list goes on

27 Create a template that lists all invoiceable items specified in the agreement Completion of template (or portions) may need to be done by study coordinator Accountant should SFR information for invoicing when appropriate (quarterly, monthly, etc.) Generally, payments for subject visits are periodically sent by the sponsor and are based on case report forms that have been submitted and reviewed (no invoicing is required)

28 Invoiceables template

29 We want to provide investigators with a current and accurate financial picture of their clinical trial activities Report should include all actual and pending revenue and expenses through a date stated on the report

30 UM Reports show transactions that have been posted to EFS PeopleSoft, but what about amounts that are pending? For a subject visit that occurs today, payment (revenue) from the sponsor may not be received for several months Some/most expenses related to that visit may not be posted to EFS for a month, or two, or three

31 It is difficult for a PI to make financial decisions about a study, unless we can show them: The amount of revenue we expect to receive, and the amount of expenses we expect to pay, as of a certain (and recent) date Funds committed from sources (other than the sponsor) to cover certain expenses or deficits Cash received Receivables outstanding

32 Does not include subject visit payments outstanding (if they are paid via CRF) Fairview P.O. Not an accurate balance

33 # s from TASCS Outstanding Receivables (includes subject visits revenue based on CRFs)

34 Divided into activity types Variance code

35 Accountant should monitor receivable balance (including revenue based on CRFs) If there is a large outstanding receivable balance, the Accountant may have to provide SFR with more detail SFR follows standard procedures to contact the sponsor and collect outstanding balances

36 Excel spreadsheets Multiple uses (i.e. track effort, invoiceables, financial reporting, etc.) UM Reports Transactions posted in EFS TASCS Current University-Fairview-UMP communication interface OnCore Clinical trial management system currently being implemented Functionality includes notification of invoiceable events and milestones CTR Portal System for tracking and invoicing University clinical research services and time Under construction: Financial report (budget vs. actual) Future functionality (currently in concept stage): Budgeting/feasibility tool

37 Hub Tips, Tools, Templates: Budgeting template (Excel) Standard cost assumptions Start-up templates for communication with PI, SPA, sponsor, etc. Agreement terms (ideal, acceptable, unacceptable) Transfer meeting template Invoiceables template Financial report (Excel) Other

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39 Beth Nunnally Terri Thommes Corey Graves Marlys Trettel CTSI Hub address:

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