Industry (G000770) Clinical Trial Pre-Closeout Checklist

1. Industry (G000770) Clinical Trial Pre-Closeout Checklist Informal Presentation to COM 11/10/08 Edy Zettler C&G Research Administrator II Industry and Foundations Team Lead ezettler@ufl.edu

2. Things to Know Before You Start • Know the Project #, Contract #, Chartfield String and KK Level for the project. • Project # • From NOA • Grants<Awards<Award Summary Page • From NOA • Grants<Awards<Project Summary Page • Chartfield String (Department, Fund, Program, Source of Funds) • From NOA • Grants<Awards<Project Summary Page • Grants<Awards<Project Budget • KK Budget Level • From NOA • Grants<Awards<Project Summary Page

3. Things to Know Before You Start continued • Who is Principal Investigator (PI)? • Who is UF Study Coordinator? • Who sends the Case Report Forms (CRFs) or invoices? • Who does the payroll distributions? • Who is the correct C&G Research Administrator (RA) contact? • Go to http://fa.ufl.edu/cg/. • Open excel spreadsheet “Original Fund Source Agency Contacts”. • Find SOF code & then look up name.

4. Main C&G Industry (G000770) Contacts (as of 11/10/08) • Industry NON-Clinical Trials • All Departments Becky Hyde – blhyde@ufl.edu • Industry Clinical Trials • Departments 00000000-29149999 Erin Whitten – erexvb@ufl.edu • Departments 29150000-57999999 Carlene Reddick – reddickc@ufl.edu

5. Things to Complete Before You Start • All CRFs/invoices have been sent. • All payments have been received. • IRB/IACUCS are closed. • Any Research and Compliance (Clinical Trial Compliance) issues have been resolved.

6. Wise Words from CTC Office • Clinical Trial Closure • Upon completion of the study, compare the approved budget with the actual project expenditures. Ensure all services were billed and paid appropriately. • Once all services have been completed, email the finalized tracking log with study related services to the Research and Compliance Office at CTC-AUDITORS@ufl.edu. • All billing errors must be corrected before closing the clinical trial with Contracts and Grants.  • If you have any questions regarding clinical trials billing compliance, please feel free to contact the RAC office for assistance at (352) 273-5946.

7. Things to Have Before You Start • NOA • Obtain copy of the NOAs - (or at least the first & last NOAs) • IRB/IACUC Study Closure Report • Contact the UF Study Coordinator (or whomever closes the IRB/IACUC) to ensure IRBs and/or IACUCs are closed • Ask for a copy of the page of the Study Closure Report that shows how many subjects were seen • Pre-Closeout Checklist • Ask your C&G contact for a copy

8. Pre-Close Checklist • Once the Study Coordinator or PI lets you know that a project is ready for the fiscal closeout, you will need to go through the Pre-Close Checklist before you request the close from C&G. • Checklist is available from your C&G Industry Team contact.

9. “__ Check to see if Project has previously been closed…” • How do I know if the project has been closed before? Hints may include: • Department has a copy of an older Close Memo; • Project is already listed on the closeout waiting list; • Go to http://fa.ufl.edu/cg/. • Open Excel spreadsheet “Industry G000770 Closeout Status” . • Edit<Find – Enter project #. • If already on list, research the current status. • Spreadsheet updated weekly. • KK Balance is $0.00; • Ledgers show there is a previous residual transfer under account code 811000; • Grants<Awards<Project“Project General” tabhas a “Status” of “Inactive”; • Your C&G contact tells you it was….

10. “__Check in PS. Are there any subprojects related to this closeout?” • How do I find related Projects? • Grants<Awards<Award Summary Page (need contract #) • All sub projects must be closed before the master (Primary Project) can be closed. • If your PI holds the Primary Project, he/she (you) are responsible for making sure that the PI and department with a subproject has completed all requirements.

11. “__Check contract for Final Reports, Residual Returns, Revenue Refunds, or pending invoices due to agency.” • How do I know if all reports, invoices, refunds have been done? • Read written agreement behind firstNOA to determine if there are any final reports or residual returns due. • Check with UF Study Coordinator. He/she needs to confirm that: • All Case Report Forms have been sent; • All payments sent match CRF/IRB/Invoice data; • The Sponsor sent all payments due to UF. Note: The IRB Study Closure Report can help determine if all subjects were paid for. • Check with PI.

12. “__Review Budgets Overview - There must be NO encumbrances, pre-encumbrances, or overspending.” • How do I review Budgets Overview? • Must haveBudgets Overview inquiry run control set up (Instructions available on the web at www.hr.ufl.edu/training/myufl/toolkits). • Commitment Control<Review Budget Activities<Budgets Overview – Select your Inquiry Name and enter project #. • There should be no encumbrances, pre-encumbrances, or negative balances. If there are, these must be corrected before requesting a closeout.

13. “__Confirm that IDC budget is right via Budgets Overview…” • How do I confirm IDC budget? • You must know the F&A Base ID and F&A Rate % for this project: • See NOA or • Grants<Awards<Project Summary Page. • IF F&A Base ID is “TDC”, review Budgets Overview & NOA to calculate correct Direct /Indirect Budgets: • Direct = Total Award Amount / 1.xx, where “xx” is the F&A rate • Indirect = Total Award Amount – Direct • e.g. for an award that is $453,353.67: • Direct = $453,353.67/1.25 = $362,682.94 • Indirect = $453,353.67 - $362,682.94 = $90,670.73 • IF F&A Base ID is “MTDC”, you must exclude exemptions. Ask for help from your C&G contact if you are not sure how to do this.

14. “__ …acquire a payment history summary from sponsor…” • How do I get a payment history summary? • Ask your UF Study Coordinator to provide you with a Payment History Summary from the Sponsor. • Contact Sponsor’s Accounts Payable Department or Sponsor’s Case Manager for the project. • Some Sponsors have websites. • Some Sponsors send these with each payment. • Remember – The UF Study Coordinator needs to confirm that the payments sent match CRF/IRB/Invoice data and that Sponsor sent all payments due to UF. • The IRB Study Closure Report can help determine if all subjects were paid for.

15. “__Perform payment audit…” • How do I perform a payment audit? • Manually compare the checks included in the NOAs to see if they match the checks listed on the Payment History Summary. • Make sure “pass-through” expenditures have been accounted for correctly. • Eg: If Sponsor paid WIRB fees directly, they may list as payment, but UF would not have received this check. • If payments are missing or do not match you will need to research why.

16. What if Award Amount Does Not Equal Payments in Summary? • Is a check missing? • Does it show up in C&G deposit log? • Go to http://fa.ufl.edu/cg/. • Open excel spreadsheet Deposit Log. • Search for check using check number, agency name or amount. Note Project #. • If not in log, contact Sponsor Accounts Payable department to trace check. • If in log, was it put into a different project or holding account? Ask your C&G contact to help. • If sponsor did not pay all that was owed, Study Coordinator or PI will need to contact sponsor.

17. How to Run Queries • To run a Peoplesoft Public Query: • PeopleSoft Financials PeopleTools • Choose Financials PeopleTools • Navigate to Query Viewer • Search by Query Name and enter your query name in “begins with” field. It is possible to search by entering a portion of Query Name. • Choose report format by clicking on HTML or Excel links. • Click on View Results to view report.

18. Where are the Queries? • PeopleSoft<Financials People Tools<Reporting Tools<Query<Query Viewer • Public Queries • UF_AR_ACTIVITY_BY_CONTRACT • UF_GM_FINAL_CLOSE_OUT_QUERY • UF_GM_PROJ_RES_RECON_FINAL • UF_GM_PC_GL_KK_COMPARISON (aka “Triple Query”)

19. “__Run AR_ACTIVITY_BY_CONTRACT query to determine if all payments have been applied to project. If not, contact C&G.” • Use to find out if payments have been received and applied to your project. • Will prompt for Contract #. • Sort by “AR Type”. • Subtotal by “AR Type” • “Invoice Total” should equal total of award on last NOA. • “Applied Total” is total of payments applied, and should equal total of payment history summary. • Grand Total should equal “$0.00”.

20. “__Run UF_GM_PC_GL_KK_COMPARISON query (“Triple Query”) to ensure that all three ledgers match.” • Three UF ledgers – • KK- Commitment Control (tracks budget) • GL-General Ledger (UF’s official accounting record) • PC- Project Costing in Project Resource (billing, calculates F&A, stores data related to project) • AKA “Triple Query”: • Compares current amounts posted to each of the three ledgers. • Will prompt for project number. • Sort by “PC”. • Subtotal by “PC” “Sum” “Sum Amount”. • Highlight or bold the totals. • All three must match at closeout.

21. “__Run UF_GM_FINAL_CLOSE_OUT_QUERY…” • This query will show if there is any Petty Cash, Travel Advances, or Expense Advances still pending on the project. • Query must be blank. • If items appear, you must remove them from the project.

22. “__Run UF_GM_PROJ_RES_RECON_FINAL query…” • Gives details of Project Resource Ledger. • Use to get Voucher #s for problem items. • Will prompt for project # and Acctg Date. • Use “t” as Acctg Date to get all current. • Sort by “Account” then by “Acctg Date”. • Subtotal by “Account” “Sum” “Amount”.

23. Are the Chartfields Correct for Each Item? • Use Project Resource Ledger. • Look for errors in SOF & Program Codes. • Look for incorrect/unallowed Account Codes. • E2E errors (can be corrected in bulk by account code).

24. “__Check ledger for unallowable items…”and “___If level 5, check ledger…” • How do I determine allowed/unallowed costs? • UF Policy (Compliance Monitoring) http://fa.ufl.edu/uco/handbook/handbook.asp?doc=1.4.5.6 • UF Policy (Controller’s Office) http://fa.ufl.edu/uco/handbook/handbook.asp?doc=1.4.13.3 • UF Policy (DSR) http://research.ufl.edu/research/handbook/researcher_handbook.html • UF Policy (Clinical Trials Compliance) http://ctc.health.ufl.edu/ • Always look at written agreement (usually behind the first NOA). • LEVEL 5 projects must follow sponsor budget! Any deviations must have written permission.

25. AllowabilityPer UF Policy (Compliance Monitoring) • The following criteria must be used in determining the allowability of costs charged or allocated to grant or contract accounts: • Reasonableness of costs - to determine reasonableness of a cost, consideration is given to: • Whether the cost is ordinary and necessary to the performance of the contract or grant; • Restraints or requirements imposed by factors such as sound business practice, arms-length bargaining, federal and state laws, and regulations and contract and grant conditions; • The action that a prudent person would take in the circumstances; and • The consistent treatment of costs as per established institutional policy. • Allocability of costs - A cost is allocable if it: • Is incurred specifically for the contract or grant; • Benefits the contract or grant being charged; • Is necessary to the overall operation of the project. • Prior approval - Prior institutional or awarding agency approval has been obtained where required.

26. AllowabilityPer UF Policy (Controller’s Office) • Contract & Grant funds: • Sponsored Projects/Contracts and Grant moneys are generally more restrictive in that expenditures must generally meet specific budgetary requirements of the project. • However, such projects may also specify payments that would otherwise not be allowed, such as payments to research participants and certain items of a personal nature that are necessary as part of the sponsored project, such as food or clothing items. • Funds 201 (Federal) and 209 (Non-Federal) shall not be used for entertainment and food expenses unless specifically allowed by the sponsor of said contract or grant. • For these funds, the University will continue to use the expenditure guidelines for appropriations set forth by the State Department of Financial Services, Division of Accounting and Auditing. • Funds 211 (Returned Overhead), 212 (Residual Balances) and 213 (UFRF Allocations) are discretionary moneys restricted for purposes of supporting research.

27. AllowabilityPer UF Policy (DSR) • Non-Federal Sponsored Agreements: • All costs may be direct charged to a non-federal sponsored agreement as long as they have been approved by the awarding sponsor. All questions should be directed to the appropriate contract and grant office for your college.

28. AllowabilityPer UF Policy (CTC) • Caution needs to be emphasized regarding spending any clinical trial funds for other purposes before the closure of the trial.  • It is not advisable to charge any non-trial services to the clinical trial account such as investigator education that is not directly related to that trial during the trial. • If Standard of Care (SOC) services were billed to 3rd party payors, it is important to be sure that the Sponsor didn’t provide money for those services. • If the study was a cost reimbursement trial and all charges have been settled per the contract agreement, you may move any allowable residual balance to a miscellaneous donors account for future research related activities such as professional travel. • If the payment arrangements included the Sponsor providing funding for services that were not rendered, be sure that the Sponsor didn’t require any funds to be returned such as additional “per patient” costs, travel or patient care costs. A letter will be required from the Sponsor in this type of arrangement to allow the funds to be used for other categories or purposes, including moving any remainder into a miscellaneous donors account.

29. Expenses Not AllowedPer UF Policy (Compliance Monitoring) • All supplies, and equipment received on or after the expiration of a grant or contract or expenses incurred after such date, are not considered to be allowable charges to the account because such charges do not benefit the grant or contract.

30. Generally Not AllowedPer UF Policy (Compliance Monitoring) • Advertising. • Bad debts. • Capital expenditures • Improvements to land,buildings and equipment, buildings and repairs which materially increase the value or life of equipment or buildings, unless provided for in the award documents. • Contingency reserve. • Entertainment costs - Amusement, social activities, entertainment and related costs such as meals, lodging, rentals, transportation and gratuities. • Fines and penalties - Costs resulting from violations of, or failure to comply with, federal, state and local laws and regulations. • Insurance and indemnification - Actual losses that could have been covered by permissible insurance. • Revised OMB Circular A-21 allows certain interest charges, fund raising and investment management costs, but many are not allowable. • Losses on grants and contracts - Any excess of costs over the awarded amount. • Public information costs - News releases. • Special administrative costs - general public relations activities, catalogs, alumni activities and similar activities. • Travel costs - First class accommodations. • Student aid charged to research projects.

31. Generally Not Allowed Per UF Policy (Controller’s Office) • Items that would appear to be of a personal nature, rather than directly benefiting the University would normally not be allowed. Examples of items that are not normally allowed are listed below: • alcoholic beverages • portable heaters • fans • refrigerators • stoves • microwaves • coffee pots and supplies • picture frames • wall hangings • various decorations • first class travel  • food items • gifts  • political contributions

32. Generally Not AllowedPer UF Policy (Controller’s Office) • Alcohol • Awards • Contributions to Charitable or Political Organizations  • Educational Courses (Restricted - must read rules) • Entertainment • Equipment Leases • Honorarium • Levies • Lobbyist • Memberships (Restricted - must read rules) • Moving Expenses  • Non Resident Alien Payments (NRA - Individuals or Corporations) • Payments with Component Unit Moneys - Foundation and AEF • Payments to Research Participants (Restricted - must read rules) • Perquisites • Promotional Items • Sales Tax

33. Generally Not AllowedPer UF Policy (DSR) • Indirect costs…that cannot be tied specifically to a project, such as libraries, janitorial services, utilities, maintenance and depreciation of facilities, and general administrative costs. • Consultant Services (unless justified and in budget). • Equipment (unless justified and in budget). • Office Supplies (unless project specific and justified in budget). • Alterations and Renovations (unless approved by sponsor).

34. Patient Costs & Participant Support • Must be allocable to this project. • Voucher must reference activity within IRB dates.

35. “__Check ledger for previous residual transfers 811000…” • Look for account code 811000. • If you find, let C&G know. • This indicates that some residual has already been transferred from the project and must be taken into consideration when C&G prepares the Close Memo.

36. “__Ensure that all employees are removed from the Payroll Distribution for the project.” • Contact payroll person. • No one should be on a distribution past the BUDGET end date. • Use caution when doing retros on other projects that may have the same employees.

37. “__Check for cost sharing being met (if applicable).” • If on NOA, has Cost Sharing been met? • Grants<Awards<Project Summary Page • Cost Sharing Report Hyperlink • If not, contact the C&G Research Administrator in charge of the project.

38. “__If residual is more that 25% of award or over $10,000.00, have PI prepare a letter of explanation.” • Explanation should not include the following type of statements: • “Expenses were posted to a misc. donors project and this will reimburse it” • “We don’t know where expenses are” • “There were errors” • “Expenses are on another project”

39. “__Email correct C&G Research Administrator to request a close memo…” • Be sure to attach: • Sponsor Payment History Summary (and explanation if it differs from award); • AR_ACTIVITY_BY_CONTRACT query; • UF_GM_PC_GL_KK_COMPARISON query; • UF_GM_FINAL_CLOSE_OUT_QUERY; • UF_GM_PROJ_RES_RECON_FINAL query; • Written Permission back-up for “Unallowable” items; • PI letter of explanation if high residual.

40. How to Track Your Close-out • Use Industry G00070 Closeout Status spreadsheet: • Go to http://fa.ufl.edu/cg/. • Open Excel spreadsheet “Industry G000770 Closeout Status” . • Edit<Find – Enter project #. • Spreadsheet updated weekly.

41. What Changes Can Be Made Now To Help With Future Issues? • Discuss the need for “Payment History Summaries” with Sponsor when preparing the original agreement – At least quarterly. Get in writing. • Obtain and keep copies of CRF Cover Sheets/Invoices (ensure that patient info is kept confidential). Send to C&G (specific RA). • Send set of invoices and PHS Summary when requesting the close. • Ask for Start-up Costs from Sponsor. • Have pre-and post protocol time periods for posting expenses. • Need clear and consistent written policies from all UF groups. • Clarity on allocability of expenses by C&G Offices. • When in doubt, put restricted or “generally not allowed” expenses into your contracts – Get sponsor permission ahead of time!