Industry (G000770) Clinical Trial Pre-Closeout Checklist

1
Industry (G000770) Clinical Trial Pre-Closeout
Checklist

• Informal Presentation to COM
• 11/10/08
• Edy Zettler
• CG Research Administrator II
• Industry and Foundations Team Lead
• ezettler_at_ufl.edu

2
Things to Know Before You Start

• Know the Project , Contract , Chartfield String
  and KK Level for the project.
• Project
• From NOA
• GrantsltAwardsltAward Summary Page
• From NOA
• GrantsltAwardsltProject Summary Page
• Chartfield String (Department, Fund, Program,
  Source of Funds)
• From NOA
• GrantsltAwardsltProject Summary Page
• GrantsltAwardsltProject Budget
• KK Budget Level
• From NOA
• GrantsltAwardsltProject 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 CG 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 CG Industry (G000770) Contacts (as of
11/10/08)

• Industry NON-Clinical Trials
• All Departments
• Becky Hyde blhyde_at_ufl.edu
• Industry Clinical Trials
• Departments 00000000-29149999
• Erin Whitten erexvb_at_ufl.edu
• Departments 29150000-57999999
• Carlene Reddick reddickc_at_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_at_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 CG 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 CG.
• Checklist is available from your CG 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 .
• EditltFind 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
• GrantsltAwardsltProject Project General tab has
  a Status of Inactive
• Your CG contact tells you it was.?

10
__Check in PS. Are there any subprojects related
to this closeout?

• How do I find related Projects?
• GrantsltAwardsltAward 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 first NOA 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 have Budgets Overview inquiry run control
  set up (Instructions available on the web at
  www.hr.ufl.edu/training/myufl/toolkits).
• Commitment ControlltReview Budget
  ActivitiesltBudgets 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 FA Base ID and FA Rate for
  this project
• See NOA or
• GrantsltAwardsltProject Summary Page.
• IF FA Base ID is TDC, review Budgets Overview
  NOA to calculate correct Direct /Indirect
  Budgets
• Direct Total Award Amount / 1.xx, where xx is
  the FA 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 FA Base ID is MTDC, you must exclude
  exemptions. Ask for help from your CG 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 Sponsors Accounts Payable Department or
  Sponsors 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 CG 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 CG 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.

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Where are the Queries?

• PeopleSoft ltFinancials People ToolsltReporting
  ToolsltQueryltQuery 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 CG.

• 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 (UFs official accounting
  record)
• PC- Project Costing in Project Resource (billing,
  calculates FA, 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?doc1.
  4.5.6
• UF Policy (Controllers Office)
  http//fa.ufl.edu/uco/handbook/handbook.asp?doc1.
  4.13.3
• UF Policy (DSR) http//research.ufl.edu/resea
  rch/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 (Controllers 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 didnt 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 didnt 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
(Controllers 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 (Controllers
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 coststhat 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 CG know.
• This indicates that some residual has already
  been transferred from the project and must be
  taken into consideration when CG 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?
• GrantsltAwardsltProject Summary Page
• Cost Sharing Report Hyperlink
• If not, contact the CG 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 dont know where expenses are
• There were errors
• Expenses are on another project

39
__Email correct CG 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 .
• EditltFind 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 CG (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 CG
  Offices.
• When in doubt, put restricted or generally not
  allowed expenses into your contracts Get
  sponsor permission ahead of time!