Lets RAP

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Lets RAP
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• (Research Administration Processes)
• In our interactive RAP session, panelists will
  discuss issues which affect our RAP.
• Find out what you can do to facilitate the
  process!
• Research Administration Support Group (RASG)
• Tuesday, November 15, 2005

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Panelists

• Barbara Longmire.............Director, Office of
  Clinical Trials........................ ...Pre
  Award
• Barbara Lyons.........Financial Analyst,
  Comprehensive Cancer Center..........Pre Award
• Cathy Rogers..........Contract Specialist, Office
  of Sponsored Research.........Pre Award
• Ellen Ludington...Deputy Director for Research
  Development, Psychiatry. ..Pre Award
• Kelly Musty...........Financial Analyst, Office
  of Sponsored Research .............Post Award
• Dianne Blake....Sr. Accounting Specialist,
  Highway Safety Research Ctr.....Post Award

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Welcome to the UNC-CH Office of Clinical Trial

• Barbara Longmire, RN, MSN, Director

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Location

• Current Location
• 200 S. Elliott Rd.
• January, 2006
• Bioinformatics

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OCTs Mission

• Consistent with UNC's mission to acquire,
  discover, preserve, synthesize and transmit
  knowledge and provide an environment for
  research, the Office of Clinical Trials (OCT)
  will perform all administrative, legal, and
  pre-award budgetary functions for clinical
  trials.

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The People

• Administrative Assistant Ginger Morgan
• Project Manager Sabrena Mervin-Blake, MSCR
• Contract Manager Erika Nunn, MS, JD
• Contract Manager Janet Devine, BA
• Contract Manager Aylin Regulski, MS, JD
• Director Barbara Longmire, RN, MSN

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Processing a Clinical Trial Agreement
Pharma
CRO
Other Funding Agency
Principal Investigator
internal feasibility review
Office of Clinical Trials (submit with RRF)

• Submit CTA/CDA/Amendment upon receipt
• Submit IPF when complete
• OCT will review/negotiate contract terms as
  needed and contact PI/Department for signature on
  agreement

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Contract Review and Approval

• Negotiate terms of all agreements related to
  clinical trials, such as
• Confidentiality Disclosure Agreements (CDAs)
• NOT signed by PI
• Clinical Trial Agreements (CTAs)
• Amendments
• Subcontracts
• Other
• Sign agreements on behalf of the University

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IPF/Proposal Packet Review and Approval

• Full review within OCT
• Accurate IPF and Internal Budget that matches the
  dollar amount in the contract
• IRB Fee
• Pharmacy Fee if applicable
• Correct FA rate applied to all appropriate costs
• Current IRB approval/pending letter AND informed
  consent
• Provide help desk assistance for document
  preparation
• Final University signature approval of IPF

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Processing an Amendment to the Clinical Trial
Agreement
Does the amendment change the financial terms of
the contract?
Yes
No

• Submit the following to the OCT
• Amendment
• Review Request Form
• Hard copy Proposal Packet (IPF)

Does the amendment change the timeline and/or PI
only?
Yes
No
Submit the following to the OCT Amendment Review
Request Form
SIGN the amendment, thensubmit the following to
the OCTSigned amendment Review Request Form
Proposal packets for amendments must include a
copy of the most recent IRB approval, informed
consent form, and the most current protocol in
addition to the required forms. If the protocol
has not changed, a emm0o stating so will be
acceptable
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OCT Review Request Form (RRF)
http//research.unc.edu/oct/ Must
accompany every submission
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OCT Web site
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Research Administration Process-Clinical Trials

• Barbara M. Lyons
• Financial Analyst
• Lineberger Cancer Center
• 919-843-6902
• blyons_at_med.unc.edu

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Agenda

• Review Request Form
• Budget and Contract
• Internal Budget
• Internal Process Form
• Useful Website

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Review Request Form

• Send this to OCT as soon as you receive the
  contract template
• Electronic Template send to OCT_at_UNC.EDU
• Estimated Length of Study
• PI answer questions on Intellectual Property,
  Publication, and PI sign

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Review of Budget and Contract

• Negotiate Budget with Sponsor
• Make sure all costs are covered
• Dont be afraid to ask for items not in template
• Contract Terms
• Read the whole contract
• Check for Payment Terms
• Pay attention to any items that will affect the
  department
• What is expected of site
• Definitions of Protocol Violations-nonpayment

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Internal Budget

• Complete after negotiating budget with sponsor
• Keep it simple
• NO F_at_A on IDS or IRB Fee
• Address items outside of normal budget
• Reimbursed Items-Hotel Stays/MRI/etc

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Internal Budget

• Personnel
• Patient Care Costs
• Pharmacy Costs
• IRB
• Admin Fee
• Total Direct
• F_at_A
• Total
• Items on case by case basis and Reimbursed items
  list below budget

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Internal Processing Form

• Complete IPF when study is at the IRB for Review
• Total Budget Period-Be realistic about end date.
• LCCC 2-4 years
• Use Internal Budget for IPF Budget
• First year and total will be same
• Allow a few days for signature process
• Make a copy Department of Medicine
• Once you have one with no errors-use Copy
  function
• RAD-Do not include-Confidentiality of Protocol

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IPF-What to Include

• Internal budget
• Contract template
• IRB review letter/approval
• Consents
• Protocol

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Website

• http//cfx3.research.unc.edu/my_clinical_trials/

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PRE AWARD SERVICES

• Cathy Rogers
• Contract Specialist, Office of Sponsored Research

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PRE AWARD SERVICES

• Transition from UNC Department to Central
  Department (Office of Sponsored Research)
• Pre Award Proposal Routing within OSR

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Front Desk (Receptionist)
Proposal Specialist
Contract Specialist
Proposal Specialist
Front Desk (Receptionist)
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Pre Award Topics

• Amendment/Supplements
• No-Cost Extension Requests
• Project Financial Guarantees

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Office of Sponsored Research Website

• http//research.unc.edu/osr/
• Information Sheet

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Pre Award Services

• Ellen Ludington
• and
• Amanda Bundren
• Department of Psychiatry
• Business Office
• UNC School of Medicine

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What grants will we submit this month?

• Keep track of all grant submissions on grant
  project board
• Talk with Principal Investigator about grant type
  
• Review guidelines early
• Work with Principal Investigators support
  personnel
• Keep in touch with the Principal Investigator
  during the month for updates on his/her progress.

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Determine personnel for grant application

• Work with Principal Investigator to determine
  personnel
• Budget salaries correctly (include escalation for
  future years)
• Resolve all personnel cost share issues
• Use current and correct fringe benefit rates
• Information sheet can be found at
• http//research.unc.edu/osr/information/general_in
  fo.php

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Budget for all other grant expenses

• Review guidelines to determine allowable amounts
  for other expenses such as consultants, travel,
  supplies, and other costs.
• Justify all other costs

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Fellowship Awards

• Review guidelines
• Is employee eligible to apply for the fellowship
  award?
• Has a mentor/sponsor been identified?
• Is nominee letter required?
• If so, include in grant package when submitting
  to the University for review.

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Subcontracts

• Scope or Statement of Work
• Face Page
• Budget
• Budget Justification
• Checklist (NIH)
• FA Agreement
• Letter of Intent

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• Indirect Cost (Facilities and Administrative)
• Check guidelines for allowable rate, allowable
  rates vary, especially on Foundation grants
• Cost sharing and cost matching
• Check guidelines for requirements, work out all
  issues before routing grant for approval

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Conclusion

• Review guidelines
• (include guidelines in packet to OSP or OSR)
• Plan ahead as much as possible
• Information sheet can be found at
• http//research.unc.edu/osr/information/general_in
  fo.php

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OSR POST AWARD FORMS

• Kelly Musty
• Financial Analyst
• Office of Sponsored Research

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TYPES OF FORMS

• Just to name a few
• Travel
• Check Request
• Adjustments
• Petty Cash Reimbursements
• Purchase Requisitions
• IPAS

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WHAT SLOWS DOWN THE PROCESS???

• No justification
• Poor justification
• Over drawn accounts
• Unallowable cost
• Incorrect backup
• Charges not within grant period dates

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EXAMPLES OF INCORRECT JUSTIFICATION

• Account Adjustment
• To move charge to correct account.
• 2nd try at justification
• The attached charges were incorrectly charged
  wrong account. This entry is needed to post them
  to the correct account.

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EXAMPLES CONT

• To cover over draft of account ending
• To pay criminal background checks
• Reimburse default accounts for P-Card charges
• Charge was not allowed by agency AJ to move
  expenses off account

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EXAMPLES CONT

• IPAS FOREIGN TRAVEL
• Unique opportunity to consult with international
  colleagues
• Establish themselves internationally

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EXAMPLES CONT

• IPAS FOR PURCHASE REQUISITION
• Do not use sole source justification for IPAS
  justification
• To expand the project
• Equipment will be used in common labs

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EXAMPLES CONT

• Travel Forms
• Purpose of trip Attend meeting
• Put travel reimbursement on grant 5-5XXXX or
  5-3XXXX whichever one has money

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ANSWERING TO A HIGHER POWER

• The different sponsoring agencies make the
  guidelines
• Auditors check for compliance to program
  guidelines
• Such as
• Unallowable costs
• Timeliness and accuracy of reports
• Time and Effort Reporting
• Cost sharing
• Cost Transfer
• OSR is entrusted with responsibility of insuring
  compliance to the guidelines.

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• HOW DOES THIS CHARGE OR ACTION BENEFIT THIS GRANT?

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How to Close Out an Award

• 6 stages to Closing an Account Successfully
• Post Award Services
• Dianne Blake
• Senior Accounting Specialist
• Highway Safety Research Center

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1ST Stage

• Approximately 60 days prior to the expiration of
  the project account, the department should
  receive a notification/reminder to the PI of the
  terminating account, asking if an extension will
  be needed and the need for a final progress
  report.
• HSRC meets with the PI 6 months prior the project
  end date to review the expenses
• Reallocate funds to ensure all expenses will be
  covered and to ensure the funds can be expended
  by the project end date
• This is the opportune time for the PI to review
  their accounts closely, and request an extension
  if needed.

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2nd Stage

• A Notice of Termination Reply (NOTR) letter and
  form is sent to the department administrator.
  The administrator should complete and return the
  NOTR to OSR post award services by the date
  stated in the NOTR letter and form.
• Make sure all project costs are projected
• Ensure all costs are legit
• Remove all costs that may not be allowable or
  appropriate
• Treat the NOTR like your personal check book (on
  the other hand maybe not).

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NOTR Formhttp//research.unc.edu/osr/documents/no
tr_protected.xls
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3rd Stage

• The following reports are generally due for all
  sponsored projects at termination. Most sponsors
  require submission 90 days after expiration. You
  should refer to each projects term and
  conditions for required reports and due dates.
• final technical, progress, narrative
  report-submitted by PI
• final inventions report submitted by the PI,
  counter signed by Office of Technology, mailed to
  sponsor by OSR
• final financial report submitted by OSR upon
  approval of expenditures by the PI
• final property report submitted by OSR
  University Property Administrator

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4th Stage

• Upon project termination, the Financial Reporter
  will review the account and work with the
  department administrator submitting the NOTR to
  determine the final figure to be reported to the
  sponsor on the financial report or final invoice.
  
• The department administrator needs to ensure the
  following
• All staff payroll has been removed
• All cash advances must be reconciled
• All erroneous charges have been transferred, any
  deficits and post-term charges have been cleared
• All internal service centers have been notified
  of the account termination for any future costs
  such as printing, telephone postage

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5th Stage

• Final financial reports and final invoices must
  be submitted no later than 90 days from the close
  date for federal awards state and private agency
  deadlines may vary and have stricter
  stipulations.
• In order to meet sponsor deadlines there needs to
  be a clear and timely communication between PIs,
  department administrators, and Financial
  Reporting. OSR Financial Reporting will submit
  the final financial report/invoice to the sponsor
  once they have coordinated with the department
  the final figure to be reported.
• However, failure to return the NOTR by the
  required due date will result in OSR preparing
  filing the Financial Report based on the current
  Budget Expenditure Report (FBM090/91) to avoid
  compliance issues and audit finding for late
  reporting.

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Definitions

• Deficits more commonly referred to as
  overdrafts occur when cumulative expenses
  exceed the amount awarded by the sponsor and
  could be considered voluntary uncommitted cost
  sharing. It is the responsibility of the
  department to transfer deficits out of sponsored
  awards promptly and no later than 90 days after
  the termination date.
• Post-Term Charges charges incurred after the
  termination date of a project/award. Under some
  circumstances, the costs of final report
  preparation may be incurred after the end date,
  and so should be carefully documented.
• Most common examples payroll expenses, Pcard
  expenses, telephone costs, copy services, MMD
  charges and service center charges

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6th Stage

• Final Adjustments/ Closing Entries
• OSR will notify the department 120 days after
  termination of any deficits/overdrafts, which
  must be reconciled within 30 days to avoid the
  OSR closing the account by off setting the
  overdraft against the departments overhead
  receipt account.
• The University is responsible for closing
  accounts in a timely manner to avoid the
  appearance of having

LACK OF INTERNAL CONTROL AND COMPLIANCE
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JUSTIFICATION RAP

• So you want to take a trip
• Remember to tell us why
• How to the grant does it apply
• You always need to justify
• Cost transfers problems may exist.
• Do it right the first time no need to fix.
• When problem is found correct right away
• Dont do any past ninety days!
• How did error occur how to correct
• Why the grant is paying to the grant it must
  connect
• Just If I want to charge the grant how does it
  apply
• If it doesnt pass the test it will be nullified

• CHORUS
• Jus-ti-fy, Jus-ti-fy,
• Always remember you
• must jus-ti-fy 

• l

CHORUS
CHORUS
CHORUS