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Lets RAP

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Barbara Longmire.Director, Office of Clinical Trials.Pre Award ... all administrative, legal, and pre-award budgetary functions for clinical trials. ... – PowerPoint PPT presentation

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Title: Lets RAP


1
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

2
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

3
Welcome to the UNC-CH Office of Clinical Trial
  • Barbara Longmire, RN, MSN, Director

4
Location
  • Current Location
  • 200 S. Elliott Rd.
  • January, 2006
  • Bioinformatics

5
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.

6
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

7
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

8
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

9
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

10
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
11
OCT Review Request Form (RRF)
http//research.unc.edu/oct/ Must
accompany every submission
12
OCT Web site
13
Research Administration Process-Clinical Trials
  • Barbara M. Lyons
  • Financial Analyst
  • Lineberger Cancer Center
  • 919-843-6902
  • blyons_at_med.unc.edu

14
Agenda
  • Review Request Form
  • Budget and Contract
  • Internal Budget
  • Internal Process Form
  • Useful Website

15
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

16
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

17
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

18
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

19
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

20
IPF-What to Include
  • Internal budget
  • Contract template
  • IRB review letter/approval
  • Consents
  • Protocol

21
Website
  • http//cfx3.research.unc.edu/my_clinical_trials/

22
PRE AWARD SERVICES
  • Cathy Rogers
  • Contract Specialist, Office of Sponsored Research

23
PRE AWARD SERVICES
  • Transition from UNC Department to Central
    Department (Office of Sponsored Research)
  • Pre Award Proposal Routing within OSR

24
Front Desk (Receptionist)
Proposal Specialist
Contract Specialist
Proposal Specialist
Front Desk (Receptionist)
25
Pre Award Topics
  • Amendment/Supplements
  • No-Cost Extension Requests
  • Project Financial Guarantees

26
Office of Sponsored Research Website
  • http//research.unc.edu/osr/
  • Information Sheet

27
Pre Award Services
  • Ellen Ludington
  • and
  • Amanda Bundren
  • Department of Psychiatry
  • Business Office
  • UNC School of Medicine

28
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.

29
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

30
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

31
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.

32
Subcontracts
  • Scope or Statement of Work
  • Face Page
  • Budget
  • Budget Justification
  • Checklist (NIH)
  • FA Agreement
  • Letter of Intent

33
  • 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

34
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

35
OSR POST AWARD FORMS
  • Kelly Musty
  • Financial Analyst
  • Office of Sponsored Research

36
TYPES OF FORMS
  • Just to name a few
  • Travel
  • Check Request
  • Adjustments
  • Petty Cash Reimbursements
  • Purchase Requisitions
  • IPAS

37
WHAT SLOWS DOWN THE PROCESS???
  • No justification
  • Poor justification
  • Over drawn accounts
  • Unallowable cost
  • Incorrect backup
  • Charges not within grant period dates

38
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.

39
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

40
EXAMPLES CONT
  • IPAS FOREIGN TRAVEL
  • Unique opportunity to consult with international
    colleagues
  • Establish themselves internationally

41
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

42
EXAMPLES CONT
  • Travel Forms
  • Purpose of trip Attend meeting
  • Put travel reimbursement on grant 5-5XXXX or
    5-3XXXX whichever one has money

43
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.

44
  • HOW DOES THIS CHARGE OR ACTION BENEFIT THIS GRANT?

45
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

46
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.

47
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).

48
NOTR Formhttp//research.unc.edu/osr/documents/no
tr_protected.xls
49
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

50
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

51
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.

52
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

53
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
54
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
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