Title: Lets RAP
1Lets 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
2Panelists
- 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
3Welcome to the UNC-CH Office of Clinical Trial
- Barbara Longmire, RN, MSN, Director
4Location
- Current Location
- 200 S. Elliott Rd.
- January, 2006
- Bioinformatics
5OCTs 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.
6The 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
7Processing 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
8Contract 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
9IPF/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
10Processing 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
11OCT Review Request Form (RRF)
http//research.unc.edu/oct/ Must
accompany every submission
12OCT Web site
13Research Administration Process-Clinical Trials
- Barbara M. Lyons
- Financial Analyst
- Lineberger Cancer Center
-
- 919-843-6902
- blyons_at_med.unc.edu
14Agenda
- Review Request Form
- Budget and Contract
- Internal Budget
- Internal Process Form
- Useful Website
15Review 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
16Review 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
17Internal 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
18Internal 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
19Internal 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
20IPF-What to Include
- Internal budget
- Contract template
- IRB review letter/approval
- Consents
- Protocol
21Website
- http//cfx3.research.unc.edu/my_clinical_trials/
22PRE AWARD SERVICES
- Cathy Rogers
- Contract Specialist, Office of Sponsored Research
23PRE AWARD SERVICES
- Transition from UNC Department to Central
Department (Office of Sponsored Research) - Pre Award Proposal Routing within OSR
24Front Desk (Receptionist)
Proposal Specialist
Contract Specialist
Proposal Specialist
Front Desk (Receptionist)
25Pre Award Topics
- Amendment/Supplements
- No-Cost Extension Requests
- Project Financial Guarantees
26Office of Sponsored Research Website
- http//research.unc.edu/osr/
- Information Sheet
27Pre Award Services
- Ellen Ludington
- and
- Amanda Bundren
- Department of Psychiatry
- Business Office
- UNC School of Medicine
28What 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.
29Determine 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
30Budget 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
31Fellowship 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.
32Subcontracts
- 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
34Conclusion
- 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
35OSR POST AWARD FORMS
- Kelly Musty
- Financial Analyst
- Office of Sponsored Research
36TYPES OF FORMS
- Just to name a few
- Travel
- Check Request
- Adjustments
- Petty Cash Reimbursements
- Purchase Requisitions
- IPAS
37WHAT SLOWS DOWN THE PROCESS???
- No justification
- Poor justification
- Over drawn accounts
- Unallowable cost
- Incorrect backup
- Charges not within grant period dates
38EXAMPLES 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.
39EXAMPLES 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
40EXAMPLES CONT
- IPAS FOREIGN TRAVEL
- Unique opportunity to consult with international
colleagues - Establish themselves internationally
41EXAMPLES 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
42EXAMPLES CONT
- Travel Forms
- Purpose of trip Attend meeting
- Put travel reimbursement on grant 5-5XXXX or
5-3XXXX whichever one has money
43ANSWERING 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
461ST 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.
472nd 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).
48NOTR Formhttp//research.unc.edu/osr/documents/no
tr_protected.xls
493rd 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
504th 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
515th 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.
52Definitions
- 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
536th 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
54JUSTIFICATION 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-fyÂ
CHORUS
CHORUS
CHORUS