♫♫♫
Let’s “RAP” ♫♫♫
(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
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
Welcome to the UNC-CH
Office of Clinical Trial
Barbara Longmire, RN, MSN, Director
Location
Current Location
200 S. Elliott Rd.
January, 2006
Bioinformatics
OCT’s 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.
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
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
Contract Review and Approval

Negotiate terms of all agreements related to clinical
trials, such as:
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Confidentiality Disclosure Agreements (CDA’s)
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NOT signed by PI
Clinical Trial Agreements (CTA’s)
Amendments
Subcontracts
Other
Sign agreements on behalf of the University
IPF/Proposal Packet
Review and Approval

Full review within OCT

Accurate IPF and Internal Budget that matches the dollar
amount in the contract
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IRB Fee
Pharmacy Fee if applicable
Correct F&A 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
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?
No
Submit the following to the OCT:
Amendment
Review Request Form
Yes
SIGN the amendment, then
submit the following to the OCT:
Signed 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
Required for all agreements related to clinical trials.
Please complete and send to the Office of Clinical Trials, 200 S. Elliott Road, CB #1651
Phone: 843-2698
Fax: 843-2399
email: oct@unc.edu
TYPE OF AGREEMENT:
Is electronic version available from the department?
OCT
Review
Request
Form
(RRF)
http://research.unc.edu/oct/
******
Must accompany every
submission
Yes
No
If yes, please forward to oct@unc.edu ASAP
Principal Investigator:
Administrative Department Name and Number:
Division:
Phone:
Pager:
Mailing address (CB #) for payment:
Physical (FEDEX) address:
E-Mail:
Fax:
Protocol Number and Title:
GCRC/IRB #:
Estimated Start Date for Study:
Type of Trial:
Drug Trial
Device Trial
Date Submitted to GCRC and/or IRB:
Estimated Length of Study:
< 2 yrs
Drug or device provided/No Funding
2-4 yrs
Other
> 5 yrs
Primary Dept. Contact for Questions:
Name:
Phone:
E-Mail:
CB#:
Fax:
Pager:
Primary Sponsor Contact
for Contract Questions:
Sponsor:
Primary CRO Contact (if applicable)
for Contract Questions:
CRO:
Contact Name:
Phone:
Fax:
E-mail:
Address:
Contact Name:
Phone:
Fax:
E-mail:
Address:
IF THIS RRF IS FOR A CONFIDENTIALITY AGREEMENT OR AMENDMENT, STOP HERE.
NO SIGNATURE IS REQUIRED!!
IF THIS RRF IS FOR A CLINICAL TRIAL AGMT, ANSWER FOLLOWING QUESTIONS ACCURATELY
AND SIGN THE FORM. THIS INFO MAY BE FORWARDED TO OFFICE OF UNIVERSITY COUNSEL
Will subcontacts be required?
Yes
No
If yes, approximately how many? __________
Are there multiple sponsors?
Intellectual Property Concerns:
Yes
No
Did the PI design the protocol?
Is there a likelihood of an invention resulting from this study?
Do you consent to the Sponsor owning any invention resulting from the study?
Yes
Yes
Yes
No
No
No
Yes
Yes
No
No
Publication Concerns:
Is a publication delay of >12 months acceptable to you?
Do you consent to transfer your copyright of any written materials produced in relation to this
study to the sponsor?
I hereby certify that all the information provided above is true and correct and the ORIGINAL signature below is
my own.
PI Signature: ______________________________________
Date: ____________________
OCT Web site
Research
Administration
Process-Clinical Trials
Barbara M. Lyons
Financial Analyst
Lineberger Cancer Center
919-843-6902
blyons@med.unc.edu
Agenda
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Review Request Form
Budget and Contract
Internal Budget
Internal Process Form
Useful Website
Review Request Form
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Send this to OCT as soon as you receive the
contract template
Electronic Template send to OCT@UNC.EDU
Estimated Length of Study
PI answer questions on Intellectual Property,
Publication, and PI sign
Review of Budget
and Contract

Negotiate Budget with Sponsor
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Make sure all costs are covered
Don’t be afraid to ask for items not in template
Contract Terms
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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
Internal Budget
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Complete after negotiating budget with sponsor
Keep it simple
NO F@A on IDS or IRB Fee
Address items outside of normal budget
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Reimbursed Items-Hotel Stays/MRI/etc
Internal Budget
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•
Personnel
Patient Care Costs
Pharmacy Costs
IRB
Admin Fee
Total Direct
F@A
Total
Items on case by case basis and Reimbursed items list
below budget
Internal Processing Form
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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
IPF-What to Include
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Internal budget
Contract template
IRB review letter/approval
Consents
Protocol
Website
http://cfx3.research.unc.edu/my_clinical_trials/
PRE AWARD SERVICES
Cathy Rogers
Contract Specialist, Office of Sponsored
Research
PRE AWARD SERVICES

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Transition from UNC Department to
Central Department (Office of Sponsored
Research)
Pre Award Proposal Routing within OSR
Front Desk
(Receptionist)
Proposal Specialist
Contract Specialist
Proposal Specialist
Front Desk
(Receptionist)
Pre Award Topics

Amendment/Supplements
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No-Cost Extension Requests
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Project Financial Guarantees
Office of Sponsored
Research Website

http://research.unc.edu/osr/

Information Sheet
Pre Award Services
Ellen Ludington
and
Amanda Bundren
Department of Psychiatry
Business Office
UNC School of Medicine
What grants will we submit this month?
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Keep track of all grant submissions on grant
project board
Talk with Principal Investigator about grant type
Review guidelines early
Work with Principal Investigator’s support
personnel
Keep in touch with the Principal Investigator
during the month for updates on his/her
progress.
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_info.php
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

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.

Subcontracts
Scope or Statement of Work
 Face Page
 Budget
 Budget Justification
 Checklist (NIH)
 F&A 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
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_info.php

OSR
POST AWARD FORMS
Kelly Musty
Financial Analyst
Office of Sponsored Research
TYPES OF FORMS

Just to name a few…
 Travel
 Check
Request
 Adjustments
 Petty Cash Reimbursements
 Purchase Requisitions
 IPAS
WHAT SLOWS DOWN THE
PROCESS???
No justification
 Poor justification
 Over drawn accounts
 Unallowable cost
 Incorrect backup
 Charges not within grant period dates

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.
EXAMPLES CON’T
 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
EXAMPLES CON’T

IPAS FOREIGN TRAVEL
 Unique
opportunity to consult with
international colleagues
 Establish themselves internationally
EXAMPLES CON’T

IPAS FOR PURCHASE REQUISITION
 Do
not use sole source justification for IPAS
justification
 To expand the project
 Equipment will be used in common labs
EXAMPLES CON’T
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Travel Forms
 Purpose
of trip – Attend meeting
 Put travel reimbursement on grant 5-5XXXX
or 5-3XXXX whichever one has money
ANSWERING TO A HIGHER
POWER
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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.
HOW DOES THIS
CHARGE OR ACTION
BENEFIT THIS
GRANT?
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
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.
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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.
nd
2
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.
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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).
NOTR Form
http://research.unc.edu/osr/documents/notr_protected.xls
rd
3
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 project’s term and conditions
for required reports and due dates.
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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
th
4
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
th
5
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 PI’s, 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.
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
th
6
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
JUSTIFICATION RAP
CHORUS:
l
Jus-ti-fy, Jus-ti-fy,
Always remember you
must jus-ti-fy
So you want to take a trip
Remember to tell us why
How to the grant does it apply
You always need to justify
CHORUS
Cost transfers – problems may exist.
Do it right the first time – no need to fix.
When problem is found – correct right away
Don’t do any past ninety days!
How did error occur – how to correct
Why the grant is paying – to the grant it
must connect
CHORUS
Just If I want to charge the grant – how does
it apply
If it doesn’t pass the test – it will be nullified
CHORUS