Let’s “RAP”Let’s “RAP”(Research Administration Processes)(Research Administration Processes)

In our interactive In our interactive RAPRAP session, panelists will session, panelists will discuss issues which affect our discuss issues which affect our RAP.RAP.

Find out what you can do to facilitate the Find out what you can do to facilitate the process!process!

Research Administration Support Group (RASG)Research Administration Support Group (RASG)Tuesday, November 15, 2005Tuesday, November 15, 2005

♫♫♫♫♫♫ ♫♫♫♫♫♫

Panelists:Panelists:

Barbara LongmireBarbara Longmire.............Director, Office of Clinical .............Director, Office of Clinical Trials........................Trials........................ ...Pre Award...Pre Award

Barbara LyonsBarbara Lyons.........Financial Analyst, Comprehensive Cancer .........Financial Analyst, Comprehensive Cancer Center..........Pre AwardCenter..........Pre Award

Cathy RogersCathy Rogers..........Contract Specialist, Office of Sponsored ..........Contract Specialist, Office of Sponsored Research.........Pre AwardResearch.........Pre Award

Ellen LudingtonEllen Ludington...Deputy Director ...Deputy Director forfor Research Development, Research Development, Psychiatry.Psychiatry. ..Pre Award..Pre Award

Kelly MustyKelly Musty...........Financial Analyst, Office of Sponsored ...........Financial Analyst, Office of Sponsored ResearchResearch .............Post Award.............Post Award

Dianne BlakeDianne Blake....Sr. Accounting Specialist, Highway Safety ....Sr. Accounting Specialist, Highway Safety Research Ctr.....Post AwardResearch Ctr.....Post Award

Welcome to the UNC-Welcome to the UNC-CH Office of Clinical CH Office of Clinical

TrialTrialBarbara Longmire, RN, MSN, Barbara Longmire, RN, MSN,

DirectorDirector

LocationLocation

Current LocationCurrent Location

200 S. Elliott Rd.

January, 2006January, 2006

BioinformaticsBioinformatics

OCT’s MissionOCT’s Mission

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

The PeopleThe People

Administrative Assistant – Administrative Assistant – Ginger MorganGinger Morgan

Project Manager – Project Manager – Sabrena Mervin-Blake, Sabrena Mervin-Blake, MSCRMSCR

Contract Manager – Contract Manager – Erika Nunn, MS, JDErika Nunn, MS, JD

Contract Manager – Contract Manager – Janet Devine, BAJanet Devine, BA

Contract Manager – Contract Manager – Aylin Regulski, MS, Aylin Regulski, MS, JDJD

Director – Director – Barbara Longmire, RN, MSNBarbara Longmire, RN, MSN

Processing a Clinical Trial Processing a Clinical Trial AgreementAgreement

Principal Investigator

Pharma CRO Other Funding Agency

internal feasibility review

• 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

Office of Clinical Trials (submit with RRF)

Contract Review and Contract Review and ApprovalApproval

Negotiate terms of all agreements related Negotiate terms of all agreements related to clinical trials, such as: to clinical trials, such as: Confidentiality Disclosure Agreements (CDA’s)Confidentiality Disclosure Agreements (CDA’s)

NOT signed by PINOT signed by PI Clinical Trial Agreements (CTA’s)Clinical Trial Agreements (CTA’s) AmendmentsAmendments SubcontractsSubcontracts OtherOther

Sign agreements on behalf of the Sign agreements on behalf of the UniversityUniversity

IPF/Proposal Packet IPF/Proposal Packet Review and ApprovalReview and Approval

Full review within OCTFull review within OCT Accurate IPF and Internal Budget that Accurate IPF and Internal Budget that

matches the dollar amount in the contractmatches the dollar amount in the contract IRB FeeIRB Fee Pharmacy Fee if applicablePharmacy Fee if applicable

Correct F&A rate applied to all appropriate Correct F&A rate applied to all appropriate costscosts

CurrentCurrent IRB approval/pending letter AND IRB approval/pending letter AND informed consentinformed consent

Provide help desk assistance for Provide help desk assistance for document preparation document preparation

Final University signature approval of IPFFinal University signature approval of IPF

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 Yes

Submit the following to the OCT:Amendment

Review Request Form

SIGN the amendment, thensubmit 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

Processing an Amendment to the Clinical Trial Agreement

http://research.unc.edu/oct/

******Must accompany every submission

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? Yes No If yes, please forward to oct@unc.edu ASAP Principal Investigator: Administrative Department Name and Number: Division: Mailing address (CB #) for payment: Phone: Physical (FEDEX) address: Pager: E-Mail: Fax: Protocol Number and Title: GCRC/ IRB #: Date Submitted to GCRC and/ or IRB: Estimated Start Date for Study: Estimated Length of Study: < 2 yrs 2-4 yrs > 5 yrs Type of Trial: Drug Trial Device Trial Drug or device provided/ No Funding Other Primary Dept. Contact for Questions:

Name: CB#: Phone: Fax: E-Mail: Pager: Primary Sponsor Contact Primary CRO Contact (if applicable) for Contract Questions: for Contract Questions: Sponsor: CRO: Contact Name: Contact Name: Phone: Phone: Fax: Fax: E-mail: E-mail: Address: 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? Yes No Intellectual Property Concerns: Did the PI design the protocol? Yes No Is there a likelihood of an invention resulting from this study? Yes No Do you consent to the Sponsor owning any invention resulting from the study? Yes No Publication Concerns: Is a publication delay of >12 months acceptable to you? Yes No Do you consent to transfer your copyright of any written materials produced in relation to this study to the sponsor?

Yes No

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 Review Request

Form (RRF)

OCT Web siteOCT Web site

Research Research Administration Administration Process-Clinical Process-Clinical

TrialsTrialsBarbara M. LyonsBarbara M. LyonsFinancial AnalystFinancial Analyst

Lineberger Cancer CenterLineberger Cancer Center

919-843-6902919-843-6902blyons@med.unc.edublyons@med.unc.edu

AgendaAgenda Review Request FormReview Request Form Budget and ContractBudget and Contract Internal BudgetInternal Budget Internal Process FormInternal Process Form Useful WebsiteUseful Website

Review Request FormReview Request Form Send this to OCT as soon as you Send this to OCT as soon as you

receive the contract templatereceive the contract template Electronic Template send to Electronic Template send to

OCT@UNC.EDUOCT@UNC.EDU Estimated Length of StudyEstimated Length of Study PI answer questions on Intellectual PI answer questions on Intellectual

Property, Publication, and PI signProperty, Publication, and PI sign

Review of Budget Review of Budget and Contractand Contract

Negotiate Budget with SponsorNegotiate Budget with Sponsor Make sure all costs are coveredMake sure all costs are covered Don’t be afraid to ask for items not in templateDon’t be afraid to ask for items not in template

Contract TermsContract Terms Read the whole contractRead the whole contract Check for Payment TermsCheck for Payment Terms Pay attention to any items that will affect the Pay attention to any items that will affect the

departmentdepartment What is expected of siteWhat is expected of site Definitions of Protocol Violations-nonpaymentDefinitions of Protocol Violations-nonpayment

Internal BudgetInternal Budget Complete after negotiating budget Complete after negotiating budget

with sponsorwith sponsor Keep it simpleKeep it simple NO F@A on IDS or IRB FeeNO F@A on IDS or IRB Fee Address items outside of normal Address items outside of normal

budgetbudget Reimbursed Items-Hotel Stays/MRI/etcReimbursed Items-Hotel Stays/MRI/etc

Internal BudgetInternal Budget PersonnelPersonnel Patient Care CostsPatient Care Costs Pharmacy CostsPharmacy Costs IRBIRB Admin FeeAdmin Fee Total DirectTotal Direct F@AF@A TotalTotal• Items on case by case basis and Items on case by case basis and

Reimbursed items list below budgetReimbursed items list below budget

Complete IPF when study is at the IRB for Complete IPF when study is at the IRB for ReviewReview

Total Budget Period-Be realistic about end date.Total Budget Period-Be realistic about end date.LCCC 2-4 yearsLCCC 2-4 years

Use Internal Budget for IPF BudgetUse Internal Budget for IPF Budget First year and total will be sameFirst year and total will be same Allow a few days for signature processAllow a few days for signature process Make a copy Department of MedicineMake a copy Department of Medicine Once you have one with no errors-use Copy Once you have one with no errors-use Copy

functionfunction RAD-Do not include-Confidentiality of ProtocolRAD-Do not include-Confidentiality of Protocol

Internal Processing FormInternal Processing Form

IPF-What to IncludeIPF-What to Include Internal budgetInternal budget Contract templateContract template IRB review letter/approvalIRB review letter/approval ConsentsConsents ProtocolProtocol

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

WebsiteWebsite

PRE AWARD PRE AWARD SERVICESSERVICES

Cathy RogersCathy Rogers

Contract Specialist, Office of Contract Specialist, Office of Sponsored ResearchSponsored Research

PRE AWARD SERVICESPRE AWARD SERVICES

Transition from UNC Department Transition from UNC Department to Central Department (Office of to Central Department (Office of Sponsored Research) Sponsored Research)

Pre Award Proposal Routing Pre Award Proposal Routing within OSRwithin OSR

MY IM

PORTANT

RESEARCH

PROPOSAL

Proposal Specialist

Contract Specialist

Front Desk(Receptionist)

Proposal Specialist

Front Desk(Receptionist)

MY IMPORTANT

RESEARCH

PROPOSAL

Pre Award TopicsPre Award Topics

Amendment/SupplementsAmendment/Supplements

No-Cost Extension RequestsNo-Cost Extension Requests

Project Financial GuaranteesProject Financial Guarantees

Office of Sponsored Office of Sponsored Research WebsiteResearch Website

http://research.unc.edu/osr/http://research.unc.edu/osr/

Information SheetInformation Sheet

Pre Award Pre Award ServicesServicesEllen LudingtonEllen Ludington

andandAmanda BundrenAmanda Bundren

Department of Psychiatry Department of Psychiatry Business OfficeBusiness Office

UNC School of MedicineUNC School of Medicine

Keep track of all grant submissions Keep track of all grant submissions on grant project boardon grant project board

Talk with Principal Investigator Talk with Principal Investigator about grant type about grant type

Review guidelines earlyReview guidelines early Work with Principal Investigator’s Work with Principal Investigator’s

support personnel support personnel Keep in touch with the Principal Keep in touch with the Principal

Investigator during the month for Investigator during the month for updates on his/her progress.updates on his/her progress.

What grants will we submit this What grants will we submit this month?month?

Work with Principal Investigator to Work with Principal Investigator to determine personnel determine personnel

Budget salaries correctly (include Budget salaries correctly (include escalation for future years)escalation for future years)

Resolve all personnel cost share Resolve all personnel cost share issuesissues

Use current and correct fringe Use current and correct fringe benefit ratesbenefit rates

Information sheet can be found at:Information sheet can be found at:http://research.unc.edu/osr/information/http://research.unc.edu/osr/information/

general_info.phpgeneral_info.php

Determine personnel for grant Determine personnel for grant applicationapplication

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

Justify all other costsJustify all other costs

Budget for all other grant Budget for all other grant expensesexpenses

Review guidelinesReview guidelines Is employee eligible to apply for Is employee eligible to apply for

the fellowship award?the fellowship award? Has a mentor/sponsor been Has a mentor/sponsor been

identified?identified? Is nominee letter required? Is nominee letter required?

If so, include in grant package If so, include in grant package when submitting to the when submitting to the University for review.University for review.

Fellowship AwardsFellowship Awards

Scope or Statement of WorkScope or Statement of Work Face PageFace Page BudgetBudget Budget JustificationBudget Justification Checklist (NIH)Checklist (NIH) F&A AgreementF&A Agreement Letter of IntentLetter of Intent

SubcontractsSubcontracts

Indirect Cost (Facilities and Indirect Cost (Facilities and Administrative)Administrative) Check guidelines for allowable rate, Check guidelines for allowable rate,

allowable rates vary, especially on allowable rates vary, especially on Foundation grantsFoundation grants

Cost sharing and cost matchingCost sharing and cost matching Check guidelines for requirements, Check guidelines for requirements,

work out all issues before routing work out all issues before routing grant for approvalgrant for approval

Review guidelines Review guidelines

(include guidelines in packet to (include guidelines in packet to OSP or OSR)OSP or OSR)

Plan ahead as much as possiblePlan ahead as much as possible Information sheet can be found Information sheet can be found

at:at:

http://research.unc.edu/osr/http://research.unc.edu/osr/information/general_info.phpinformation/general_info.php

ConclusionConclusion

OSR OSR POST AWARD POST AWARD FORMSFORMS

Kelly MustyKelly MustyFinancial AnalystFinancial Analyst

Office of Sponsored Office of Sponsored ResearchResearch

TYPES OF FORMSTYPES OF FORMS

Just to name a fewJust to name a few…… TravelTravel Check RequestCheck Request Adjustments Adjustments Petty Cash ReimbursementsPetty Cash Reimbursements Purchase Requisitions Purchase Requisitions IPASIPAS

WHAT SLOWS DOWN THE WHAT SLOWS DOWN THE PROCESS???PROCESS???

No justificationNo justification Poor justificationPoor justification Over drawn accountsOver drawn accounts Unallowable costUnallowable cost Incorrect backupIncorrect backup Charges not within grant period Charges not within grant period

datesdates

EXAMPLES OF INCORRECT EXAMPLES OF INCORRECT JUSTIFICATIONJUSTIFICATION

Account Adjustment Account Adjustment To move charge to correct account.To move charge to correct account.

22ndnd try at justification try at justification

The attached charges were The attached charges were incorrectly charged wrong account. incorrectly charged wrong account. This entry is needed to post them to This entry is needed to post them to the correctthe correct account.account.

EXAMPLES CON’TEXAMPLES CON’T

To cover over draft of account To cover over draft of account endingending

To pay criminal background To pay criminal background checkschecks

Reimburse default accounts for P-Reimburse default accounts for P-Card chargesCard charges

Charge was not allowed by agency Charge was not allowed by agency AJ to move expenses off accountAJ to move expenses off account

EXAMPLES CON’TEXAMPLES CON’T

IPAS FOREIGN TRAVELIPAS FOREIGN TRAVEL Unique opportunity to consult with Unique opportunity to consult with

international colleaguesinternational colleagues Establish themselves Establish themselves

internationallyinternationally

EXAMPLES CON’TEXAMPLES CON’T

IPAS FOR PURCHASE IPAS FOR PURCHASE REQUISITIONREQUISITION Do not use sole source justification Do not use sole source justification

for IPAS justificationfor IPAS justification To expand the projectTo expand the project Equipment will be used in common Equipment will be used in common

labslabs

EXAMPLES CON’TEXAMPLES CON’T

Travel FormsTravel Forms Purpose of trip – Attend meetingPurpose of trip – Attend meeting Put travel reimbursement on grant Put travel reimbursement on grant

5-5XXXX or 5-3XXXX whichever 5-5XXXX or 5-3XXXX whichever one has moneyone has money

ANSWERING TO A HIGHER ANSWERING TO A HIGHER POWERPOWER

The different sponsoring agencies make the The different sponsoring agencies make the guidelinesguidelines

Auditors check for compliance to program Auditors check for compliance to program guidelinesguidelines

Such as…Such as… Unallowable costsUnallowable costs Timeliness and accuracy of reportsTimeliness and accuracy of reports Time and Effort ReportingTime and Effort Reporting Cost sharingCost sharing Cost TransferCost Transfer

OSR is entrusted with responsibility of OSR is entrusted with responsibility of insuring compliance to the guidelines.insuring compliance to the guidelines.

HOWHOW DOES THIS DOES THIS CHARGE OR CHARGE OR

ACTION BENEFIT ACTION BENEFIT THIS GRANT?THIS GRANT?

How to Close Out an How to Close Out an AwardAward

6 stages to Closing an 6 stages to Closing an Account SuccessfullyAccount SuccessfullyPost Award ServicesPost Award Services

Dianne BlakeDianne BlakeSenior Accounting SpecialistSenior Accounting Specialist

Highway Safety Research Highway Safety Research CenterCenter

11STST Stage StageApproximately 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.

22ndnd Stage StageA 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).

NOTR FormNOTR Formhttp://research.unc.edu/osr/documents/notr_prhttp://research.unc.edu/osr/documents/notr_pr

otected.xlsotected.xls

33rdrd Stage StageThe 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.

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

44thth Stage StageUpon 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

55thth Stage StageFinal 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.

DefinitionsDefinitionsDeficits: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: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

66thth Stage StageFinal 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 havingLACK OF INTERNAL

CONTROL AND COMPLIANCE

So you want to take a tripSo you want to take a tripRemember to tell us whyRemember to tell us why

How to the grant does it applyHow to the grant does it applyYou always need to justifyYou always need to justify

Cost transfers – problems may Cost transfers – problems may exist.exist.

Do it right the first time – no need Do it right the first time – no need to fix.to fix.

When problem is found – correct When problem is found – correct right awayright away

Don’t do any past ninety days!Don’t do any past ninety days!How did error occur – how to How did error occur – how to

correctcorrectWhy the grant is paying – to the Why the grant is paying – to the

grant it must connectgrant it must connect

Just If I want to charge the grant – Just If I want to charge the grant – how does it applyhow does it apply

If it doesn’t pass the test – it will If it doesn’t pass the test – it will be nullifiedbe nullified

JUSTIFICATION RAPJUSTIFICATION RAPCHORUS:CHORUS:

Jus-ti-fy, Jus-ti-fy,Jus-ti-fy, Jus-ti-fy,

Always remember Always remember you you

must jus-ti-fymust jus-ti-fy  

CHORUSCHORUS

CHORUSCHORUS

CHORUSCHORUS