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Let’s “RAP”

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:.

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Let’s “RAP”

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  1. 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

  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. 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.

  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 (CDA’s) • NOT signed by PI • Clinical Trial Agreements (CTA’s) • 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 F&A rate applied to all appropriate costs • CurrentIRB 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 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

  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@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@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 • Don’t 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@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@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. MY IMPORTANT RESEARCH PROPOSAL MY IMPORTANT RESEARCH PROPOSAL 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 Investigator’s 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_info.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) • F&A 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_info.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 correctaccount.

  39. 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

  40. EXAMPLES CON’T • IPAS FOREIGN TRAVEL • Unique opportunity to consult with international colleagues • Establish themselves internationally

  41. 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

  42. EXAMPLES CON’T • 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. HOWDOES 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/notr_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 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

  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

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