1 / 37

Office of Research Administration Update

Office of Research Administration Update . December 7, 2010. Changes at the ORA. ORA 2010 Changes. Accommodate expected growth of research at FH Greater collaboration with external entities UCF, Sanford-Burnham, etc. Investigator initiated studies Study Support Biostatistical

signa
Download Presentation

Office of Research Administration Update

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Office of Research AdministrationUpdate December 7, 2010

  2. Changes at the ORA

  3. ORA 2010 Changes • Accommodate expected growth of research at FH • Greater collaboration with external entities • UCF, Sanford-Burnham, etc. • Investigator initiated studies • Study Support • Biostatistical • Compliance & Education • Expansion of grant-seeking

  4. ORA 2010 Changes • Maintain pace with current research marketplace • Speed of study start-up • Time for legal review of contracts • Conflict of Interest • Debarment • Correct historical problems • Lack of infrastructure to support grants • P&Ps (timely review, updating, etc.) www.youtube.com/watch?v=m-KFTXIoQvY

  5. where documents go in, but may never come out…

  6. Donna GoraGrants Manager • Education • Masters in Administrative Science (Nonprofit Management) • Bachelors in Finance • Certificate in Federal Grants Management • Background • Grants Management • Training and Technical Assistance • Outcomes Based Evaluation • Technical Writing • Marketing Communications • Strategic Planning

  7. Grant Manager Job Responsibilities • Goal: Make sure we are “audit-ready” at all times • Create a grants management structure • Ensure organizational compliance with grantor terms and conditions • Establish policies and procedures, and standard operating procedures for grants management • Review all proposals and awards • Provide technical assistance and training • Maintain records of funding sources, grant applications and grant awards

  8. Grant Application Process Deadlines for Grant Applications • Intent to Apply • Notify ORA 30 days before grantor deadline • Complete Research Review Application • Application Review Meeting (if necessary) • Internal Deadline • 5 full business days before grantor deadline (equal to 6 working days) • First in, first out • Feedback communicated via email, conference call or meeting • Grantor Deadline

  9. Why the Deadlines? • TO WIN! • Increase Competitiveness • Ensure Compliance with Grantor Application Instructions and Terms of Agreement • Review and Approve Budget • Ensure Organizational and Departmental Compliance with Grantor Requirements • Legal Review (when necessary)

  10. Grant Application Process 1. Notify ORA of Intent to Apply 30 days before grantor deadline 2. Complete and Submit Research Review Application to ORA ORA/FH Legal Review of Application Documents 3. Application Review Meeting with Grant Manager, if Necessary 4. Meet Internal Deadline 6 days before Application is Due to Grantor 5. Grant Manager Provides Feedback to Department 6. Meet Grantor Deadline At Least One Day Before Deadline

  11. Award Review Process 1. Department Submits Award Documents to ORA 2. ORA Submits Award Documents to FH Legal FH Legal Review of Award Documents 3. Legal Provides Feedback/Approval to Grant Manager 4. Once Both Parties Agree on Award, Legal Obtains Signature from Lee Johnson, Vice President 5. ORA Staff Coordinate Other Signatures and Submit Executed Award to Grantor 6. Grant Manager Schedules Award Review Meeting with PI, Coordinators, Finance

  12. Coming Soon • The Foundation Center’s Foundation Directory Online • Available to Everyone • Training Class Date, TBA • Grant Planning Calendar • Award Planning Meetings • Technical Assistance (one-on-one or groups) • Training Workshops • Policies and Procedures, and Standard Operating Procedures

  13. Michelle Kilponen Operations Specialist • Bachelor of Science, Biological Sciences • Clemson University • Working with FH since 2001

  14. Amy HintonAdministrative Assistant • Bachelor’s of Arts – Cornell University • Worked at FH since 2002 • Radiology Transcription • Started at ORA September 2010 • ORA Mailbox • Assists with study processing

  15. ORA Operations Submission Process Research Review Application Budget Contracts InfoEd Access

  16. Standard Operating Procedures (SOP) Review Internal review by ORA Notify research departments Conference call to review and discuss ORA will review and revise Send out to research depts for final comments Finalize SOP

  17. Elena CrosbyParalegal • Contracts and Compliance Officer – Connextions, Inc. – Business process outsourcer in the healthcare industry • Director, Legal & Government Affairs and Ethics and Compliance Officer– Digital Fusion, Inc. - Department of Defense contractor. • Paralegal – PowerCerv Corporation – software applications company

  18. Legal Review • Contract review/negotiations • Letters of Agreement • Internal Approval Process • Grants review

  19. Nancy Barrett Research Accountant • Deposits • Equity Transfers • Payments

  20. Deposits • Send checks to Nancy Barrett attention at Accounting Dept., Medical Plaza, Suite 50 or FH Box 37. • Please write project/equity# on check. • Checks are deposited the same or next day. (credited against the accounts receivable.) • Receive check that’s not yours? Send to Accounting.

  21. Equity Transfers • Email to request transfer. • Transfer $ from equity to cc as revenue is earned/expenses are incurred (accrual basis). • Equity of terminated studies should $0 and close before year-end FH close. (revenue recognition.) • Equity should only contain sponsor prepayments. Earned revenue should be transferred to your cc research revenue.

  22. Payments • PAVs: • Pay from cc. Submit to FH accounts payable. ORA # should be listed on PAV. • New patient travel vendors, A/P will need name, address, social security # and telephone (fax also if available. • Other vendors need to complete IRS W-9 form and the FH 9 questions forms (if vendor is sole- proprietor). • IRB Fees: • Email to transfer payment to IRB. • Please include IRB # and ORA #, if different.

  23. Payments (continued) • Payments to employees • (patient travel stipends): Complete M4 form, submitted via email to Amanda Klawe in FH payroll. • Patient write-off NSC: • Working on process to transfer, rather than PAV. • Currently, please email the PFS research spreadsheet with payment amount per patient marked. I will send a PAV back for signature.

  24. Christina Jackson, BSN, RN, CCRCCompliance & Education Specialist • Registered Nurse for 20 years • Critical Care/Cardiology Background • Began research at FH in CV in 1994 • Research Management since 1998 • Hospital, academic, and private practice settings • Experienced Multiple Sponsor Audits, two FDA Audits, & an IRB Audit

  25. Research Education Current Classes Study Initiation 101 Informed Consent Protocol Development Budget Development InfoEd

  26. Expanding Educational Offerings Addition of New Classes Offer CME’s and/or CEU’s Exploring Different Formats Continue One-on-One Training Assist in Orienting Employees New to Research at FH Assistance with Protocol Implementation and Method of Data Collection

  27. Compliance Conduct On-site Reviews for the purpose of Compliance, Education, & Quality Improvement Ensure Compliance with GCP’s, Appropriate Regulatory Agencies, and FH SOP’s Assisting in the review and revision of current FH SOP’s Development of FH Source Docs, tools, templates, logs, and forms Assist in the Development of a Corrective Action Plan Post Compliance Review and/or Audit Assistance in Preparation for External Audits, such as FDA or DHHS

  28. Julie PepeBiostatistician • Bachelors degree in Biology • Quantitative Genetics, Purdue University • Associate Director, Institute of Statistics, University of Central Florida • Measurement and Data Mining, PhD • Statistical Consultant

  29. Consulting Experience Mennello Museum Disney’s Animal Kingdom Visiting Nurse Association Florida Game and Fresh Water Fish Commission, Alligator Management Unit United Arts of Central Florida Teach-In, OCPS Division of Community Affairs, State of Florida Edyth Bush, Charitable Organization Darden Restaurants Division of Juvenile Justice Florida Hospital U.S. Water-Ski Team Nature Conservancy Legal Aid Society Orange County Medical Examiner ORMC EPCOT Center, The Land Coca-Cola Foods Humana Health Care Rollins College EPCOT Center, Living Seas American States Insurance Orlando Police Department Institute of Simulation and Training (U.S. Army) Walt Disney University CRA Research Group Orange County Parks and Recreation Division Martin Marietta, Laser Division Mental Health Services of Central Florida National Aerospace Inc. JROTC Bishop Moore High School Seminole County Planning Department Florida Audubon Society Orange County Court System American Statistical Association

  30. Statistical Assistance Support is focused on the following areas of service: • Preliminary Study Design – • Statistical design including variable selection • Sample size • Power analysis • Advanced Study Design – • Review of protocol statistical analysis section • Advice regarding appropriate analytic tests • Case report forms or electronic collection • Study Implementation – • Assistance with surveys • Assistance with developing a data table for data entry • Study Completion– • Assistance with statistical analysis • Review of analysis and interpretation of results • Review of written statistical interpretation section of paper

  31. Procedure Once your project objective is sufficiently focused: • Obtain a study number by completing an Research Review Application (RRA) form available on the ORA website • Statistical assistance needs to start immediately after the ORA number is assigned. PI’s should understand that ORA may reserve the right to refuse services initiated at a later point in time. • Take advantage of the statistical expertise provided by ORA in order to minimize problems at the analysis phase of the study. • Problems with publications can be avoided with proper planning!

  32. Statistical Expectations • Depending on if you are just starting a study, getting prepared to collect information, entering data, analyzing data or interpreting output, you will be asked questions regarding the study protocol and objectives. • In order for me to give you accurate information, I need to understand the big picture and most of the details – this takes time. • Please plan on contacting ORA at least allow one to three weeks prior to any deadlines in order to adequately assist with any statistical issues. • If you are applying for a grant, protocol review should happen at least one week prior to ORA deadlines (which are five working days prior to grant deadlines)

  33. 2011 Statistical Enhancements • Goal: To increase the quality of research at Florida Hospital • Result: Increase the quality of publications from our researchers • Consulting request form • Classes or workshops • Collaboration between Grants, Education and Statistical support • Contact information Julie.Pepe@flhosp(407) 303-7756 Ext. 110-8414

  34. Changes for 2011 • IRB Net • AAHRPP • Conflict of Interest • Research Town Halls • ORA & IRB combined meetings • Expansion of Education • Clinical Trials Management software • Data Mining • Change, change, change • Better Communication • Our team to yours • You to us

  35. questions comments

More Related