Julie Pepe_ Biostatistician

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Julie Pepe_ Biostatistician Powered By Docstoc
					December 7, 2010
Changes at the ORA
 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
 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.)
 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
 Goal: Make sure we are “audit-ready” at all times
 Create a grants management structure
   Ensure organizational compliance with grantor terms and
     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
Deadlines for Grant Applications
   Intent to Apply
    1. Notify ORA 30 days before grantor deadline
    2. Complete Research Review Application
    3. 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
   Grantor Deadline
 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)
1. Notify ORA of Intent to Apply 30
days before grantor deadline

        2. Complete and Submit Research              ORA/FH Legal Review of
        Review Application to ORA                    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
1. Department Submits Award
Documents to ORA

    2. ORA Submits Award Documents               FH Legal Review of Award
    to FH Legal                                  Documents

        3. Legal Provides Feedback/Approval to
        Grant Manager

                4. Once Both Parties Agree on Award, Legal
                Obtains Signature from Lee Johnson, Vice

                              5. ORA Staff Coordinate Other Signatures
                              and Submit Executed Award to Grantor

                                         6. Grant Manager Schedules Award Review
                                         Meeting with PI, Coordinators, Finance
 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
 Bachelor of Science, Biological Sciences
 Clemson University
 Working with FH since 2001
 Bachelor’s of Arts – Cornell University
 Worked at FH since 2002
   Radiology Transcription
 Started at ORA September 2010
   ORA Mailbox
   Assists with study processing
Submission Process
 Research Review Application
 Budget
 Contracts

 Access
• 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
Contracts and Compliance Officer – Connextions, Inc.
– Business process outsourcer in the healthcare
Director, Legal & Government Affairs and Ethics and
Compliance Officer– Digital Fusion, Inc. - Department
of Defense contractor.
Paralegal – PowerCerv Corporation – software
applications company
 Contract review/negotiations
 Letters of Agreement
 Internal Approval Process
 Grants review
 Deposits
 Equity Transfers
 Payments
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
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
Equity should only contain sponsor
prepayments. Earned revenue should be
transferred to your cc research revenue.
  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
  Other vendors need to complete IRS W-9 form and
  the FH 9 questions forms (if vendor is sole-
IRB Fees:
  Email to transfer payment to IRB.
  Please include IRB # and ORA #, if different.
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.
 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
 Experienced Multiple Sponsor Audits, two FDA
Audits, & an IRB Audit
 Current Classes
 Study Initiation 101
  Informed Consent
Protocol Development
Budget Development
 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
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
 Bachelors degree in Biology
 Quantitative Genetics, Purdue University
 Associate Director, Institute of Statistics,
 University of Central Florida
 Measurement and Data Mining, PhD
 Statistical Consultant
Mennello Museum                Nature Conservancy            Recreation Division
Disney’s Animal Kingdom        Legal Aid Society             Martin Marietta, Laser
Visiting Nurse Association     Orange County Medical         Division
Florida Game and Fresh         Examiner                      Mental Health Services of
Water Fish Commission,         ORMC                          Central Florida
Alligator Management Unit      EPCOT Center, The Land        National Aerospace Inc.
United Arts of Central         Coca-Cola Foods               JROTC
Florida                        Humana Health Care            Bishop Moore High School
Teach-In, OCPS                 Rollins College               Seminole County Planning
Division of Community          EPCOT Center, Living Seas     Department
Affairs, State of Florida      American States Insurance     Florida Audubon Society
Edyth Bush, Charitable         Orlando Police Department     Orange County Court System
Organization                   Institute of Simulation and   American Statistical
Darden Restaurants             Training (U.S. Army)          Association
Division of Juvenile Justice   Walt Disney University
Florida Hospital               CRA Research Group
U.S. Water-Ski Team            Orange County Parks and
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
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
• 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
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)
•Goal: To increase the quality of research at Florida
•Result: Increase the quality of publications from our

•Consulting request form
•Classes or workshops
•Collaboration between Grants, Education and Statistical
•Contact information Julie.Pepe@flhosp (407) 303-7756 Ext.
 IRB Net                 Clinical Trials
 AAHRPP                   Management software
 Conflict of Interest    Data Mining
 Research Town Halls     Change, change, change
   ORA & IRB combined    Better Communication
    meetings                Our team to yours
 Expansion of              You to us
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