Julie Pepe, Biostatistician

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
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
1. Department Submits Award
Documents to ORA
2. ORA Submits Award Documents
to FH Legal
FH Legal Review of Award
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 soleproprietor).
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
Disney’s Animal Kingdom
Visiting Nurse Association
Florida Game and Fresh
Water Fish Commission,
Alligator Management Unit
United Arts of Central
Teach-In, OCPS
Division of Community
Affairs, State of Florida
Edyth Bush, Charitable
Darden Restaurants
Division of Juvenile Justice
Florida Hospital
U.S. Water-Ski Team
Nature Conservancy
Legal Aid Society
Orange County Medical
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
Mental Health Services of
Central Florida
National Aerospace Inc.
Bishop Moore High School
Seminole County Planning
Florida Audubon Society
Orange County Court System
American Statistical
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 [email protected] (407) 303-7756 Ext.
 IRB Net
 Clinical Trials
Management software
 Conflict of Interest
 Data Mining
 Research Town Halls
 Change, change, change
 ORA & IRB combined
 Expansion of
 Better Communication
 Our team to yours
 You to us

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