Office of Research Administration

Update

December 7, 2010

Changes at the ORA

ORA 2010 ChangesAccommodate expected growth of research at FH

Greater collaboration with external entitiesUCF, Sanford-Burnham, etc.

Investigator initiated studiesStudy Support

BiostatisticalCompliance & Education

Expansion of grant-seeking

ORA 2010 ChangesMaintain pace with current research marketplace

Speed of study start-upTime for legal review of contracts

Conflict of InterestDebarment

Correct historical problemsLack of infrastructure to support grantsP&Ps (timely review, updating, etc.)www.youtube.com/watch?v=m-KFTXIoQvY

where documents go in, but may never come out…

Donna GoraGrants Manager

EducationMasters in Administrative Science (Nonprofit Management)Bachelors in FinanceCertificate in Federal Grants Management

BackgroundGrants ManagementTraining and Technical AssistanceOutcomes Based EvaluationTechnical WritingMarketing CommunicationsStrategic Planning

Grant Manager Job Responsibilities

Goal: Make sure we are “audit-ready” at all timesCreate 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 awardsProvide technical assistance and trainingMaintain records of funding sources, grant applications and

grant awards

Grant Application ProcessDeadlines for Grant Applications

Intent to Apply1. Notify ORA 30 days before grantor deadline2. Complete Research Review Application3. Application Review Meeting (if necessary)

Internal Deadline5 full business days before grantor deadline (equal to 6

working days)First in, first outFeedback communicated via email, conference call or

meeting Grantor Deadline

Why the Deadlines?TO WIN!Increase CompetitivenessEnsure Compliance with Grantor Application

Instructions and Terms of Agreement Review and Approve BudgetEnsure Organizational and Departmental

Compliance with Grantor RequirementsLegal Review (when necessary)

Grant Application Process1. Notify ORA of Intent to Apply 30 days before grantor deadline

2. Complete and Submit Research Review Application to ORA

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

ORA/FH Legal Review of Application Documents

Award Review Process1. Department Submits Award Documents to ORA

2. ORA Submits Award Documents to FH Legal

3. Legal Provides Feedback/Approval to Grant Manager

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

6. Grant Manager Schedules Award Review Meeting with PI, Coordinators, Finance

FH Legal Review of Award Documents

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

Coming SoonThe Foundation Center’s Foundation Directory Online

Available to EveryoneTraining Class Date, TBA

Grant Planning CalendarAward Planning Meetings Technical Assistance (one-on-one or groups)Training WorkshopsPolicies and Procedures, and Standard Operating

Procedures

Michelle Kilponen Operations Specialist

Bachelor of Science, Biological Sciences

Clemson University

Working with FH since 2001

Amy HintonAdministrative Assistant

Bachelor’s of Arts – Cornell UniversityWorked at FH since 2002

Radiology TranscriptionStarted at ORA September 2010

ORA MailboxAssists with study processing

ORA Operations

Submission Process Research Review Application

Budget Contracts

InfoEd Access

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

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

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

Nancy Barrett Research Accountant

DepositsEquity TransfersPayments

DepositsSend 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.

Equity TransfersEmail 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.

PaymentsPAVs:

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.

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.

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

Research Education

Current ClassesStudy Initiation 101Informed Consent

Protocol DevelopmentBudget Development

InfoEd

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

ComplianceConduct On-site Reviews for the purpose of Compliance,

Education, & Quality ImprovementEnsure Compliance with GCP’s, Appropriate Regulatory

Agencies, and FH SOP’sAssisting in the review and revision of current FH SOP’sDevelopment of FH Source Docs, tools, templates, logs,

and forms Assist in the Development of a Corrective Action Plan Post

Compliance Review and/or AuditAssistance in Preparation for External Audits, such as FDA

or DHHS

Julie PepeBiostatistician

Bachelors degree in BiologyQuantitative Genetics, Purdue UniversityAssociate Director, Institute of Statistics,

University of Central FloridaMeasurement and Data Mining, PhDStatistical Consultant

Consulting ExperienceMennello MuseumDisney’s Animal KingdomVisiting Nurse AssociationFlorida Game and Fresh Water Fish Commission, Alligator Management Unit United Arts of Central FloridaTeach-In, OCPSDivision of Community Affairs, State of FloridaEdyth Bush, Charitable Organization Darden RestaurantsDivision of Juvenile JusticeFlorida HospitalU.S. Water-Ski TeamNature Conservancy

Legal Aid SocietyOrange County Medical ExaminerORMCEPCOT Center, The LandCoca-Cola FoodsHumana Health CareRollins CollegeEPCOT Center, Living SeasAmerican States InsuranceOrlando Police DepartmentInstitute of Simulation and Training (U.S. Army)Walt Disney UniversityCRA Research GroupOrange County Parks and Recreation DivisionMartin Marietta, Laser

DivisionMental Health Services of Central FloridaNational Aerospace Inc.JROTCBishop Moore High SchoolSeminole County Planning DepartmentFlorida Audubon SocietyOrange County Court SystemAmerican Statistical Association

Statistical AssistanceSupport 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

ProcedureOnce 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!

Statistical ExpectationsDepending 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)

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

Changes for 2011IRB NetAAHRPPConflict of InterestResearch Town Halls

ORA & IRB combined meetings

Expansion of Education

Clinical Trials Management software

Data MiningChange, change, changeBetter Communication

Our team to yoursYou to us

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