TGH Office of Clinical Research: Strategic Planning Retreat

Simmons – Houston – Rao - Feb 22, 2007

http://research.health.usf.edu/tghocr/index.html

Opening Remarks

� Ron Hytoff

� Dr. Rao

USF Institute of Clinical and Translational Research

� Discussion Leader—Dr. Houston

USF Institute of Clinical and Translational Research

� Dr. Sally Houston

� http://research.health.usf.edu/ictr/index.html

� CTSA Planning Grant

� Role of ICTR

� Staff of ICTR

� How ICTR will work with TGH OCR

USF Institute of Clinical and Translational Research

� Role of ICTR� Mission

� To enhance clinical and translational research at USF Health, its affiliate partners, and in the Greater Tampa Bay area with the ultimate objective of engaging physicians, students, residents and fellows in the delivery of cutting-edge patient care.

Vision� Vision

� Physicians, students, residents and fellows at USF Health and its affiliate partners will be involved in investigator-initiated and extramurally funded clinical and translational research which ultimately advances our understanding of human diseases and behaviors.

� Values

� With cutting-edge discovery and innovation, provide state-of-the-art:

� treatment and treatment options for our patients

� education and training of our students and residents

� We also value life-long learning and the recruitment and retention of the most qualified academic physicians and health care providers.

USF Institute of Clinical and Translational Research

TGH Office of Clinical ResearchDirector

(Patti Simmons, PhD)

Other Potential Affiliate Sites

Pre-Award Biostatistics*

ICTRAssociate Dean

(Sally H. Houston, MD)

Sr. Associate Vice President(Abdul S. Rao, MD)

Pre-Award Biostatistics*

Post-Award Education*

Pre-IRB ReviewProtocols

Marketing*

Information technology*Database Development

& Management

*services offered to both USF and non-USF faculty

USF Institute of Clinical and Translational Research

� ICTR will work with TGH

�Joint Retreat for strategic planning and

process integration (pre-award, IRB, process integration (pre-award, IRB,

post-award, compliance, etc.)

�Biostatistical Support for investigators

�Consider joint recruitment

TGH Office of Clinical Research

� Discussion Leader—Patti Simmons, PhD

TGH Office of Clinical Research

Director(Patti Simmons, PhD)

813-844-4236

Medical Director(Abdul S. Rao, MD, MA, DPhil)

USF 813-974-5200TGH 813-844-7831

President & CEO - TGH(Mr. Ron Hytoff)

Clinical Research NurseDenise Fife

813-844-7829

Clinical Research NurseJessica Wojcik813-844-4639

Center for Outpatient Research Excellence(CORE)

Administrative AssistantHeather Portwood

813-844-7989

Research Financial SpecialistMichelle Ayala813-844-4162

Senior Research Financial SpecialistMike Nikolau813-844-8189

Research Compliance AnalystGene Gunn

813-844-8135

Project CoordinatorHayley Carr

813-844-8113

Project CoordinatorBeth Keschman813-844-7482

Research ManagerLori Banctel

813-844-4898

What We Do: Office of Clinical Research

� Coordinates with other departments at TGH and USF to carry out essential institutional functions of research related to:

� Protocol Implementation—evaluation of resources required, coordination of clinical effort

� Investigator Assistance—medical writing, biostatistics, budgeting, education and inservicingand inservicing

� Nursing Research

� Budgeting—review of both sponsor and hospital budgets

� Contract Review—indemnification, subject injury, reimbursement

� Billing/Collections—research fee schedule, receivables management, financial metrics

� Credentialing/Training/Education

� Federalwide Assurance (FWA/OHRP)

� Quality Assurance & Compliance Activities—HIPAA, billing. OHRP, etc.

TGH OCR: Progress Toward Objectives

TGH OCR: Objective 1-Staffing

� TGH OCR has been completely staffed.

Seven new positions were created and filled

to support financial, protocol, management to support financial, protocol, management

and compliance functions.

TGH OCR: Objective 2-Infrastructure Development

� TGH OCR has created the infrastructure for

protocol review and approval at the hospital. This

involves a fully operational Research Committee involves a fully operational Research Committee

comprised of physicians, nurses, and leaders of

other departments throughout the hospital charged

with reviewing all prospective studies.

� The Research Committee (RC) meets once a month

and now utilizes a primary reviewer system.

Research Committee Mission & Vision

� Mission:� Review and approve clinical research protocols for conduct at

TGH that are scientifically and clinically meritorious, ethicallysound, advantageous to patients, and appropriately minimize riskswhile maximizing potential benefits to the patients, physicians,while maximizing potential benefits to the patients, physicians,and the institution

� Vision:� To continue enhancing and fostering the research environment at

TGH while providing physicians and patients with access tocutting-edge diagnostic and therapeutic modalities along withextensive research resources, all of which ultimately advance ourunderstanding of human diseases and behaviors

Research Committee Responsibilities

� Review protocols according to the following

criteria:� Ethical� Ethical

� Scientific/Clinical & Medical Merit/Justification

� Study Design and Methodology

� Patient Safety

TGH OCR: Feasibility Subcommittee

� Along with the RC, there are now several

subcommittees designed to fulfill specific

functions associated with research. These functions associated with research. These

are:

� Feasibility Subcommittee

� Emergency Use Subcommittee

� Investigational Pharmacy Subcommittee

Feasibility Subcommittee Scope

� The Feasibility Subcommittee (FC) meets

twice monthly to review protocols based on

their:their:� Financial Feasibility

� Institutional/Site Resources & Requirements

� Operational Issues

� Other….

TGH OCR: Objective 3-Financial Management

� Billing Database

� PFS Workgroup (parent and sibling accounts)

CDM Maintenance/Pricing Models� CDM Maintenance/Pricing Models

� Successful Collections ($103,423)

� Sponsor Budget Negotiation

� TGH Budget and P&L Evaluations

TGH OCR: Objective 4-Education

� Coordinator Education

� Monthly Meetings with all Research

Coordinators to discuss issues of importance to Coordinators to discuss issues of importance to

them and provide education.

� Attendance is now tied to the Credentialing

process at TGH.

TGH OCR: Objective 5-CRC/CORE Restructuring

� CORE—Center for Outpatient Research Excellence

� Closed and/or Transferred 22 CRC Studies

Retrospective Chart Reviews� Retrospective Chart Reviews

� Bowers Bellatacept Study

� Elamin Precedex Study

� Cancio/Bernasek Cubicin Study

� Houston/Montero ID Studies

TGH OCR: Objective 6-Service Orientation

� OCR Services� Medical Writing for Investigators (protocols, abstracts, manuscripts, grant proposals),

Biostatistical Support, and Budget/Contract Negotiations� Anesthesiology

� Transplant

� Nursing� Nursing

� Pharmacy

� Surgery

� Infectious Disease

� Cardiology

� Emergency Medicine

� Vascular Surgery

� Neonatology/Pediatrics

� OB/GYN

� Pulmonary/Critical Care

� Orthopedics

TGH OCR: Objective 7-Website

Research Cost Segregation

� Discussion Leader—Dr. Rao

Research Cost Segregation

� There has been considerable discussion of the need to segregate research expenditures and revenue for the institution.

� This would involve identifying our current and � This would involve identifying our current and potential future expenditures and creating a single cost center for these.

� Further, it would require all research revenue to be captured as such and a mechanism to clearly distinguish research revenue from patient revenue or other revenue.

Research Cost Segregation

� Research Expenditures

� Purchased Devices/Drugs for studies� What amount will be allotted each year?

� Currently our purchases are not aggregated in a single cost center and are difficult to identify as research purchases as they become indistinguishable from other purchases in these cost centers (pharmacy, surgical services, etc.)identify as research purchases as they become indistinguishable from other purchases in these cost centers (pharmacy, surgical services, etc.)

� How can we differentiate research inventory from stock? (MMIS) Can this flow through to a case/use of such inventory such that our record keeping would reflect this?

� FTEs� Currently, FTEs reside outside the 18346 and 19803 cost centers who have primary

research responsibilities.

� Operating Costs for OCR and CORE cost centers� This would include personnel, capital purchases, equipment, supplies, utilities,

postage, etc.

Research Cost Segregation

� Research Revenues

� TGH Awarded Studies & Some Grants� These type studies are currently awarded to the institution and a GL account is

created for each. The total award includes amounts for OCR costs, nursing time, etc. but not all of this is currently captured as research revenue nor are expenditures charged to these grants necessarily captured as research.charged to these grants necessarily captured as research.

� CORE Services� Studies where Research Nursing services are provided via the CORE are billed to the

investigator and generate revenue.

� Pharmacy Set-Up, Lab/Radiology/ and Other Set-Up Fees

� Nursing Time or Other Time Spent on Research

� OCR Administrative Fees� Work of OCR to start-up studies, build budgets, negotiate contracts, submit LCD

requests, etc. (CDMs have been established to capture these costs)

� Indirects on all TGH budget items (15%)

Awareness and Communication

� Discussion Leader—Patti Simmons, PhD

Awareness and Communication

� Internal Awareness of Research

� Knowledge of Department Practices and Processes within the Hospital� Leadership

� Research Committee Members,

� Patient Services Executive,

� Nurse Practice Forum,

� Patient Safety Committee,

� HIM/Coders� HIM/Coders

� Pre-Certification/Pre-Admissions

� Admissions

� Incorporating Research in Annual Update, Educational Opportunities for Nurses (Human Subjects Education, ACRP Certification, etc.)—Opportunities for CEDAR to assist

� Education Standards for Approved Studies

� Who needs to be educated?

� How will they become educated?

� Who will provide education?

� Awareness and Notification of Research Subjects

� Differences Between Research and QI/QA Initiatives

� Identifying Nursing Research Opportunities for Nursing Staff

� Making Information about Studies Available on Secured Research Portal

Awareness and Communication

� External Awareness of Research

� Knowledge and Awareness of Department Staff, Procedures, Location

� Physician Understanding of Processes, Categories of � Physician Understanding of Processes, Categories of Research, and Committees

� Coordinator Orientation and Credentialing

� IRB Understanding of TGH Processes

� Addressing Non-Compliance

� Ensuring Vendors Understand TGH and IRB Processes

Educational Opportunities and Needs

� Discussion Leader—Dr. Houston

Educational Opportunities and Needs

� Education of TGH staff on approved studies for all those nursing and other staff affected by protocols. � What are the standards?

� How best to accomplish?How best to accomplish?

� Coordinator Orientation and Credentialing.� Formal Orientation required

� Annual Credentialing

� Involvement of Human Resources/Medical Staff Services

� Policy is currently under revision

� Will be tied to attendance at Monthly TGH OCR Coordinator Meetings

Educational Opportunities and Needs

� Method of Identifying Patients/Subjects Participating in Research at TGH� Consistent

� AutomatedAutomated

� Integrated from Clinical, Financial, HIM, and other applications

� Biostatistical Support� Physicians

� Nursing Research

Educational Opportunities and Needs

� Data Requests related to research should be submitted to OCR for proper approval and record keeping. This includes:� Aggregate site level data on admissions, discharges, etc.Aggregate site level data on admissions, discharges, etc.

� Medication use

� Medical record review

� Specimen review

� Radiology review

� Requests to export/upload data to other sites or parties for research use involves disclosure and should involve the OCR (Matar, Quintero, Saneron)

Educational Opportunities and Needs

� Automated Study Management Software to integrate record keeping for:� Financial (budget and billing)

� Regulatory review/IRBRegulatory review/IRB

� Patient Enrollment and Visits

� UDS/Study Manager options have been considered

� Research Portal for use by employees and researchers:� Role based access

� List of all approved studies

� Online education

� Data sheets, forms, meeting dates, etc.