TGH Office of Clinical Research: Reorganization and Restructuring

Transcription

1 TGH Office of Clinical Research: Reorganization and Restructuring Medical Directors Meeting Tampa General Hospital November 30, 2006 Abdul S. Rao, MD, MA, DPhil Medical Director - Clinical Research Tampa General Hospital

2 Organizational Structure: Institute for Translational & Clinical USF Health Sr. Associate Vice President (Abdul S. Rao) Office of Clinical TGH Director (Patti Simmons, PhD) Other Potential Affiliate Sites Office of Clinical Research (For USF Faculty ONLY) Pre-Award Biostatistics* Post-Award Education* Pre-IRB Review Protocols Marketing* Information technology* Database Development & Management *services offered to both USF and non-usf faculty

3 Organizational Structure: Office of Clinical TGH President and CEO - TGH (Mr. Ron Hytoff) Medical Director (Abdul S. Rao, MD, MA, DPhil) Director (Patti Simmons, PhD) CORE Clinical Research Nurse Denise Fife Clinical Research Nurse Jessica Wojcik Research Pharmacy Pharmacist Shacreyett Burton Pharmacy Technician Administrative Assistant Heather Portwood Research Finance Specialist Vivian White Research Finanace Specialist Mike Nikolau Research Compliance Analyst Gene Gunn Research Manager Lori Banctel Project Coordinator Hayley Carr Project Coordinator

4 Office of Clinical Research I Coordinates with other departments at TGH and USF to carry out essential institutional functions of research related to: Federalwide Assurance (FWA/OHRP) Intellectual Property Risk Management Nursing Research HIPAA Quality Assurance Credentialing/Training/Education Legal/Contracts Patient Care Budgeting review of both sponsor and hospital budgets Contract Review indemnification, subject injury, reimbursement Billing/Collections research fee schedule, receivables management, financial metrics Protocol Implementation evaluation of resources required, coordination of clinical effort Investigator Assistance medical writing, biostatistics, education and inservicing Compliance Activities HIPAA, billing. OHRP, etc.

5 Office of Clinical Research II Facilitate clinical research activity at TGH by educating colleagues and peers from both USF and the community on the conduct of research and other relevant information Physicians Nurses Practitioners Residents (Pharmacy and Medicine) Students (COE, COPH, COM, CON, etc.) Assist investigators and sponsors in the: writing, design, submission and review of protocols development and negotiation of appropriate budgets review of contracts/clinical trial agreements/site agreements and master agreements Assist Research Committee and all of its Subcommittees in the review and approval of clinical research protocols Provide operational and administrative oversight to the Center for Outpatient Research Excellence (CORE) Regulatory Work Research Nurses/Coordinators Budget and Contract Review/Negotiation Treatment Room

6 Research Committee Mission: Review and approve clinical research protocols for conduct at TGH that are scientifically and clinically meritorious, ethically sound, advantageous to patients, and appropriately minimize risks 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 to cutting-edge diagnostic and therapeutic modalities along with extensive research resources, all of which ultimately advance our understanding of human diseases and behaviors

7 Research Committee Responsibilities The primary responsibilities of the Research Committee are: Ethical Review Evaluation of Scientific/Clinical & Medical Merit/Justification Assessment of Study Design and Methodology Financial Feasibility Institutional/Site Resources & Requirements Operational Issues

8 Research Committee Meetings 2007 Packets for committee member review will be distributed electronically and in hardcopy format one week before the meeting One meeting will be held each month on the fourth Thursday of the month at 7a.m. All studies that have been successfully reviewed by the Feasibility Subcommittee by the first Thursday of the month will be presented for review to the Research Committee

9 Retrospective and Exempt Protocols Retrospective and Prospective studies in the exempt status traditionally do not involve any institutional resources Office of Clinical Research Research Committee

10

11 Feasibility Subcommittee - Membership Abdul S. Rao Patti Simmons Lori Banctel Rogers Howard Maureen Ogden/Leah Godfrey Anthony Escobio/Loren Dyer Shacreyett Burton Dale Knight Ray Widen Brenda Junco Dina Fanti

12 Feasibility Subcommittee 2006 and 2007 Meetings Meetings for 2007 will typically occur on the first and third Thursdays of the month from 11 a.m. to 12 p.m. Meetings scheduled for the remainder of 2006 include: Friday, December 8, a.m. G-603

13

14 Emergency Use Subcommittee - Membership Abdul S. Rao Elamin Elamin Maureen Ogden Wayne Maberry Mary Kutash Rogers Howard Anthony Escobio Lori Banctel Shacreyett Burton Gene Gunn David Shapiro Dale Knight

15 Emergency Use Subcommittee - Meetings This subcommittee will not require in-person meetings Due to the time-sensitive nature of these requests, it is expected that this process will largely take place electronically with the request approved or otherwise within 24 hours of its submission

16 TGH Office of Clinical Research: Personnel Director Patti Simmons Manager Lori Banctel Compliance Analyst Gene Gunn Finance Specialist Vivian White Finance Specialist Mike Nikolau Project Coordinator Hayley Carr Project Coordinator TBD Research Nurse Denise Fife Research Nurse Jessica Wojcik

17 TGH Office of Clinical Research: Contact Information CEDAR Building E

18 TGH Office of Clinical Research: CORE Center for Outpatient Research Excellence Harbourside Medical Tower Suite