Office of Clinical Research and the. Institute (CTSI) Patricia Emmanuel, MD

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1 Office of Clinical Research and the Clinical and Translational Research Institute (CTSI) Patricia Emmanuel, MD

2 Office of Clinical Research- Priorities Review processes for clinical study implementation, develop tracking system, policies, streamline services Revise the clinical trial internal form and review. Implement budget assistance and central procurement of services through the office of research. Purchase and implement study management software. Improve p interface and communication with clinical operations Coverage review and feasibility analysis Develop investigational pharmacy services and clinical Develop investigational pharmacy services and clinical research center on campus

3 History of CTSA Awards In 2005, the NIH National Center for Research Resources (NCRR) implemented the Clinical and Translational Science Awards (CTSAs) program In 2006 USF received a planning grant to help prepare for the application to join the consortium 24 academic health centers, located throughout the nation, are part of the consortium In 2012 approximately 60 institutions will be linked to energize clinical and translational research NIH CTSA Program Goal The CTSA institutions must develop institutes, centers or departments with innovative i approaches to build academic homes for clinical i l and translational l science.

4 NIH CTSA Awards Clinical i l Research Ethics Trial Design Biomedical Informatics Clinical Resources CTSA HOME Advanced Degree-Granting Programs Participant & Community Involvement Biostatistics Regulatory Support NIH, 2006

5 Key Functions and Components of an Institutional CTSA Biomedical Informatics Novel Clinical and Translational Methodologies Pilot/collaborative studies/signature programs Research Design, Epidemiology and Biostatistics Regulatory Knowledge and Support Clinical resources and institutional agreements Translational Technologies and Resources Research Education and Training Community Engagement Evaluation

6 USF CTSI-Purpose The CTSI will facilitate clinical and translational research at USF through integration and enhancement of services and by supporting a collaborative environment for investigators. The CTSI will form the framework of the CTSA application In 2009.

7 CTSI Components Education and Training Develop research training courses and opportunities for investigators. On-line Clinical research methods course, Protocol templates and other resources on website Assist investigators t in identifying i and obtaining i training grants Support the K30 scholars program and promising young investigators through release time Enhance coordinator training and support Work with DSR to improve training to departmental and research administrators at the COM.

8 CTSI Components- Clinical Research Services Improve the flow of human subject clinical trials and make the process more transparent to the investigator Develop coverage analysis and feasibility review Offer additional services such as budget development and central procurement of research services Develop a Scientific Oversight Committee to assist in scientific reviews and protocol development particularly for investigator initiated research Develop Investigational Pharmacy services on campus by October 08. Develop a Clinical Research Center at medical clinics by January 09.

9 CTSI Components- Biostats/Informatics/Outcomes Provide biostatistical support to investigators Develop a health informatics initiative and platform Make available data management support to investigators Enhance research and training in the area of evidence Enhance research and training in the area of evidence based medicine, and health care quality and outcomes

10 Future Components and Initiatives: Strong integration with regulatory support services to provide enhanced assistance in regulatory affairs for faculty particularly in the areas of new drug development Novel translational technologies and methods, enhancing core facilities and services around translational research Community engagement to include facilitating community based research, institutional agreements and initiatives

11 Next Steps: Recruit itfaculty and champions of various components to include faculty from both USF Health and main campus Establish working committees of CTSI Retreat and timeline for grant development Continueto lobbyfor additionalinstitutionalsupport Continue to lobby for additional institutional support necessary to submit a competitive application