Supporting Clinical Research

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Supporting Clinical Research AAAS/Science Translational Medicine Panel Library-based Support for Translational Medicine Jennifer A. Lyon, MS, MLIS, AHIP Clinical Research Librarian UF Health Science Center Libraries jalyon@ufl.edu May 16, 2011

Founded in 2008 Provides over 40 services to UF&Shands researchers Phase I Clinical Trial Unit Clinical Research Center Core Laboratory Services Project Navigators (consultant services) Provides various educational programs KL2 and TL1 awards Research Coordinator Certificate Program MD-PhD Training MSCI

The Clinical Research Librarian Library competed for funding UF Provost re-designated position for CTSI support Hired July 23, 2010 Liaison to CTSI Emergency Medicine Pathology, Immunology & Laboratory Medicine Functions as cross-disciplinary expert in clinical research

Developing a New Role: Challenges No role models Complexity of clinical research High learning curve Multiple Agencies and Regulations Unique to each institution New vocabulary (IRB, RAC, IND, DSR, RKRS ) Complex web of relationships to develop

Developing a New Role: Opportunities CTSI members involved in hiring committee UF highly invested in clinical & translational research Other librarian-involved research collaborations in development Library expanding clinical services & support for Evidence-Based Practice Significant need for a librarian specializing in supporting clinical researchers

CTSI Integration Serve in CTSI Regulatory Knowledge & Research Support (RKRS) Group Collaborate with RKRS members on studies/grants CTSI requested library instruction in academic course CTSI added literature searching services to RKRS portal Participation in CTSI Strategic Planning Retreat and Workgroups Working with CTSI to track & improve inclusion of CTSI in investigator publications Representing UF on national CTSA Research Networking Committee Representing UF on national REDLOC committee

About the RKRS CTSI Regulatory Knowledge & Research Support program Develop a guided, single pathway for clinical investigators to move from idea to completed clinical study Clinical Research Center Institutional Review Board Research Administration & Compliance Dept. of Sponsored Research Office of Technology Licensing Dental Research Unit REDCap Data Capture/Management Quality Assurance Research Subject Advocacy Biostatistics BioRepository Health Science Center Library

Research Ethics Project RKRS-facilitated Research Team Focus: Conflict of Interest in UF College of Medicine Team Members: UF COM s Conflict of Interest Officer RKRS program director REDCap services director/biostatistician Health and Science Communications doctoral student CTSI research project manager Clinical Research Librarian Manuscript in submission process

Teaching Instructor in the CTSI s credit-bearing course Introduction to Clinical and Translational Research (summer 2010, 2011) Taught literature searching skills to CTSI MD-PhD students fall 2010

Research Networking Representing UF on the CTSA s national Research Networking Committee Participating on the VIVO Outreach Team at UF

CTSI Strategic Planning Invited with Director to attend the CTSI s annual strategic planning retreat Serving on the CTSI s Strategy Development Workgroup Working with RKRS members to develop standardized procedures for UF clinical researchers

Beyond the CTSI Emergency Medicine Brain Cancer Patient/Caregiver Education NIH Public Access Policy Services Support for Systematic Reviews In-house Training for Librarians

Future Goals Continue to develop CTSI integration and collaboration Increase support for investigators writing IRB protocols Develop further opportunities for clinical research partnerships Assist library colleagues with evidence-based practice, clinical research, & community health projects Support and develop point-of-care clinical librarianship services and leverage on these to increase involvement in clinical research