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Enhancing Research and Regulatory Support Services Through Collaborative Innovation

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This initiative involves collaboration among key participants from Mayo Clinic and Yale to improve research and regulatory support services. Its objectives include sharing best practices, assessing feasibility, and developing collaboration models that minimize barriers faced by CTSA faculty. The project aims to increase efficiency in regulatory reporting and achieve cost savings. Key activities include centralized coordination for FDA audits, study file management support, and exploration of IT solutions for tracking and reporting. Lessons learned will guide future collaborations within the CTSA consortium.

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Enhancing Research and Regulatory Support Services Through Collaborative Innovation

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  1. Research/Regulatory Support Services Workgroup participants: Karen Hartman, Operations Manager, Office of Research Regulatory Support Cheryl Nelson, Associate Director - Administration, Mayo Clinic Center for Translational Science Activities (CTSA); Administrator, Research Operations Stacey Scirocco, Associate Director YCCI, Operations manager, Office of Research Services Theresa Katz, Coordinator, Office of Research Services, YCCI Administration Ad Hoc Members: Michael Lin, IT Unit Head, CTSA Informatics Joe Wick, Sr Analyst/Programmer, CTSA Informatics Robert Pawluk, Sr Analyst/Programmer, CTSA Informatics Thomas Johnson, Information Services Technical Specialist, CTSA Informatics Charles Lu, Assoc Dir Technology & Systems Dev, Ctr for Medical Informatics Frederic De Pourcq, Assistant Director, YCCI Tracy Yale, Evaluation, YCCI

  2. Research/Regulatory Support Services Purpose/Objectives: Identify opportunities to share practices for improvement of each others’ research/regulatory support services Evaluate and assess for feasibility; Develop implementation strategy and EXECUTE Development of collaboration model(s) and lessons learned for dissemination to the CTSA consortium

  3. Research/Regulatory Support Services Projected Impact: Increased support/services for CTSA faculty with barriers minimized Increased support to regulatory/reporting burden Achievement of overall cost savings through sharing of practices/services/support models CTSA consort. learning from our experiences (collaboration model, lessons learned, and IT transfer experience)

  4. Sub-project A: Centralized Coordination for FDA audits • Mayo resources: Tools, checklists and process flow for support during FDA audits • Mayo knowledge shared to Yale • Yale Assessment complete • Status: Yale service organization in progress, implementation discussion during this visit

  5. Sub-project B: Support for Study Files Management • Mayo checklists and templates for • support to study teams • Mayo knowledge shared to Yale • Yale Assessment complete • Status: Yale determining how best to implement, currently available as tools on the web

  6. Sub-project C: Research Assistant/Nursing Pool for Investigators • Yale knowledge shared to Mayo • Mayo Assessment complete • Status: Mayo determined this was not feasible to implement • YCCI nurse/coordinator pool

  7. Sub-project D: Exploration of IT Solutions • Mayo: • IND/IDE Tracking System • Grant and Publications Tracking and Reporting • Clinicaltrials.gov registration facilitation • Mayo systems presented to Yale • Yale Assessment Complete • Status: Working to transfer modified Grants & Publications System to Yale; Transfer Team in place, Mayo IT on site with Yale today

  8. Sub-project E: Facilitation of Clinicaltrials.gov reporting requirements • Developing team to evaluate effective practices for providing support • Goal: share ideas and jointly develop solutions • Mayo and Yale to work together to identify solutions in support of studies

  9. Project Strategy/Timeline • Presentation/sharing of information, e.g., support model/service/solution- COMPLETE • In depth assessment of feasibility of adoption of support model/service/solution- COMPLETE • Includes evaluation of cost efficiencies • Development of implementation strategy and timeline

  10. Project Deliverables • FDA audit service model including tools & checklists for investigators and studies • Study Files Management checklists and templates • Info swap, Assessment/Evaluation, and Implementation model and guidance to consort. • Grant and Publications Tracking and Reporting IT Tool • Jointly developed clinicaltrials.gov reporting rqmt solutions

  11. Lessons Learned • Development of lessons learned guidance to accompany collaboration/practice improvement sharing model, including: • Cost savings/cost avoidance lessons • Did the collaboration results challenge the assumptions made about sharing practices? • Implementation lessons (budgetary, organizationally, etc.)

  12. Lessons Learned (to date) • Site transferring tools/processes gains feedback and ideas for improvement • Site receiving tools/processes saves time with original creation, but needs to plan for modifications specific to site use, wording, audience, etc • IT systems may not be easily transferred (assessment is key)

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