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Research/Regulatory Support Services

This initiative aimed to improve research and regulatory support services by fostering collaboration between institutions such as Mayo Clinic and Yale University. Key goals included sharing practices, assessing feasibility, and developing implementation strategies for support models. Sub-projects ranged from centralized coordination for FDA audits to managing study files, exploring informatics solutions, and facilitating clinical trials reporting. Lessons learned emphasize cost savings, effective practice sharing, and the challenges of transferring informatics systems, ultimately aiming to benefit CTSA faculty with minimized barriers and enhanced resources.

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Research/Regulatory Support Services

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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

  2. Purpose/Objectives Identify opportunities to share practices for improvement of each other’s 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. 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 knowledge shared to Yale • Yale Assessment complete • Status: Yale service organization in development, awaiting new hire • Mayo resources: Tools, checklists and process flow for support during FDA audits

  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- will implement • Status: Yale determining how best to disseminate resources for optimal benefit; 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 Informatics 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; Yale working to correct a local issue

  8. Sub-project E: Facilitation of Clinicaltrials.gov reporting requirements • Developing team to evaluate effective practices for providing support; 1st meeting in March • Goal: share ideas and jointly develop potential solutions or models; share with consortium • 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- In progress

  10. Project Deliverables Locally: • Access to the resources of another research service center; information, lessons learned, etc. • Access to the skill set of another institution • FDA audit service modelincluding tools & checklists for investigators and studies • Study files management checklists and templates • Potential clinicaltrials.gov reporting solutions

  11. Project Deliverables Nationally: • Report on collaboration model incl. guidance and lessons learned to consortium • Piloting of Informatics tool transfer • Potential sharing with other CTSA’s • Suggestions for clinicaltrials.gov reporting models

  12. 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.)

  13. 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. • Informatics systems may not be easily transferred (assessment is key)

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