1. University of Rochester Clinical and Translational Science Institute Clinical & Translational Science Institute The Research Navigator Program: A Full-Service Research Help Desk Thomas T. Fogg MS MPH Executive Director for Operations University of Rochester Clinical and Translational Science Institute February 22, 2011

2. University of Rochester

3. University of Rochester Medical Center

4. Clinical and Translational Science Institute

5. Clinical & Translational Science Institute Four Specific Aims of the UR-CTSI 1.Create an academic home for clinical and translational research at the University of Rochester. 2.Organize services to better support investigators and their projects. 3.Create or reorganize four Centers of Research Excellence across the translational research spectrum. 4.Offer a broad range of education and training opportunities in clinical and translational research.

6. Clinical & Translational Science Institute Four Specific Aims of the UR-CTSI 1.Create an academic home for clinical and translational research at the University of Rochester. 2.Organize services to better support investigators and their projects. 3.Create or reorganize four Centers of Research Excellence across the translational research spectrum. 4.Offer a broad range of education and training opportunities in clinical and translational research.

7. Clinical & Translational Science Institute The Research Navigator Program functions as the University research “help desk.” Research Navigator Program

8. Clinical & Translational Science Institute Mission: link researchers to resources, tools and collaborators Mechanisms: –Web-hosted guidance –Personalized assistance The Research Navigator Program functions as the University research “help desk.” Research Navigator Program

9. Clinical & Translational Science Institute Research Navigator Program

10. Clinical & Translational Science Institute Research Navigator Program

11. Clinical & Translational Science Institute Customized Action Plan (CAP) Online tool –Guides investigators –What you need to know to plan and operate a study CAP Report  Required approvals  Available services  Links to forms and policies  Where to go for help CAP Reports –stored online –can be exported as PDFs with live links

12. Clinical & Translational Science Institute CAP Question Structure

13. Clinical & Translational Science Institute CAP Report Structure

14. Clinical & Translational Science Institute CAP: a tool for facilitated planning CAP Demonstration

15. Clinical & Translational Science Institute Research Navigator Program

16. Clinical & Translational Science Institute Research Navigator Program

17. Clinical & Translational Science Institute Requesting Assistance  Submit questions and general requests by email reg_support@urmc.rochester.edu  Request consultation services and vouchers through the CTSI Online Consultation Services Tool  All requests receive responses within 48 hours of submission

18. Clinical & Translational Science Institute Consultation Services The Research Navigator Program facilitates access to a range of consultation services for personalized assistance.  CTSI-supported services  Other services at the institution  Services outside the institution

19. Clinical & Translational Science Institute Consultation Services Includes –Identifying potentially useful services –Advice regarding likely benefit of in-person consultation Follow-up –Not just a hand-off –Support initiation of consultation –Check back

20. Clinical & Translational Science Institute Available Services  Biomedical Informatics  Biostatistics  Clinical Research Ethics  Support for ClinicalTrials.gov  Community Engagement  Cost Effectiveness  Data management  Epidemiology  IND/IDE support & other FDA compliance  Human Behavior Assessment  Human Subject Recruitment & Retention  Laboratory Assays  Molecular Biology Analytics  Physical Exercise, Activity & Kinesiology (PEAK) Lab  Regulatory Support  Survey design and conduct Mix of CTSI-supported and fee-based services List is expanding

21. Clinical & Translational Science Institute Research Navigator Program

22. Clinical & Translational Science Institute Research Navigator Program

23. Clinical & Translational Science Institute CTSI Voucher System Some services have fees CTSI vouchers –Standard: Up to 10 hours of fee-based consultation services Limit of one voucher for the lifetime of a project Good for 90 days –Jumbo Up to 40 hours of service Must be approved by CTSI Executive Committee

24. Clinical & Translational Science Institute Voucher Eligibility URMC investigator Clinical or translational research Without grant support for a project Not available to support grant-writing

25. Clinical & Translational Science Institute Online Consultation Request Tool Consultation Tool Demo

27. Clinical & Translational Science Institute Staffing Eric Rubinstein JD MPH, Director, Regulatory Knowledge and Support Joan Adamo PhD, Co-Director, RKS and Research Navigator Shanti Sharma PhD, Research Navigator Mark Plessinger PhD, Research Navigator Nancy Needler RN, Research Subject Advocate Lauren Farberman MBA, Administrator, Research Navigator Program

28. Clinical & Translational Science Institute # of Program Contacts Totals 34 w/ voucher 38 w/o voucher

29. Clinical & Translational Science Institute By Service Type Note - some encounters were for multiple services