1. Clinical Research Town Hall SCHOOL OF MEDICINE 1 September 2, 2015 Linda Duska, MD MPH Olga Kipnis, MS

2. Areas of focus Clinical research volume- what are the data? Enhanced support for clinical research – Clinical research unit (CRU) – Pharmacy – Clinical Trials office (CTO) – Grants and contracts – EPIC Clinical Research improvement in systems and processes (CRISP) 2

3. SOM clinical research: Getting a handle on the data Grants and Contracts Data – Clinical Trial Awards (new and ongoing) 2012-2013354 2013-2014357 2014-2015383 – Budget data 3 Budget fiscal yearTotal costs awarded Percent increase 2012-20139,397,899- 2013-201410,399,49110.6% 2014-201511,205,03819.2%

4. SOM clinical research: Getting a handle on the IRB data 4 # of protocols Year

5. SOM clinical research: Cancer Center data Annual Therapeutic Accruals 2010-2014 5 20142015 (through 06/30/2015) Bio Repository TrialsOnsite125Bio Repository TrialsOnsite 45 Patient Registry TrialsOnsite11Patient Registry TrialsOnsite 4 Prevention TrialsOnsite61Prevention TrialsOnsite 9 Quality of Life TrialsOnsite0Quality of Life TrialsOnsite 0 Screening TrialsOnsite3Screening TrialsOnsite 1 Treatment TrialsOnsite245Treatment TrialsOnsite 131 Economics of CareOnsite0Economics of CareOnsite 0 OtherOnsite110OtherOnsite 63 Total555Total 253 Calendar Year 20102011201220132014 Total Number of Therapeutic Accruals129152208184 234 % of Patients Accrued to Therapeutic Trials4.6%5.5%6.7% 8.1% Number of analytic cases 2970249827502625

6. Barringer Clinical Research Unit Users since opening (Dec 2013) 97 PIs (many with multiple studies) 11 SOM Departments 5 departments outside of the SOM Other services (available 24/7, at 3 sites) – Lab sample processing space Refrigerated centrifuge – Temporary freezer space -20 freezer, -80 freezer 6

7. Clinical Research Unit Usage Barringer 3

8. Ivy building Entire building devoted to clinical and translational research (with a new CRU) Groups that will be there: – Outcomes research (cancer center, medicine and PHS) – Psychiatry and neurobehavioral sciences – UVA CLEAR (Nassima Ait-Daoud ) – Artificial pancreas research group (Boris Kovatchev) – Epilepsy group (Nathan Fountain) – MS group (Myla Goldman) – The Virginia Center for Translational and Regulatory Research (Robert Meyer) 8 Ivy Building CRU to open October 2015

9. Enhanced support for clinical trials Addition of one pharmacist to EACH of the two investigational pharmacies – Plans for a meeting to discuss prioritization of protocols Addition of a full time Project Manager to the SOM Clinical Trials Office Addition of two contract negotiators to Grants and Contracts EPIC updates November 2017 9

10. Clinical Research Improvement in Systems and Processes (CRISP)

11. Thanks to Project Workgroup Cricket Birk, RN CCRN Clinical Research Coordinator, Department of Anesthesiology Sandra Burks, RN, BSN, CCRC Associate Director, Surgical Therapeutic Advancement Center Stewart P. Craig, MS Assistant Dean for Research Administration Director, Office of Grants and Contracts Lori Elder, RN BSN CCRA Director, SOM Clinical Trials Office Susie Hoffman, RN BSN CIP Director: IRB for Health Sciences Research Lynn Koplin, M.A., CRCP Assistant Director of Contracts, Office of Sponsored Programs Johanna Loomba, BS, CCRC Director, UVa Neurosurgery Clinical Research Goga Radakovic, MD, CCRC Director, Office of Clinical Research, Cancer Center Catherine A. Reniere, MA Cancer Informatics Program Manager

12. Thanks to Project Advisory Amy P. Adams, PharmD, CCRP Coordinator, Investigational Drug Service Chris G. Allison Manager of Billing and Collections, UPG Lauren C. Benusa, Pharm.D. Investigational Drug Services Coordinator Amy Camblos, BS Project Manager Jennifer Crosby, BS, CCRP Clinical Trials Budget & Billing Coordinator Patrick Dillon, MD Assistant Professor of Medicine Amy C. Fansler, MPH CCRP Clinical Research Program Manager, Neurological Emergencies Nathan B. Fountain, MD Professor of Neurology Director, FE Dreifuss Comprehensive Epilepsy Program Leisa Gonnella, MHA, CPC Finance Administrator, Department of Anesthesiology Dina Gould Halme, PhD Associate Director, Research Program Administration, Cancer Center David Kaufman, MD Professor of Pediatrics, NICU Clinical Trials Group Director Robert Meyer, MD Director, VCTRS Assc. Professor, Public Health Sciences Jonathon Neel, MS, CISM, CISSP Information Security and Risk Management Officer, School of Medicine Wendy M. Novicoff, Ph.D Associate Professor Department of Public Health Sciences and Orthopaedic Surgery Kathy Richardson Clinical Trials Office Budget & Billing coordinator Michael Salerno, MD, PhD Assistant Professor of Medicine, Radiology, and Biomedical Engineering Angela Sherman, CRA Manager of Sponsored Projects Administration, School of Medicine Richard D. Stevenson, M.D. Professor of Pediatrics Chief, Division of Developmental Pediatrics Medical Director, UVA Child Development and Rehabilitation Center Chair, Institutional Review Board - HSR Ronald B. Turner, M.D. Professor of Pediatrics

13. Thanks to Project Stakeholders Lee Baszczewski, BA, PMP, Lean – Black Belt Director, Organizational Excellence, University of Virginia Linda R. Duska, MD, MPH Professor of Obstetrics and Gynecology Interim Associate Dean for Clinical Research David J. Hudson, PhD Associate VP for Research, University of Virginia Christopher M. Kramer, MD Ruth C. Heede Professor of Cardiology Professor of Radiology Michael R. Marquardt, MBA, MPH Chief of Staff, Office of the Executive Vice President for Health Affairs Margaret A. Shupnik, Ph.D. Professor of Medicine and Physiology, Division of Endocrinology and Metabolism Senior Associate Dean for Research

14. Thanks to Project Leadership Thea Grover-Patrick, MBA Director, Strategic Initiatives, Health System Sean Jackson, D.M.A Chief Information Officer, School of Medicine & University of Virginia Physicians Group Paul V Targonski, MD, PhD, MPH Associate Professor of Department of Public Health Sciences and Director for Clinical Research Initiatives Olga Kipnis, MS Project Manager

15. Initial focus on study start-up Study Start-up Study Conduct Study Close-Out Clinical Research Study Results Scientific Investigation Clinical Research Study Management Institutional Review Board & Compliance Budget Ancillary services Contract execution PTAO Billing End: the study is ready to enroll subjects Start: protocol (sponsor, design) AND Established Funding Source

16. We started the journey by examining our current state Team’s comprehensive and detailed input, value stream analysis, and root causes. Additional interviews. Survey development to better understand our current performance and hear ideas for priorities and improvement. Survey invitation sent to SOM, Interns/Residents with active IRB Protocols. We followed up with Department/Center administrators. Survey was open during: April 29 - May 12, 2015.

17. Our start-up is not effectively positioned for success Organization and management in vertical silos. Work is performed in parallel, however not effectively coordinated for throughput. Processes are not clearly defined. No effective prioritization across the value stream. Standardization of processes is minimal. The feasibility assessment is not consistently defined or critically managed.

18. Survey results: start-up timeline Survey results: entire process of a study start –up, for studies that go through a Full Board review

19. Survey results: start-up satisfaction Survey results: entire process of a study start –up, for studies that go through a Full Board review

20. 20 Listening to customers

21. Improve process and systems Simplify submission and provide visibility Reduce turnaround time And, additional meaningful suggestions: Align expectations: Tell us what/when to expect. Give us ways to find contacts, resources, and items you require us to complete. Provide unified responses to requirements. Increase [our] ability to prepare and negotiate budget. We advocate for improved feasibility assessment and need help. Provide more support, especially for researchers and study coordinators new to our process. Are we an overly risk adverse institution? 21 Listening to customers

22. Focusing on meaningful change and adding value Focusing on principal investigators, clinical research coordinators, departments/centers, institution Using Lean methodology to identify and eliminate waste Standardizing (“Easy” & “Comprehensive”) Educating and supporting in the process Learning from peer institutions: There is no “silver-bullet” system Change management and planning Support is typically underestimated Importance of value stream ownership and IT support

23. Institutional Review Board and Compliance Ancillary Services Budget / Cost Analysis and Grant Pricing Request Contract Execution PTAOs Creation Billing Coverage Analysis & Billing Set-up Creating target condition Clinical Research Study Start-Up General study information Streamlined process Visibility and transparency Single data entry Electronic submission Ability to see status and map of the process Ability to see reasons for decisions and comments Email notifications Ability to sign electronically Ability to manage documents Helpful checklists Portfolio of studies and reporting Integration

24. Exploring systems integration Clinical Research Study Start-Up ResearchUVa IRB Protocol Builder IRB Online Clinical Research Study Management Epic phase 2 Study Start-Up Study ConductStudy Close-Out General study information IRB Approval Assurance form, Protocol, Consent(s) Approved contract negotiation information (Goldenrod) Executed Clinical Trials Agreement(s) Approved Billing Coverage Analysis Approved budget PTAO information

25. Choosing unique foundation Support and Education Automation Process Improvement Elimination of Waste Increase customer satisfaction Increase process awareness Increase quality: achieving perfect submission Meet target enrollment goals Reduce time to complete the start-up Establish UVA as a leader in clinical research management Continuous Improvement Developing People

26. Future State Specification September 2015 - 2016 Moving forward, next steps Start Implementation Data and integration Flow of the submission and approval Security model PDCA – Plan, Do, Check, Act Continuous Improvement

27. 27 “If you want something you have never had, you must be willing to do something you have never done.” Thomas Jefferson Thank You!

28. What would be helpful to you as we continue the process? http://cr.med.virginia.edu