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CTSA Champions of Change Meeting May 4, 2011 1:00PM – 2:00PM ET

CTSA Champions of Change Meeting May 4, 2011 1:00PM – 2:00PM ET. Meeting Agenda. Goal of Champions of Change

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CTSA Champions of Change Meeting May 4, 2011 1:00PM – 2:00PM ET

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  1. CTSAChampions of Change MeetingMay 4, 2011 1:00PM – 2:00PM ET

  2. Meeting Agenda

  3. Goal of Champions of Change The Champions of Change support the goals of SGC#1 by implementing, measuring, and reporting process improvement in clinical-research management and supporting performance standards at each CTSA site and across the CTSA Consortium.

  4. Process - Champions of Change Facilitate Institutional Implementation by: • Receiving a charge from SGC #1 ; • Organizing into small groups around • common institutional structures, specific to • the individual initiative; and • Facilitating Implementation of a taskforce- • developed initiative.

  5. Charge from SGC#1 PIs Hugh Sampson and Jim Heubi Strategic Goal Committee #1 Principal Investigators

  6. 2nd IRB Processing Survey Update Study Co-Chairs: Ray Hutchinson, University of Michigan Nichelle Cobb, University of Wisconsin-Madison

  7. Updates • Status of project • Beta testing of study instrument completed last week • Comments to programmers • Final review of revisions to instrument, updates to orientation PowerPoints, minor tweaks to protocol • Orientation sessions for data coordinators being scheduled – invitation out last Friday • Thursday, May 12, 4-5 pm ET • Friday, May 13, 10-11 am ET • Recording sessions for those who cannot attend • Rollout still planned for May 23, 2011

  8. Feedback from testing • Testers impressed with instrument • More a web-based program with branching and automated calculations than traditional survey • Few problems, questions • Some changes to better clarify questions • Survey is long (we expected this reaction) • Developed worksheet to help with data collection

  9. Questions and Comments

  10. Clinical Research Management Workshop Agenda for June 20-21 Royce Sampson & Jane Strasser, Co-Chairs Clinical Research Management Workshop Planning Group

  11. Pre- Meeting Improvements that Work: How to Create Efficiency in Clinical Research Management Sunday, June 19 (Pre-Meeting Optional Networking)* 4:30 PM – 7:00 PM (150 min) (Pre-Meeting Meeting Time Available) 6:00 PM – 7:00 PM (60 min) Drop in Networking Reception (Cash Bar) Monday, June 20 6:45 AM – 8:00 AM (75 min) Registration/Packet Pick-Up 7:00 AM – 8:00 AM (60 min) Coffee/Continental Breakfast

  12. Day 1 8:00 AM – 8:10 AM (10 min) Welcoming Remarks Barbara Alving, M.D. (Director, National Center for Research Resources) 8:10 AM – 8:15 AM (5 min)Purpose and Organization of Meeting • Royce Sampson, MSN, R.N., CRA (Chief Operations Officer, South Carolina Clinical & Translational Research Institute, Medical University of South Carolina) • Jane Strasser, Ph.D. (Associate Vice President for Research, University of Cincinnati) • Dan Rosenblum, M.D. (Program Officer, National Center for Research Resources) 8:15 AM – 9:15 AM (60 min)Keynote Address – Regulatory Science – Modernizing Drug Development • Vicki Seyfert-Margolis, Ph.D. (Senior Advisor for Science, Innovation, & Policy, Food and Drug Administration)

  13. Day 1 9:15 AM – 10:30 AM (75 min) Panel: Alternative IRB Approvals for Multisite Trials • Moderator: Barbara Bierer, M.D. (Sr. Vice President, Harvard) • Nichelle Cobb, Ph.D. (Director Health Sci. IRB Office, University of Wisconsin Madison) • Steven Hirschfeld, M.D., Ph.D. (Associate Director for Clinical Research, National Institute of Child Health and Human Development) 10:30 AM – 10:45 AM (15 min) BREAK 10:45 AM – 12:00 PM (75 min) Panel – “Implementing Pre-study Improvements: Process Mapping,” • Moderator: Bruce Cronstein, M.D.(New York University School of Medicine, CTSA and SGC1 PI) • David Dilts, Ph.D., MBA, CMA (Director of Clinical Research, Knight Cancer Institute, Oregon Health & Science University) • Muhanad Hirzallah, Ph.D. (Director, Business Applications, Research Administrative Services, Mayo Clinic) • Sabi Singh, M.S., M.A. (Assistant Vice President for Operational Excellence and Quality/Safety; University of Iowa)

  14. Day 1 12:00 PM – 12:30 PM (30 min) Pick up lunch 12:30 PM – 1:45 PM (75 min) Panel – “Documenting Pre-study Improvements: Tracking, Analysis, and Readjustment” • Moderator: Hugh Sampson, M.D. (Mt Sinai CTSA and SGC1 PI) • Scott Schuetze, M.D., Ph.D. (Associate Professor, University of Michigan) • Elan Czeisler (CIP Director; New York University School of Medicine IRB) • Michael aligiuri, Ph.D. (Director of the Clinical Research Protections, UC San Diego) 1:45 PM – 1:55 PM (10 min) Travel to breakout

  15. Day 1 1:55 PM – 2:50 PM (50 min) Breakout Session One To maximize the value of the workshop there are 2 breakout sessions for smaller group discussions focused on examples of processes in need of improvement and successful improvement strategies.  Please click (https://www.surveymonkey.com/s/CRMWS_Breakout_Topics) to tell us what topic(s) you would most like to see discussed. 2:50 PM – 3:00 PM (10 min) BREAK 3:00 PM – 3:50 PM (50 min) Breakout Session Two To maximize the value of the workshop there are 2 breakout sessions for smaller group discussions focused on examples of processes in need of improvement and successful improvement strategies.  Please click (https://www.surveymonkey.com/s/CRMWS_Breakout_Topics) to tell us what topic(s) you would most like to see discussed.

  16. Day 1 3:50 PM – 4:00 PM (10 min) BREAK 4:00 PM – 7:00 PM (60 min) ** Presenters to stay with posters for assigned time (2 30-minute blocks) ** Poster Presentations, exhibitor interaction and networking reception Cash Bar. Summaries of breakouts will be available.   Possibilities for networking 5:00 PM – 5:15 PM (15 min) Report Back: Breakout Sessions 1 & 2 Question and Answer and Discussion Session 5:20 PM – 5:30 PM (10 min) Charge from Principal Investigators 6:00 PM – 7:00 PM (60 min) Networking Socials with charge from Principal Investigators

  17. Day 2 7:00 AM – 7:30 AM (30 min) Coffee/Continental Breakfast 7:30 AM – 7:35 AM (5 min) Purpose and Plan for Day 2  Royce Sampson, MSN, Jane Strasser, Ph.D., Dan Rosenblum, M.D. 7:35 AM – 8:35 AM (60 min) Panel – “Cost Effective Management a Clinical Research Unit” • Moderator: Don McClain, M.D. Ph.D. (Utah CTSA PI) • Arlene Chapman, M.D. (Program Director, Clinical Interaction Network, Emory University) • Blythe Thompson, M.D. (Clinical Associate Professor, University of Washington) • Yi Zhang, J.D., R.N. (Assistant Dean for Clinical Trials, Washington University) 8:35 AM – 9:35 AM (60 min) Panel – “How to Evaluate Processes/Monitor Change Related to Study Development and Review” • Moderator: James Heubi, M.D. (University of Cincinnati CTSA andSGC1 PI) • Co-PIs of Contract Study: Adam Rifkind (Associate Director, Corporate Contracts, University of Pennsylvania) and Libby Salberg J.D.(Director, Office of Grants and Contract Management, Vanderbilt University) • Mark Drezner, M.D., Chair, MAM (Associate Dean, Professor of Medicine University of Wisconsin-Madison) • William Trochim,Ph.D., M.A. (Weill Cornell Medical College)

  18. Day 2 9:35 AM – 9:45 AM (10 min)Discussion 9:45 AM – 10:00 AM (15 min)Break 10:00 AM – 10:30 AM (30 min) Recruitment & Retention  Rhonda G. Kost, M.D. (Clinical Research Officer, Rockefeller University Center for Clinical and Translational Science) 10:30 AM –10:45 AM (15 min)Panel –The Internal Costs of Non-enrollment •  Moderator: Rhonda G. Kost, M.D. (Clinical Research Officer, Rockefeller University Center for Clinical and Translational Science) • Nick Gaich (Executive Director, COO, Spectrum, Stanford University) • Steve Alexander, M.D. (Medical Director, Spectrum Operations, Training and Compliance Stanford University CTSA) 10:45 AM –11:00 AM (15 min)Got ResearchMatch?  The Top 10 Ways It's Working Laurie A. Lebo, Ph.D., CCRP, PMP (Program Manager, ResearchMatch Vanderbilt Institute for Clinical and Translational Research) 11:00 AM –11:15 AM (15 min)Recruitment Services & Successes at the Ohio State University CCTS  Rose Kegler Hallarn. (Clinical Trials Recruitment Program Director, Ohio State University, Center for Clinical and Translational Science)

  19. Day 2 11:15 AM – 12:05 PM (50 min) NCI Web-Based Support for Recruitment (AccrualNet) http://accrualnet.acscreativeclients.com/  Linda Parreco, R.N., M.S.(Head, Protocol Information Office, National Cancer Institute) 12:05 PM – 12:15 PM (10 min) ARRA Supplement in Support of Strategic Goal Committee #1 –“Exploiting Data from the Cystic Fibrosis Therapeutics Development Network (CF-TDN)” •  Bonnie Ramsey, M.D. (Associate Program Director of the University of Washington General Clinical Research Center) 12:15 PM –12:35 PM (20 min) ARRA Supplement in Support of Strategic Goal Committee #1 – “Sharing Best Practices Between CTSA Sites” • Michael Pfenning (Director for Administration, Mayo Clinic) • Tesheia Johnson, MBA, MHS (Associate Director for Clinical Research • Yale School of Medicine, COO Yale Center for Clinical Investigation) 12:35 PM – 1:00 PM (25 min)Summary and Recommendations for Further Action • Hugh Sampson, M.D. (UC, San Francisco CTSA and SGC1 PI) • Questions and Comments from the Floor • Topics for next Workshop • Webinars and other educational materials 1:00 PM Adjournment Networking?

  20. Questions and Comments

  21. Next Steps

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