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Regulatory Knowledge KFC Activities & SGC#1 Objectives

Regulatory Knowledge KFC Activities & SGC#1 Objectives. Rhonda Kost & Kathryn Schuff , Co-Chairs Regulatory Knowledge Key Function Committee. Questions and Comments. Metrics, Analysis, and Mapping Group Reporting Structure. Hugh Sampson, Clay Johnston, and Jim Heubi

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Regulatory Knowledge KFC Activities & SGC#1 Objectives

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  1. Regulatory Knowledge KFC Activities & SGC#1 Objectives • Rhonda Kost & Kathryn Schuff, Co-Chairs • Regulatory Knowledge Key Function Committee

  2. Questions and Comments

  3. Metrics, Analysis, and Mapping Group Reporting Structure • Hugh Sampson, Clay Johnston, and Jim Heubi • Strategic Goal Committee #1 Principal Investigators

  4. Questions and Comments

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

  6. Pre- Meeting Improvements that Work: How to Create Efficiency in Clinical Research Management Sunday, June 19 (Pre-Meeting Optional Networking)* 4:00 PM – 6:00 PM (120 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

  7. 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)

  8. Day 1 9:15 AM – 10:30 AM (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) 10:30 AM – 10:45 AM (15 min) BREAK 10:45 AM – 12:00 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) 12:00 PM – 12:30 PM (30 min) Pick up lunch to take to breakout

  9. Day 1 12:30 PM – 1:25 PM (55 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. 1:25 PM – 1:40 PM (15 min) BREAK 1:40 PM – 2:35 PM (55 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. 2:35 PM – 2:45 PM (10 min) BREAK

  10. Day 1 2:45 PM – 4:00 PM (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) 4:00 PM – 5:00 PM (60 min) Poster Presentations ** Presenters to stay with posters for assigned time (2 30-minute blocks) ** 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 – 7:30 PM (90 min) Networking Socials with charge from Principal Investigators   

  11. 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 – “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) 8:35 AM – 9:35 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)

  12. 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)

  13. 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

  14. Questions and Comments

  15. 2nd IRB Processing Survey Update Study Co-Chairs: Ray Hutchinson, University of Michigan Nichelle Cobb, University of Wisconsin-Madison

  16. Status of project • Final version of the protocol agreed upon 4/4/11 • Data collection tool • Initially developed and alpha tested • Revisions being made • Beta testing next two weeks • Finalize instrument by the end of April

  17. Timeframe • Announce study and orientation sessions to data coordinators early May • Orientation sessions mid-May • Release study instrument on May 23, 2011 • End data collection on July 24, 2011 • Clean data in August • Summary statistics end of September 2011

  18. Questions and Comments

  19. CoFAR/CONCERT Networks – Single IRB Review for Multi-Site Studies IRB Deferral – Lessons from UC-Wide Experience • Jeff Silverstein, Clinical Research Management Co-Chair • Clay Johnston, Strategic Goal Committee #1 Principal Investigator

  20. Questions and Comments

  21. SGC#1 Report to CCEC (April 19th) • Hugh Sampson • Strategic Goal Committee #1 Lead Principal Investigator

  22. Questions and Comments

  23. Recap of Action Items • Rotimi Abimbola, Booz Allen Hamilton • Project Manager

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