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Champions of Change Introduction and Charge

Champions of Change Introduction and Charge. March 5, 2009. Champions of Change Barbara Alving, Director, NCRR. Institutional leaders Guide, lead, and advocate for improvement in clinical research management Collaborate across CTSA Consortium Embrace data-driven process improvement.

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Champions of Change Introduction and Charge

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  1. Champions of ChangeIntroduction and Charge March 5, 2009

  2. Champions of ChangeBarbara Alving, Director, NCRR • Institutional leaders • Guide, lead, and advocate for improvement in clinical research management • Collaborate across CTSA Consortium • Embrace data-driven process improvement

  3. Expectation of Champions of Change Barbara Alving, Director, NCRR • Improvement in clinical research management is critical to the mission of CTSA • Consortium needs standards, published data, objective evidence to document improvement • Champions of Change are asked to work together to change the Consortium • NIH, stakeholders, and the public expects CTSA Consortium to “fix what is wrong” with clinical research management.

  4. Governance(Drs. Alving and Ford) • Co-Chairs of Champions of Change (Alving) • Rebbecca Moen, Duke University • Sheila Olson, Mayo Clinic • Committees (Dan Ford, Co-Chair, SGC#1) • IRB Protocol Metrics Pilot • Contracts Protocol Metrics Pilots • Steering Committee on Standardized Metrics • Future: Working with NIH Institutes, Working with commercial partners, Cooperating with AHRRP, Scientific review efficiency, Training for research teams on efficiency, other issues

  5. GovernanceDan Ford • Relationship to SGC#1, National Clinical and Translational Research Capability through Co-Chairs, Committee chairs (if needed) • Brief description of SGC#1 – establishes priorities in CTR capability, meets once a month, coordinates action plans. Major focus on clinical research management process improvement. • NCRR Coordinator: Daniel Rosenblum (rosenblumd@mail.NIH.gov)  (301) 435-4051 • Program Manager: Paymon Hashemi, (hashemi_paymon@bah.com)  (301) 838-3774

  6. Roles of Champions of Change Dan Ford • Institutional Role • Lead improvement • Develop teams • Encourage cultural shifts and team-mentality • Ensure data collection from institution • Use data-driven processes to create change • Advocate change to academic establishment

  7. Roles of Champions of ChangeDan Ford • Consortium Role • Serve on Champions of Change committees in rotation • Determine national policy on process standardization • Disseminate best practices • Assist sites in need of process improvement

  8. Objectives, Milestones, Timelines Tesheia Johnson, Co-Chair, Clinical Research Management KFC • Protocol completion – data for one month in 2009. • Milestones • Data review & analysis May 2009 • Data presentation, Workshop June 2009 • Metrics Development based on data • Implementation of plan to use metrics for process improvement • Future protocols? – We need a plan, milestones, timelines

  9. Objectives, Milestones, Timelines Mike Joyner, Co-Chair Clinical Research Management KFC or Dan Rosenblum, NCRR Coordinator, SGC#1 • Data Repository • Anonymous reporting – REDCap, Vanderbilt • Sites will have access to their own data • Group will receive site-by-site reports of anonymous data • Reports & Analysis • Customized reports through REDCap • Formal analysis and evaluation by expert (Bill Trochim, Cornell University) • Publication ~ Date

  10. CommunicationDan Rosenblum, NCRR Coordinator, SGC#1 • Telephone conferences • E-mail • CTSA website http://www.ctsaweb.org/ and Champions of Change under SGC#1 site: http://www.ctsaweb.org/index.cfm?fuseaction=committee.viewCommittee&com_ID=762 • CTSA Wiki https://www.ctsawiki.org/wiki//x/4oBXAQ (if federated, may use your institutional password; if not federated, contact Paymon Hashemi at hashemi_paymon@bah.com; if unsure, ask)

  11. Brainstorming Session • Annual Workshop [June 22-23, 2009 at NIH [http://www.ctsaweb.org/index.cfm?fuseaction=committee.viewCommittee&com_ID=221 ] All Champions of Change invited and expected to attend along with others from each CTSA. What content and format would help you most? – Tesheia Johnson • Institutional Interventions. How can Consortium activities help your site? Sheila Olson, Co-Chair Champions of Change • Regional Interventions. Can regional meetings leverage action plans for individual site interventions? Rebbecca Moen, Co-Chair Champions of Change

  12. SummaryDan Rosenblum • The Champions of Change are institutional leaders with responsibility for effecting improvement in clinical research management by encouraging participation in implementation of process improvement. • The Champions of Change may use CTSA Consortium support to implement and measure improvement, to exchange ideas, and to develop performance standards. • The Champions of Change are expected to attend the annual Clinical Research Management Workshop and interact with the SGC#1 and the Clinical Research Management Key Function Committee.

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