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Coordinating Center: Overview What is a Coordinating Center?

Coordinating Center: Overview What is a Coordinating Center? What is the purpose of a Coordinating Center? Why do we need a Coordinating Center? What is the Center’s structure and functions? How will we relate to one another?. What is a Coordinating Center?

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Coordinating Center: Overview What is a Coordinating Center?

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  1. Coordinating Center: Overview • What is a Coordinating Center? • What is the purpose of a Coordinating Center? • Why do we need a Coordinating Center? • What is the Center’s structure and functions? • How will we relate to one another?

  2. What is a Coordinating Center? • A means of organizing, supporting, and managing multiple sites, studies, or programs committed to a common goal • A vehicle for translating broad goals and objectives into uniform action • An administrative bridge between a sponsoring agency and community participants • The hub in a communications network that ensures synchronized effort

  3. What is the purpose of a Coordinating Center? • The primary mission of a Coordinating Center is to: • Assure the integrity and validity of the effort so that the results are meritorious • Document the process and outcomes of the effort in accordance with widely accept standards of evidence • Disseminate the results to audiences in easily understood terms that promote the effort’s contin-ued support and adoption by others

  4. Why do we need a Coordinating Center? • Specialized experience, capacity, and infrastructure to plan, implement, evaluate, report, and disseminate an effort of this magnitude • Rigorous design, yet thoughtful allowance for local variation in select areas • Broad expertise in the evaluation of demonstration projects, especially in regard to their processes and outcomes

  5. Why do we need a Coordinating Center? • Keen understanding of human participant protections and relevant regulations • Sophisticated data management and analytic skills in order to reveal the successes • Ability to document and disseminate progress in a varied, but timely manner • Need to marry good science with locally meaningful benefits

  6. What is this Center’s structure and functions? • This Coordinating Center has 6 core components: • Administrative Core • Data Core • Resource Core • Human Participant Protections Core • Information Technology Core • Dissemination Core

  7. Administrative Core: Structure Core staff • Patricia Licari, MSHA, Associate Director • Alisa Katai, MHA, Coordinator, Diabetes Prevention • Sandra Woodruff, MSPH, Coordinator, CVD Risk • Lori Trullinger, Operations Coordinator • Dawn Wright, MBA, Fiscal Coordinator • Rhonda Dick, BS, CNE, Technology Coordinator • Program Assistants (To Be Named)

  8. Administrative Core: Structure • Executive Committee • Yvette Roubideaux, MD, MPH, co- directs the Center • and chairs the Executive Committee. • Core administrative and support staff meet once • weekly to review progress and assignments • Steering Committee Spero M. Manson, PhD, directs the Administrative Core and chairs the Steering Committee. • Steering Committee meets 6 times in Year-01.

  9. Administrative Core: Functions • Supports the logistical operations of each Core component • Stimulates, coordinates, and monitors activities across Core components • Supervises implementation of key strategic decisions related to the program plan • Facilitates program planning and review

  10. Data Core: Structure Core staff • William Henderson, PhD, Lead Consultant • Alisa Katai, MHA, Coordinator, Diabetes Prevention • Sandra Woodruff, MSPH, Coordinator, CVD Risk • Lori Jervis, PhD, Process Evaluator • Paul Spicer, PhD, Process Evaluator • Statistician (2), To Be Named • Computer Programmer (2), To Be Named • Jeanne Amos, BA, Data Coordinator, CVD • Karen Rogers, BA, Data Coordinator, DP • Data Entry (2), To Be Named

  11. Data Core: Functions • Creates and distributes study materials, notably a manual of data operations and supporting documents, and training local data managers/coordinators in these procedures • Assists in constructing, maintaining, and using local registries to identify and prioritize participant recruitment • Coordinates and supervises data collection

  12. Data Core: Functions • Obtains, processes, conducts quality control, compiles, and manages the data • Develops and supports mechanisms for monitoring intervention fidelity • Analyzes process and outcome data in accordance with IHS/DDTP and Congressional requirements

  13. Data Core: Functions • Develops report templates, completes and forwards same to the appropriate parties in a timely fashion • Assists in preparing all dissemination products

  14. Resource Core: Structure Core staff • Yvette Roubideaux, MD, MPH, Core Director • Lori Prucha, Coordinator • Melanie Mandelin, MD, Consultant • Program Assistants (To Be Named)

  15. Resource Core: Functions • Gathers input on a regular basis to assess the specific technical assistance needs of grantees • Designs technical assistance and training sessions during grantee meetings • Provides access to technical assistance for grantees as they implement the activities of the demonstration project

  16. Human Participant Protections Core: Structure Core staff • Tim Noe, MDiv, IRB/HIPPA Specialist • Alisa Katai, MHA, Coordinator, DP • Sandra Woodruff, MSPH, Coordinator, CVD • Program Assistant (To Be Named)

  17. Human Participant Protections Core: Functions • Provides leadership regarding human subject protec-tions and ensures that projects adhere to DHHS regulations for the protection of human subjects Title 45, Part 46 of the Code of Federal Regulations (45 CFR part 46). • Addresses issues related to HIPAA (Health Insurance Portability and Accountability Act), the 1996 Act regulating the transfer and collection of Protected Health Information (PHI).

  18. Human Participant Protections Core: Functions • Orients grantees to both sets of protections, and works with regional and national IHS IRBs to clarify the requirements. • Provides technical assistance to program grantees to enable them to complete and submit the necessary protocols.

  19. Information Technology Core: Structure Core staff • Rhonda Dick, BS, CNE, Technology Coordinator • Information Technology Specialist, To Be Named • Web Developer, To Be Named • Program Assistant, To Be Named

  20. Information Technology Core: Functions • Responsible for computer software selection and support • Establishes standards to facilitate compatibility across all program grantees, the IHS/DDTP, the Coordinating Center, and technical experts • Emphasizes minimizing the frequency of software conversions in both text-processing, database management, as well as statistical programming

  21. Information Technology Core: Functions • Works closely with Data Core to develop a centralized data management system that minimizes program grantee responsibility for keying and managing their own data, and maximizes efficiencies in data transfer • Teleform/data fax methods to be used by the Data Core will require coordination with the Information Technology Core to ensure reliable, accurate forwarding of data

  22. Dissemination Core: Structure Core staff • Yvette Roubideaux, MD, MPH, Core Director • Coordinator, To Be Named • Web Developer, To Be Named • Program Assistant (To Be Named)

  23. Dissemination Core: Functions • Provides a comprehensive strategy for communication with and among grantees • Provides a communication link to other SDPI grantees to ensure that they benefit from the findings and lessons learned in the two demonstration projects on an ongoing basis

  24. Dissemination Core: Mechanisms • Mailings • Listserv • Newsletter • Website (public and password protected) • Scientific Publications

  25. How will we relate to one another? • Collaboratively, as partners working toward common goals • Regularly by all means available, with greatest reliance on email, listserv, web-based methods, and teleconferencing • In a timely and responsive manner

  26. How will we relate to one another? • On accomplishing our tasks in order to launch the demonstration projects by October 2005 • Coordinating Center provides programmatic oversight and direction • DDTP/IHS provides fiscal oversight and ensures grant compliance

  27. Information Resources • American Indian and Alaska Native Programs websites: http://www.uchsc.edu/ai/ • Blumenstein B, James KE, Lind BK, Mitchell HE. Functions and organization of coordinating centers for multicenter studies. Cont Clin Trials 1995;16:2S-29S. • Noe T, Fleming C, Manson SM. Healthy Nations: Reducing substance abuse in American Indian and Alaska Native community. J Psychoactive Drugs 2003;35(1):15-25.

  28. Information Resources • Manson SM, Garroutte EM, Goins RT, Nez Henderson P. Access, relevance and control in the research process: Lessons from Indian Country. J Aging Health 2004;16: 58S-77S. • Norton IM, Manson SM. Research in American Indian and Alaska Native communities: Navigating the cultural universe of values and process. J Consult Clin Psych 1996;64(5), 856-860.

  29. Contact Information: Spero M. Manson, PhD, Director spero.manson@uchsc.edu Yvette Roubideaux, MD, MPH, Co-Director yvetter@u.arizona.edu Patricia Licari, MSHA, Associate Director patricia.licari@uchsc.edu Alisa Katai, MHA, Coordinator, DP alisa.katai@uchsc.edu Sandra Woodruff, MSPH, Coordinator, CVD sandra.woodruff@uchsc.edu

  30. Contact Information: Alaska Native Programs Nighthorse Campbell Native Health Building University of Colorado Health Sciences Center Postal Address:       Mail Stop F800                               P.O. Box 6508                               Aurora, CO 80045-0508 Overnight Delivery:   13055 East 17th Avenue                               Aurora, CO 80010 (Tel) (303) 724-1414  (Fax) (303) 724-1474

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