1. University of Hawaii Clinical Research Center Louise Medina, R.N., M.H.A. Clinical Program Administrator

2. Presentation Outline Brief Overview of the CRC Program CRC Services & Support CRC Application & Review Process CRC Resources & Contacts Questions & Answers

3. Origins of the UH CRC Research Centers in Minority Institutions Infrastructure grant awarded to: University of Hawaii (UH) Kapiolani Medical Center for Women and Children (KMCWC) subcontract Established in 1995 Funding agency:

4. CRC Mission To foster: Clinical, investigator-originated research on disorders disparately affecting minority populations career development of junior and minority investigators interdisciplinary, collaborative, community-oriented research

5. CRC Purpose Provide clinical research infrastructure support on protocols approved by the CRC Scientific Advisory Committee (SAC) including: Research personnel support Access to clinical facilities and equipment Limited funding

6. CRC Research Priorities Clinical (patient-oriented) research Investigator-originated proposals NIH or other extramurally funded proposals Health disparities research Career development of clinical investigators

7. CRC Leadership Principal Investigator Edwin Cadman, M.D. Dean, John A. Burns School of Medicine University of Hawaii at Manoa Program Director David Easa, M.D. Associate Dean for Clinical Research John A. Burns School of Medicine University of Hawaii at Manoa

8. CRC Locations Kapiolani Medical Center for Women and Children, Bingham Bldg., 1 st Floor Gold Bond Building 677 Ala Moana Blvd., Suite 1015 Clinical Facility Administrative Office

9. New UH School of Medicine & Biotech Park in Kakaako:

10. CRC Services & Support

11. CRC Infrastructure Support Research personnel support Access to clinical facilities and equipment Funding

12. CRC Personnel Protocol Development Team  Epidemiologists / Biostatisticians  Computer Specialist  Research Subjects Advocate  Protocol / Grants Coordinator Clinical Team  Nurse Manager  Research Nurse Coordinators  Study Coordinators  Lab Assistant  Receptionist Administrative Team  Program Director / Administrator  Grants Management Specialist  Administrative Assistant

13. CRC Services Protocol & grants development Computer / database support Epi / biostatistical consultation (study design, data analysis, preparation and submission of abstracts/manuscripts) Clinical study implementation (subject recruitment, study coordination, clinical assessments & procedures, lab support, data collection/entry, chart reviews, etc.)

14. CRC Clinical Facility  Kapi‘olani Medical Center for Women and Children

15. 4 Clinical Exam Rooms

16. Specialized Equipment GE Medical DEXA Bone Densitometer

17. Processing Laboratory

18. Patient Reception Area

19. Conference Room

20. CRC Clinic Hours of Operation Mon-FriSatSun Clinic Hours 8:00 am to 4:30 pm Variable

21. CRC Clinical Personnel Support

22. KMCWC and Offsite Study Visits

23. Offsite Study Visits

24. Funding Limited funding available (  $10,000) supplies small equipment patient care costs (lab, ancillary charges) patient reimbursement for time & travel 1 year award period; may request additional year (no-cost extension)

25. Investigator Obligations Acknowledge CRC grant in abstracts, manuscripts, scientific presentations “This investigation/manuscript/etc. was supported by a Research Centers in Minority Institutions award, P20 RR11091, from the National Center for Research Resources, National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCRR/NIH.” “This investigation/manuscript/etc. was supported by a Research Centers in Minority Institutions award, P20 RR11091, from the National Center for Research Resources, National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCRR/NIH.” Submit annual progress report Keep CRC apprised of your research accomplishments (grant awards, fellowships, etc.)

26. CRC Application and Review Process

27. To request CRC support… Contact the CRC to request an application: Email: crcuh@hawaii.edu Call: Joanne Mor at 587-8574

28. Protocol Review Process Protocol Submission to CRC PDT Meeting(s) SAC IRB(s) APPROVED CRC Support Begins APPROVED Approved Approved pending modifications DeferredDisapproved Approved DeferredDisapproved ++

29. Timeline for Submission & Review Initial application due Final application due SAC Review Date September07/01/0408/01/0409/08/04 December10/01/0411/01/0412/01/04 March01/01/0502/01/05 03/09/05* June04/01/0505/01/05 06/08/05* * tentative

30. CRC Resources and Key Contacts http://www.pbrc.hawaii.edu/crc/crcuh@hawaii.edu CRC staff list (handout)

31. Questions ?

32. Mahalo from the UH CRC