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

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

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:

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

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

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

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

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

New UH School of Medicine & Biotech Park in Kakaako:

CRC Services & Support

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

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

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.)

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

4 Clinical Exam Rooms

Specialized Equipment GE Medical DEXA Bone Densitometer

Processing Laboratory

Patient Reception Area

Conference Room

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

CRC Clinical Personnel Support

KMCWC and Offsite Study Visits

Offsite Study Visits

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)

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.)

CRC Application and Review Process

To request CRC support… Contact the CRC to request an application: Call: Joanne Mor at

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 ++

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

CRC Resources and Key Contacts CRC staff list (handout)

Questions ?

Mahalo from the UH CRC