University of HawaiiUniversity of Hawaii

Clinical Research CenterClinical Research Center

Louise Medina, R.N., M.H.A.Louise Medina, R.N., M.H.A.Clinical Program AdministratorClinical Program Administrator

Presentation OutlinePresentation OutlineBrief Overview of the CRC ProgramBrief Overview of the CRC Program

CRC Services & SupportCRC Services & Support

CRC Application & Review ProcessCRC Application & Review Process

CRC Resources & ContactsCRC Resources & Contacts

Questions & AnswersQuestions & Answers

Origins of the UH CRCOrigins of the UH CRC

Research Centers in Minority Institutions

Infrastructure grant awarded to:Infrastructure grant awarded to:

University of Hawaii (UH)University of Hawaii (UH)

Kapiolani Medical Center for Women and Children Kapiolani Medical Center for Women and Children (KMCWC) subcontract(KMCWC) subcontract

Established in 1995Established in 1995

Funding agency:Funding agency:

CRC MissionCRC MissionTo foster:To foster:

Clinical, investigator-originated research Clinical, investigator-originated research on disorders disparately affecting on disorders disparately affecting minority populationsminority populations

career development of junior and career development of junior and minority investigatorsminority investigators

interdisciplinary, collaborative, interdisciplinary, collaborative, community-oriented researchcommunity-oriented research

CRC PurposeCRC PurposeProvide clinical research Provide clinical research infrastructureinfrastructure supportsupport on protocols approved by the on protocols approved by the CRC Scientific Advisory Committee CRC Scientific Advisory Committee (SAC) including:(SAC) including:

Research personnel supportResearch personnel support

Access to clinical facilities and equipmentAccess to clinical facilities and equipment

Limited fundingLimited funding

CRC Research PrioritiesCRC Research PrioritiesClinical (patient-oriented) researchClinical (patient-oriented) research

Investigator-originated proposalsInvestigator-originated proposals

NIH or other extramurally funded NIH or other extramurally funded proposalsproposals

Health disparities researchHealth disparities research

Career development of clinical Career development of clinical investigatorsinvestigators

CRC LeadershipCRC LeadershipPrincipal InvestigatorPrincipal InvestigatorEdwin Cadman, M.D.Edwin Cadman, M.D.Dean, Dean, John A. Burns School of MedicineJohn A. Burns School of MedicineUniversity of Hawaii at ManoaUniversity of Hawaii at Manoa

Program DirectorProgram DirectorDavid Easa, M.D.David Easa, M.D.Associate Dean for Clinical ResearchAssociate Dean for Clinical ResearchJohn A. Burns School of MedicineJohn A. Burns School of MedicineUniversity of Hawaii at ManoaUniversity of Hawaii at Manoa

CRC LocationsCRC Locations

Kapiolani Medical Center Kapiolani Medical Center for Women and Children, for Women and Children, Bingham Bldg., 1Bingham Bldg., 1stst Floor Floor

Gold Bond Building Gold Bond Building 677 Ala Moana Blvd., 677 Ala Moana Blvd.,

Suite 1015Suite 1015

Clinical FacilityClinical Facility Administrative OfficeAdministrative Office

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

CRC Services & CRC Services & SupportSupport

CRC Infrastructure SupportCRC Infrastructure Support

Research personnel supportResearch personnel support

Access to clinical facilities and Access to clinical facilities and equipmentequipment

FundingFunding

CRC PersonnelCRC PersonnelProtocol Development TeamProtocol Development Team Epidemiologists / Epidemiologists /

BiostatisticiansBiostatisticians Computer SpecialistComputer Specialist Research Subjects AdvocateResearch Subjects Advocate Protocol / Grants CoordinatorProtocol / Grants Coordinator

Clinical TeamClinical Team Nurse ManagerNurse Manager Research Nurse Research Nurse

CoordinatorsCoordinators Study Study

CoordinatorsCoordinators Lab AssistantLab Assistant ReceptionistReceptionistAdministrative TeamAdministrative Team

Program Director / AdministratorProgram Director / Administrator Grants Management SpecialistGrants Management Specialist Administrative AssistantAdministrative Assistant

CRC ServicesCRC ServicesProtocol & grants development Protocol & grants development

Computer / database supportComputer / database support

Epi / biostatistical consultation (study design, Epi / biostatistical consultation (study design, data analysis, preparation and submission of data analysis, preparation and submission of abstracts/manuscripts)abstracts/manuscripts)

Clinical study implementation (subject Clinical study implementation (subject recruitment, study coordination, clinical recruitment, study coordination, clinical assessments & procedures, lab support, data assessments & procedures, lab support, data collection/entry, chart reviews, etc.)collection/entry, chart reviews, etc.)

CRC Clinical FacilityCRC Clinical Facility

Kapi‘olani Medical Center for Kapi‘olani Medical Center for Women and ChildrenWomen and Children

4 Clinical Exam4 Clinical Exam RoomsRooms

Specialized EquipmentSpecialized Equipment

GE Medical DEXA Bone DensitometerGE Medical DEXA Bone Densitometer

Processing LaboratoryProcessing Laboratory

Patient Reception AreaPatient Reception Area

Conference RoomConference Room

CRC Clinic CRC Clinic Hours of OperationHours of Operation

Mon-FriMon-Fri SatSat SunSun

Clinic Clinic HoursHours

8:00 am to 8:00 am to 4:30 pm4:30 pm

8:00 am to 8:00 am to 4:30 pm4:30 pm VariableVariable

CRC Clinical Personnel SupportCRC Clinical Personnel Support

KMCWC and Offsite Study VisitsKMCWC and Offsite Study Visits

Offsite Study VisitsOffsite Study Visits

FundingFundingLimited funding available (Limited funding available ( $10,000) $10,000)

suppliessupplies

small equipmentsmall equipment

patient care costs (lab, ancillary charges) patient care costs (lab, ancillary charges)

patient reimbursement for time & travelpatient reimbursement for time & travel

1 year award period; may request 1 year award period; may request additional year (no-cost extension)additional year (no-cost extension)

Investigator ObligationsInvestigator ObligationsAcknowledge CRC grant in abstracts, Acknowledge CRC grant in abstracts, manuscripts, scientific presentationsmanuscripts, scientific presentations

““This investigation/manuscript/etc. was supported by a This investigation/manuscript/etc. was supported by a Research Centers in Minority Institutions award, Research Centers in Minority Institutions award, P20 P20 RR11091RR11091, from the National Center for Research , from the National Center for Research Resources, National Institutes of Health.  Its contents Resources, National Institutes of Health.  Its contents are solely the responsibility of the authors and do not are solely the responsibility of the authors and do not necessarily represent the official views of the necessarily represent the official views of the NCRR/NIH.” NCRR/NIH.” 

Submit annual progress reportSubmit annual progress report

Keep CRC apprised of your research Keep CRC apprised of your research accomplishments (grant awards, fellowships, accomplishments (grant awards, fellowships, etc.)etc.)

CRC Application and CRC Application and Review ProcessReview Process

UNIVERSITY OF HAWAI’I KAPI’OLANI AT MANOA HEALTH

Clinical Research Protocol Application (For office use only) CRC #: Date Received: Primary RN:

Protocol Title: (limit 80 characters)

Anticipated start date:

Anticipated end date:

Type of Research: Clinical / Patient Oriented Research Basic Research Principal Investigator: Percent Effort:

Organization: Mailing Address:

Phone Number:

FAX Number:

Pager/Other Number: E-mail Address:

Abstract explanation: State the application’s broad, long-term objectives and specific aims of the project. Describe concisely the research design and methods for achieving these goals. This is meant to serve as a succinct and accurate description of the proposed work. Also, describe the proposed involvement of the CRC (e.g. funding, facility, staff, support, etc.). If the application is funded, this abstract, as is, will be entered into the CRC database and will become public information. Therefore, do not include proprietary/confidential information. Use 10 pt. font. DO NOT EXCEED THE SPACE PROVIDED.

To request CRC support…To request CRC support…

Contact the CRC to Contact the CRC to request an application:request an application:

Email: Email: crcuh@hawaii.educrcuh@hawaii.edu

Call: Joanne Mor at Call: Joanne Mor at 587-8574587-8574

Protocol Review ProcessProtocol Review Process

Protocol Submission to CRCProtocol Submission to CRC

PDT Meeting(s)PDT Meeting(s)

SACSAC

IRB(s) IRB(s) APPROVED

APPROVED

CRC Support Begins CRC Support Begins

APPROVED

APPROVED

ApprovedApproved

Approved pending Approved pending modificationsmodifications

DeferredDeferred

DisapprovedDisapproved

ApprovedApproved

Approved pending Approved pending modificationsmodifications

DeferredDeferred

DisapprovedDisapproved

++ ++

Timeline for Submission & ReviewTimeline for Submission & Review Initial Initial

application application duedue

Final Final application application

duedue

SAC SAC

Review DateReview Date

SeptemberSeptember 07/01/0407/01/04 08/01/0408/01/04 09/08/0409/08/04

DecemberDecember 10/01/0410/01/04 11/01/0411/01/04 12/01/0412/01/04

MarchMarch 01/01/0501/01/05 02/01/0502/01/05 03/09/0503/09/05**

JuneJune 04/01/0504/01/05 05/01/0505/01/05 06/08/0506/08/05**

* tentative* tentative

CRC Resources and Key ContactsCRC Resources and Key Contacts

http://www.pbrc.hawaii.edu/crc/http://www.pbrc.hawaii.edu/crc/

crcuh@hawaii.educrcuh@hawaii.edu

CRC staff list (handout)CRC staff list (handout)

Questions ?Questions ?

MahaloMahalo

from the UH from the UH CRCCRC