general clinical research center at stony brook

General Clinical Research CenterGeneral Clinical Research Centerat Stony Brook at Stony Brook

General Clinical Research Center General Clinical Research Center at Stony Brookat Stony Brook

NNationalational IInstitutenstitute of of HHealthealthfunded for over $1 million funded for over $1 million per year for center’s per year for center’s operation to help improve operation to help improve health through clinical health through clinical research studies.research studies.Serves as both an inpatient Serves as both an inpatient and outpatient unitand outpatient unit

Nursing Core

Core Lab

Administrative Core

Recruitment

Biostatistical Core

Informatics

&

Data Management

Core

Components of 0ur centerComponents of 0ur center

Research Subject

Advocate

Administrative StaffAdministrative Staff

Nancy WyllieAdministrative Manager

Includes a Program Director, Includes a Program Director, Associate Program Director, Associate Program Director, and support staff for assistance and support staff for assistance with:with:

1) Preparing applications1) Preparing applications

2) Preparing budgets2) Preparing budgets

General Clinical Research CenterGeneral Clinical Research CenterTeamTeam

Taking the frustration Taking the frustration out of clinical research.out of clinical research.Setting up the Setting up the foundation productive foundation productive research. research.

Administrative CoreAdministrative Core

Coordinates and facilitates the Coordinates and facilitates the preparation of all paperworkpreparation of all paperwork

Provides stepProvides step--byby--step protocol step protocol initiation, guidance and initiation, guidance and support.support.

Biostatistical CoreBiostatistical Core

Provides consultation for:Provides consultation for:Experimental designExperimental designSample size/power calculationSample size/power calculationStatistical analysisStatistical analysis

Biostatistical CoreBiostatistical Core

Offers clinicians training inOffers clinicians training in::

Designing a clinical study Designing a clinical study

Basic data analysisBasic data analysis

Informatics and Data Informatics and Data Management CoreManagement Core

Creates:Creates: websites to websites to manage clinical researchmanage clinical research

Provides:Provides: security security computer applications computer applications for protocolsfor protocols

WebsiteWebsite

News & events.News & events.

DiversityDiversity

http://www.sunysb.edu/gcrc

Scan Scan Form Form --11


Conducts:Conducts: daily and archival daily and archival backup on all GCRC serversbackup on all GCRC servers

Offers:Offers: data management data management assistance in:assistance in:

* database and form design * database and form design * data storage* data storage* computer lab facility * computer lab facility


Supplies education on:Supplies education on:

* computer programs * computer programs

* a data management* a data management

Nursing CoreNursing Core

Experienced in:Experienced in:Diverse Nursing SpecialtiesDiverse Nursing Specialties

* Pediatrics* Pediatrics* Geriatrics* Geriatrics* Medicine* Medicine* Surgery* Surgery* Pharmacokinetics * Pharmacokinetics * Research* Research

Nursing StaffNursing Staff

Available Available seven daysseven days a weeka week24 hours24 hours a day for:a day for:

InpatientInpatientOutpatientOutpatientoffsiteoffsite clinical research studies clinical research studies


AssistAssist in implementation in implementation

DevelopDevelop flow sheets for flow sheets for research protocolsresearch protocols


CollectCollect data and samples data and samples

ObtainObtain consents and other consents and other protocol requirementsprotocol requirements

Core LaboratoryCore Laboratory

Sample Collection and Sample Collection and ProcessingProcessing

ImmunoassaysImmunoassays

Gas ChromatographyGas Chromatography

Mass SpectrometryMass Spectrometry

Core LabCore Lab

Nutritional Assessments Nutritional Assessments in:in:

* * Resting Metabolic RatesResting Metabolic Rates* Body Composition * Body Composition * Dietary intake* Dietary intake

Core LaboratoryCore Laboratory--GeneticsGenetics

Services ProvidedServices ProvidedIsolation and storage of Isolation and storage of DNA DNA DNA sequence analysisDNA sequence analysis

Education, Recruitment Education, Recruitment and Community Outreachand Community Outreach

We are your community We are your community Health Care LiaisonsHealth Care Liaisons

Regions CoveredRegions Covered (before)(before)

New regions covered (today)New regions covered (today)

Recruitment ComponentRecruitment Component

Assists in the Assists in the recruitment of all recruitment of all identified protocol identified protocol populationspopulations

Educational ComponentEducational Component

Educates community Educates community about the importance of about the importance of participation in clinical participation in clinical research studiesresearch studies

Educational CoreEducational Core

CoursesCoursesBiostatistics, Biostatistics, Epidemiology, Intro to Epidemiology, Intro to clinical research clinical research

Web based courses Web based courses

GCRC Seminar SeriesGCRC Seminar Series

Educational ComponentEducational ComponentInIn--House House

K30 program partnershipK30 program partnership

Tailored for individuals already possessing an Tailored for individuals already possessing an MD or PhD MD or PhD Individuals wishing to pursue careers in Individuals wishing to pursue careers in academic teaching or clinical investigation and academic teaching or clinical investigation and research research

K30 programK30 program (Mission )(Mission )

To assist participants in gaining all of the To assist participants in gaining all of the necessary tools to be successful clinical necessary tools to be successful clinical investigators investigators Offering opportunities for handsOffering opportunities for hands--on on clinical research "from the bench to the clinical research "from the bench to the bedside" under the guidance of an bedside" under the guidance of an experienced mentorexperienced mentor

K30 programK30 program

Formal coursework includesFormal coursework includes: : Epidemiology Epidemiology BiostatisticsBiostatisticsExperimental Clinical TrialsExperimental Clinical TrialsLegal, Ethical and Regulatory Issues in Clinical Legal, Ethical and Regulatory Issues in Clinical

ResearchResearch

K30 programK30 program (continued)(continued)

Data Management Data Management Manuscript Scientific Publishing Manuscript Scientific Publishing Grant WritingGrant Writing

K30 programK30 program (continued)(continued)

After completion of this After completion of this 22--Year ProgramYear Program, , participants will meet the criteria as defined by participants will meet the criteria as defined by the NIH for submission of their own:the NIH for submission of their own:

K23 Mentored Clinical Research Scholar Award K23 Mentored Clinical Research Scholar Award R01 NIH Research Project Grant.R01 NIH Research Project Grant.

For more information about the K30 For more information about the K30 Program, please contact:Program, please contact:

Margie Lundgren, Program CoordinatorMargie Lundgren, Program Coordinator

Clinical Research Training ProgramClinical Research Training ProgramL2L2--142 Health Sciences Center142 Health Sciences CenterZIP 8221ZIP 8221Tel: 6Tel: 6--90049004Email: Email: marjoriemarjorie..lundgrenlundgren@@stonybrookstonybrook..edu edu

Community Outreach Community Outreach ComponentComponent

Works in partnershipWorks in partnershipwith community groups with community groups to develop greater to develop greater understanding of their understanding of their importance in health importance in health carecare

Community Outreach Community Outreach ComponentComponent

Serves as a community Serves as a community resource for education resource for education and health concerns.and health concerns.

Community Outreach and Community Outreach and Education ComponentEducation Component

* * Site toursSite tours

* * Lecture seriesLecture series

* * Web siteWeb site::1) Study development 1) Study development

opportunitiesopportunities

2) Study updates2) Study updates

Community Outreach and Community Outreach and Education ComponentEducation Component

* Research study* Research studyPromotionPromotion

* * Website:Website:Research help cornerResearch help corner“Ask Dr. Sepulveda”“Ask Dr. Sepulveda”

Anything needed for study protocol we Anything needed for study protocol we will work to see it become reality!will work to see it become reality!

GCRCGCRC

WeWeareare

herehereforfor

youyou

general clinical research center at stony brook

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