general clinical research center at stony brook
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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
Informatics and Data Informatics and Data Management CoreManagement Core
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
Informatics and Data Informatics and Data Management CoreManagement Core
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
Nursing CoreNursing Core
AssistAssist in implementation in implementation
DevelopDevelop flow sheets for flow sheets for research protocolsresearch protocols
Nursing CoreNursing Core
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
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