Holly Morris MSN RN CCRC CHRC Director of CTSI Research Services Agenda Overview of NIH CTSA program and CTSA Award About the UF CTSI CTSI Services and Service Providers CTSI Funding support ID: 1043821
Download Presentation The PPT/PDF document "Facilitating Research Introduction to th..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. Facilitating ResearchIntroduction to the UF Clinical Translation Science InstituteHolly Morris, MSN, RN, CCRC, CHRCDirector of CTSI Research Services
2. AgendaOverview of NIH CTSA program and CTSA AwardAbout the UF CTSICTSI Services and Service ProvidersCTSI Funding supportCTSI NewsletterQ&A
3. Clinical and Translational Science Award Consortium: Accelerating Discoveries Toward Better HealthFunded by the NIH National Center for Advancing Translational Sciences
4. About the UF CTSIFounded in 2008Directed by David Nelson, MD (PI)CTSI functions:Provides support for research and translation to practice Deliver research services and resourcesCultivate a strong translational workforceConnects people and ideas across UF’s 16 colleges, the state and CTSA consortium, including new partnership with FSU Translational Workforce Development
5. The National Center for Advancing Translational Sciences (NCATS) defines “translation” as:Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.
6. Navigating the Research ProcessDesign a studyConduct a studyData management and softwareFacilitiesRecruit participantsFunding supportResearch Personnel
7. No Cost ConsultationsProject reviewAssistance to identify possible needs Connect to service providers and other possible collaboratorsEvaluate available resourcesMake recommendationsAssist with navigationIdentify education programsProvide letters of support
8. Services to help you design a study.
9. Biostatistics, Epidemiology and Research Design (BERD)DESIGNConsult, collaborate, educate and promote innovation in tools and methods related to study design and biostatistical issues in CTSIStudy design – clinical trials, observational studies, cohort, chart review, qualitative, epidemiologicPower analysisData analysisData presentation and visualizationQualitative research collaborationsSurvey designCTSI Design Studio lunch seriesMethod development
10. UF Library ServicesDESIGNThe CTSI Library Liaisons serve as a resource for those conducting clinical research at UF.Melissa Rethlefsen, MSLS, AHIPAssociate Dean, George A. Smathers LibraryFackler Director, Health Science Center LibrariesTerry Kit Selfe, DC, PhD CCRP Translational Research LibrarianSystematic Review serviceLibGuides for clinical researchConsultations: information needs, literature searches, electronic and print resources, research related toolsInformation-related classesPresentations for department meetings and journal clubsCollaborate on publications and grants
11. We provide data management and software assistance.
12. MANAGE DATACTS-ITWe help researchers execute discovery, produce scholarly works, manage research activitiesSystems and OperationsGeneral IT design and consultingServer and database provisioning, support and managementApplication hosting and supportInformatics platform implementationInformatics Services Consulting and designResearch grant assistanceResearch needs analysis and proposal developmentIDR and other clinical data accessSoftware design and development
13. MANAGE DATAREDCapA secure, web-based well-developed tool/application that facilitates data capture and management.REDCap can support multicenter and/or multiple arm studies.You decide who has access to your project and what users can do and see inside your project (‘user rights’). A low to no-cost alternative to custom built systems. Two tiered pricing model-you build with some training, or REDCap team builds for you. Classes and on-site expert support: CTSI-REDCAP-SUPPORT-L@LISTS.UFL.EDU
14. MANAGE DATAREDCap featuresAutovalidation of dataAbility to create calculated fieldsAbility to upload filesA scheduling moduleThe ability to apply branching/skip logic to questionsLongitudinal data collections, including survey dataEasily manage a contact list of survey respondents or create a simple survey link for participants Ability to develop secure web-based surveysSeamless data export to common data analysis packages Logging/audit trailsUser rightsRecord locking Graphical data view and statsReport BuilderData quality moduleTraining Resources module
15. Services to help you conduct a study.
16. Clinical Research Center MoreFacilitiesPersonnelExperienced research nurses, research coordinators, research assistants, dietician, laboratory support, medical technologistOutpatient facility including 14 exam rooms2 procedure roomsExercise physiology areaMetabolic kitchenInpatient research supportInvestigational pharmacyEquipment - basal metabolic cart, PFT testing, treadmill, exercise bike, pain testing, ultrasound CONDUCT
17. Investigational Drug Service (IDS)CONDUCTConsult with experts on applying human-validated assessment measures of behavioral concomitants of disease or therapeutic interventions. Positive pressure US 797 compliant clean roomClass A1 biological safety cabinetInvestigational pharmacyProtocol consultationsReceipt, storage and dispensing of investigational product
18. Advanced Research ResourcesCONDUCTClinical research project support and services Partial or Full FTE PersonnelClinical Research NursesResearch CoordinatorsResearch AssistantsInternal Study MonitoringQuality Control
19. BiorepositoryCONDUCTProvide high-quality biospecimens; biospecimen processing services; and an extensively monitored storage facility.Biospecimen storage, via CO2-backed-up freezers and reliable around-the-clock virtual-monitoring systemsBiorepository library specimen retrieval for investigator studies (fresh, fresh-frozen, formalin-fixed, paraffin-embedded tissue, DNA, plasma, serum, buffy coat)Biospecimen processing (tissue, whole blood and cerebrospinal fluid)Nucleic acid extraction and quality-assessment services
20. Services to help you recruit participants.
21. Recruitment CenterRECRUITAssistance to develop your Recruitment Plan Feasibility, communication strategies, creating recruitment materials and evaluation of recruitment methods. Social media recruitmentHealthStreetIntegrated Data Repository & Consent2ShareCollege of Journalism & CommunicationsUF Health Studies listingResearchMatchCTSA consortium institutions addressing recruitment challenges.
22. Integrated Data Repository (IDR)RECRUITAccess clinical data for cohort identification, recruitment of study population and to answer research questions.Visit idr.ufhealth.org/i2b2 for more informationHIPAA-compliant, IRB-approved “Limited Data Set” i2b2 Queries to determine cohort counts and study feasibility Secured per UF Health policies, the IDR aggregates data from clinical and administrative systems, including Epic. Demographics Inpatient and outpatient clinical encounter characteristics DiagnosesProceduresSelect lab resultsSelect nursing assessmentsComorbidity measures Select perioperative anesthesia dataPersonalized medicine genotyping dataBiospecimen availability UF Consent2Share patient research consent
23. Integrated Data Repository (IDR)RECRUITWhat is an i2b2?Data exploration and cohort discovery toolQuery curated dataReturns a number for unique patients that meet query criteriaCan be used for data exploration, study feasibility The ACT Network can be used to also help investigators identify additional sites for a clinical trial
24. Integrated Data Repository (IDR)RECRUITNCATS ACT i2b2 - An NIH-funded projectA nationwide network of 34 + sites sharing aggregate patient counts from EHR data to enable Accrual of patients to Clinical Trials (ACT Network)Encourages collaboration among sites100+ million patients across 34 sites
25. OneFlorida Clinical Research ConsortiumRECRUITStatewide clinical research network and OneFlorida Data Trust databaseAims to unite researchers, clinicians, patients and stakeholdersCollaborate with other OneFlorida sites An example of services include identifying cohorts and conduct observational research using de-identified patient-level health data from partners Learn more at onefloridaconsortium.org
26. Integrated Data Repository (IDR)RECRUITi2b2 instances available at UF
27. HealthStreetRECRUITRecruit participants from the community, including underrepresented populations.HealthStreet aims to:Assess medical problems and health concerns from community residents themselvesLink people, based on their needs and concerns, to medical and social services and opportunities to participate in health research Engage in bidirectional, health-promoting communication with and for the community Increase the community’s trust in the research enterprise through meaningful collaboration
28. HealthStreetRECRUITDemographicsTotal Members (N=9,089)Female59.1%Average Age44.0 yearsEthnicity: Asian African-American Caucasian Other1.2%60.3%33.0%5.5%Latino/Hispanic6.1%12+ years education79.1%Saw healthcare provider in past 12 months81.4%Insurance Status: Private Medicaid/Medicare No Insurance27.6%32.9%39.5%Employed34.8%>11,000Total HealthStreet Members 26# of counties we are in96%Members interested in research51%Members navigated to research43%Members enrolled among navigated16Colleges/Instsreceiving navigation assistance169Investigators receiving navigation assistance23,000+Services provided, including blood pressure, HIV screenings, clothing closet and toiletry pantry, etc.17,000+Referrals given for medical and social services
29. HealthStreetRECRUITReach of HealthStreet
30. Services to help you navigate regulations.
31. Regulatory Knowledge and SupportNAVIGATEAim to help research teams navigate the UF research landscape and the regulatory and compliance environment Research process consultations, informed consent consultations, my IRB submissionsIND, IDE assistanceClinicalTrials.gov assistanceEthics consultsResearch Subject AdvocateDSMB assistance by charterSOP developmentGLP, GMP, GCP support
32. Workforce Developmentprograms
33. Workforce DevelopmentTWDTo train and sustain the next generation clinical and translational workforceKL2 Multidisciplinary programTL1 Predoctoral Training ProgramClinical Research Professionals training and educational programsMentor AcademyMasters, Certificate, ConcentrationsEducational Scholarship programBioscience industry workforce
34. More technologies and services offered by our core facilities.
35. Biobehavioral CoreCenter for Cellular ReprogrammingCenter for Safety, Simulation & Advanced Learning TechnologiesGenotyping CoreBroad expertise in the application of human-validated assessment measures of behavioral concomitants of disease or therapeutic interventions.Services and training for induced Pluripotent Stem Cell (iPSC) derivation and related reprogramming technologies.Clinician training through simulation in processes, drugs and devices in order to promote patient safety.Consultation and guidance in designing and performing genetics and pharmacogenetics studies, and targeted determination of genotypes on genomic DNA from biological samples.Additional Core Facilities
36. Human Imaging CoreSoutheast Center for Integrated MetabolomicsTranslational Drug Development CoreInfrastructure and support to facilitate research and educational activities using Magnetic Resonance Imaging (MRI) technology, with particular emphasis on translational MRI research in humans.Metabolomics services for clinical and basic science studies, including mass spectrometry, nuclear magnetic resonance and bioinformatics.Promising compounds need assistance moving from the lab toward clinical trials, which generate the in vivo data needed for continued federal funding and licensing. The TDD core provides services and expertise in bioanalytical drug metabolism and preclinical pharmacokinetics in order to help faculty bridge this gapAdditional Core Facilities
37. How are CTSI services paid for? CTSI Support No-cost consultations Voucher program CTSI Pilot Awards Department funds Grant budgetsContracts line items
38. CTSI Pilot ProgramsSupports the growth of interdisciplinary and investigator-initiated clinical and translational research across UF’s broad range of scientific disciplines. Types of pilot awards:CTSI Pilot Awards (formerly Traditional, and Patient-Oriented Clinical combined) Focused on translational research Specialized: Focuses on a specific core or concept (Metabolomics, Translational Communication Research, Pain, Informatics, Precision Health)Translational: Designed to impact clinical practice – the “Learning Health System”
39. CTSI Voucher ProgramCovers some CTSI Services Funding up to $1,000Initial consultations required Website request
40. Get CTSI news, funding announcements and event updates once a week.
41. Contact the CTSIwww.ctsi.ufl.edu 352.273.8700hlmorris@ufl.edu 352.294.5881
42. How can we help you? Questions?