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Research Concierge

Research Concierge . The research Concierge assists researchers by assessing research needs, guiding them through the research infrastructure, matching their needs with the expertise of faculty members, and facilitating access to CCTS services, resources and tools.

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Research Concierge

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  1. Research Concierge The research Concierge assists researchers by assessing research needs, guiding them through the research infrastructure, matching their needs with the expertise of faculty members, and facilitating access to CCTS services, resources and tools. Elodie Elayi, MSConcierge/Research Development DirectorPhone:(859) 323-7939elodie.elayi@uky.edu

  2. What’s a BERD? Biostatistics, Epidemiology, and Research Design

  3. How do I utilize the BERD? Submit a Request: Email catherine.starnes@uky.edu Pizza & Pilots: “How to Write Good Objectives” October 29, 2012 @ 12pm A series offered by the BERD and sponsored by the CCTS focused on study design. Workshops: Workshops are offered upon request. Pizza & Pilots is a regular series offered by the BERD and sponsored by the CCTS on the last Monday of each month.

  4. Biospecimens Core • Available now: • Partnership with Kentucky Women’s Health Registry • Blood, urine, fingernails from 102 Kentucky women • Samples are available on request (no new IRB required) • Biospecimens are linked to self-reported health data • Plans to extend collection program to Appalachia • Ken Campbell, PhD, Director • Peter Nelson, MD, PhD, Co-Director • Srinath Kamineni, MD, Co-Director • Brian Raisler, PhD, Biobanking Lead • Email: biospecimens@uky.edu

  5. Biospecimens Core • Biospecimen procurement – transformative UK-wide system • IRB currently pending • Opt-in consent at patient registration • Ability to bank samples (blood, tissue, etc.) not required for carethat would otherwise be discarded • Biospecimens linked to de-identified medical records • Phased roll out, expected to start Fall / Winter 2013 • Many projects will not require a new IRB • Email: biospecimens@uky.edu for more information

  6. Biomedical Informatics (BMI)Enterprise Data Trust Informatics Research Expertise Web-Based Software Tools Available Data for Research Use For additional information or to request a service, visit: http://www.ccts.uky.edu/BIC/ OR Contact Tamela.Harper@uky.edu

  7. BMI Consultations/Collaborations for Research • Data Mining • Database Design • Data Visualizations • Imaging Informatics • Natural Language Processing (NLP) • Social Networking Analysis • Gene Sequencing Analysis • REDCap • User friendly interface for survey or data collection form creation • Web based data entry • Audit trails for logging changes in data • Export data to common stats packages • User support and training is available • i2b2 • Quick aggregate counts to determine available patient populations • No IRB required to access the tool • User support and training is available

  8. UK HealthCare • Inpatient data • 2006-present • Deidentified data does not require an individual IRB • Markey Cancer Center • ~1800 consented patients for biospecimen samples tied to medical history • Serve as honest broker to facilitate UKHC medical history • Kentucky Cancer Registry • Serve as honest broker to facilitate UKHC medical history • KY Medicaid • State data • 2000-2012 • Requires UK and KY Cabinet IRB • Commercially Insured Population • National data, employed with dependents • 15 million lives • 2007-2009 • Deidentified data does not require an individual IRB • HealthCare Cost & Utilization Project (HCUP) • Nationwide Input Sample: inpatient data from a sample of 1000+ hospitals (1988 - 2009) • State Inpatient Database: discharge abstracts (2008-2012) • State ED Databases: data from ED visits that do not result in hospitalization (2008-2012) • Requires IRB • Social Security Death Master File • 1950-2013 • No IRB required

  9. Community EngagementDirector, Nancy Schoenberg, PhDCo-Director, Kevin Pearce, MD, MPHProgram Manager, Carol White, MPH Connecting lay, practice, and academic communities as partners in community-engaged research to address health needs in Appalachian Kentucky

  10. Community Engagement Services Facilitating community-oriented research collaborations Providing consultations to guide and facilitate community-oriented research Offering training for community-oriented research Providing funding for community seed grants Providing access to CCTS Community Engagement Study Coordinators and Clinical Liaisons in Hazard and Morehead to support research activities

  11. Appalachian Translational Research Network (ATRN)UK ATRN Director: Patrick Kitzman PhD, MSPT • The ATRN is dedicated to enhancing research collaborations and seeking new avenues to address the significant health challenges and health disparities in Appalachia. • Current ATRN members: University of Kentucky, The Ohio State University, Ohio University, West Virginia University, University of Cincinnati, Marshall University, and University of Pikeville.

  12. Request Community Engagement Services Contact Carol White, MPH, Program Manager crwhit3@email.uky.edu 859-218-0588

  13. CCTS Pilot Funding Program Mission: To offer opportunities and resources necessary to support innovative, early stage and collaborative research approaches in clinical and translational studies and to promote the development of new methodologies and tools relevant to the health challenges and disparities faced by the citizens of Kentucky, Appalachia and other rural populations. Tom Curry, PhD, Program Director Elodie Elayi, MS, Program Coordinator Judy Evans Pack, Budget Administration

  14. Categories Of Funding • Junior Investigator Award: $25,000 • High Impact and Innovative Award: $50,000 • Community Engagement Award: $25,000 • Drug Development Award: $50,000 • CCTS Partners (OSU, UC, MU, WVU) Collaborative Awards: $50,000 • CCTS Centers (BB, SB, MCC, SCoBIRC) Collaborative Awards: $50,000 • Community Engagement Mini Grant Awards: $2,500 • Novel Methodology Awards: $15,000 For Detailed Information: http://www.ccts.uky.edu/Investigators/pilotstudy.aspx or contact Elodie Elayi: elodie.elayi@uky.edu

  15. Clinical Service Core (CSC)Clinical Operations Facilities: 5N Inpatient Unit (15 beds/8 rooms) and hospital nursing staff 3N Outpatient Unit (6 exam rooms and a procedure room) Services: Study Coordination Generate source documents/Case Report Forms Assist/conduct clinical procedures (Vitals, medication administration, PK sampling, IV insertion, biopsies, EKG, telemetry, patient education, and /or surveys) Participant monitoring/Adverse event surveillance Specimen collection, process and shipping Travel offsite to collect specimens/research data

  16. CSC Grants/Fiscal Management • Budget development and negotiation • Complete internal forms • Ongoing grants management • Monitor for university and federal cost accounting standards • Subject billing auditing/compliance • Assist with budget/contract amendments

  17. CSC Participant Recruitment/Marketing Recruitment Advertising • Develop and design marketing plans for recruitment of participants • Newspaper ads, radio copy, internet ads written, cost negotiated, ads place • 6 Stationary wall mounts for flyers, with distribution metrics • Provide UK PR, IRB, and FDA compliance assistance • Attend community outreach event, your presence at our booth is welcome • Provide UK PR, IRB and FDA compliance assistance

  18. CSC Participant Recruitment/Marketing Clinical Research Studies & Social Media Web sites: • Clinical Research Opportunities Wildcat Database (CROWD) Be Part of the CROWD! UKClinicalresearch.com • UK Healthcare.uky.edu/patient/clinicalresearch.asp • ResearchMatch.org (Consortium Database) • CenterWatch.com & CISCRP.org • UKCCTS Facebook, _Twitter.com and YouTube.com/UKClinicalResearch

  19. CSC Biochemical Analysis Lab (BAL) • Methodology consultation and novel assay development • Performs assays not routinely available through the Hospital Clinical Laboratory, e.g., cytokines growth factors, hormones • Capabilities to run assays for the Luminex, Immulite, ELISA, chemiluminescence plate reader and endotoxin analysis • Networked with other laboratories greatly enhancing assay capability

  20. CSC Functional Assessment and Body Composition Core • Methodology and Analyses consultation • DXA • Bod Pod • Anthropometry • BIS • Resting and exercise blood pressure • 12 lead ECG • Treadmill and bicycle ergometry • Breadth by breath oxygen • Consumption • Basal metabolic rates • PFT

  21. Regulatory Support and Research Ethics • Assist with Regulatory process • Development and submission of IRB applications • Development of electronic tools and forms • FDA Investigational New Drug/Device applications • Registration on Clinicaltrials.gov • Quality Improvement program • Data Safety and Monitoring Board (DSMB) • FAQs for Community Investigators • Regional IRB Consortium • IRBShare Robert Means, Jr., MD, Director & Research Participant Advocate Ada Sue Selwitz, MA, Co-Director Marietta Barton-Baxter, CCRC, Administrative Director

  22. Medical Center Library http://libraries.uky.edu/MCL Susan Foster-Harper, CCTS Library Liaison

  23. Medical Center Library Questions about compliance? http://libguides.uky.edu/NIHPublicAccess

  24. Novel Clinical & Translational Methodologies (NCTM) • Encourage investigators to develop novel medical devices and diagnostics • Accelerate some projects toward commercialization • Train the next generation of the clinical and translational science researchers in commercialization pathways Greg Gerhardt, Anatomy and Neurobiology Greg.gerhardt@uky.edu Eric Grulke, Chemical and Materials Engineering Eric.grulke@uky.edu

  25. NCTM • Expanded services: consulting and product triage on new medical device and diagnostics concepts • Pilot awards: a grant program to help faculty-linked projects win SBIR/STTR funding • Educational programs: ‘Novel technology for dummies’ – a workshop for students and post-docs on converting their concepts to products and services

  26. Training, Education and Mentoring (TEAM) Victoria L. King, PhD Research & Leadership Development Director 323-1225 vicky.king@uky.edu Thomas H. Kelly, PhD Director 323-5206 thkelly@uky.edu

  27. TEAM Educational Programs • KL2 Career Development Program for 6 Junior Faculty • 75% release time, research support, mentoring, career development • 3 KL2 Scholars awarded NIH grants • Brandon Fornwalt, MD, PhD, Pediatric Cardiology • Brian Noehren, PT, PhD, Rehabilitation Sciences • Qing-Bai She, PhD, Markey Cancer Center • TL1 Institutional Training Program for Pre-doctoral Students • Stipend, tuition, health insurance for 4 pre-doctoral students • Professional Student Mentored Research Fellowship (PSMRF) • Introduction to Clinical Research Course/Workshop • 1-year mentored research ($3,000) for 25-30 professional students

  28. TEAM Credentialing and Career Development • Certificate and Degree Programs • Graduate Certificate in Clinical and Translational Science • Graduate Certificate in Clinical Research Skills • MS in Medical Sciences – Clinical & Translational Science Pathway • PhD in Clinical and Translational Science • Other Career Development Activities • One-on-one Coaching & Mentoring • K Club for KL2 Scholars, Pilot Awardees • CTS Seminar for TL1, Certificate, PSMRF, MD/PhD Students • Coordinator 101 & Clinical Research Updates for Clinical Researchers • Info: Victoria King, PhD • Research & Leadership Development Director • Contact: vicky.king@uky.edu; 859-323-1225

  29. 8th Annual CCTS Spring Conference: April 8, 2013 • 5 Conferences • CCTS Spring Conference • Community Faculty/PBRN Conference • Research Day: Dentistry, Neuroscience, • Public Health • 648 attendees; 251 oral/poster presentations • Keynote: Chris Austin, MD, Director, • National Center for Advancing Translational Science (NCATS) • 9th Annual CCTS Spring Conference: Thursday, March 27, 2014 • CCTS Spring Conference • ATRN Annual Meeting • Research Day: Dentistry, Health Sciences, Neuroscience, Nursing

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