Research Concierge Elodie Elayi, MS Concierge/Research Development Director Phone:(859) 323-7939...
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Transcript of Research Concierge Elodie Elayi, MS Concierge/Research Development Director Phone:(859) 323-7939...
Research Concierge
Elodie Elayi, MSConcierge/Research Development Director
Phone:(859) [email protected]
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.
What’s a BERD?Biostatistics, Epidemiology, and Research Design
We provide
¨ Consultations on study design for clinical trials, community-based participatory research, and population-based (epidemiologic) studies
¨ Quantitative data analysis¨ Protocol review
For
¨ Pilot studies¨ Grant submissions¨ Publications
ByRichard Kryscio, PhD, Director Mary Kay Rayens, PhD Heather Bush, PhD, Associate Director Emily Van Meter, PhDRichard Charnigo, PhD Catherine Starnes
Submit a Request:Email [email protected]
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.
How do I utilize the BERD?
Biospecimens CoreAvailable 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, DirectorPeter Nelson, MD, PhD, Co-DirectorSrinath Kamineni, MD, Co-Director Brian Raisler, PhD, Biobanking Lead
Email: [email protected]
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 care
that 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: [email protected] for more information
Biomedical Informatics (BMI)Enterprise Data Trust
Informatics Research ExpertiseWeb-Based Software Tools
Available Data for Research Use
For additional information or to request a service, visit: http://www.ccts.uky.edu/BIC/
ORContact [email protected]
• 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
• Data Mining• Database Design• Data Visualizations• Imaging Informatics
• Natural Language Processing (NLP)• Social Networking Analysis• Gene Sequencing Analysis
BMI Consultations/Collaborations for Research
• 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
Community EngagementDirector, Nancy Schoenberg, PhD
Co-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
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
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.
Request Community Engagement Services
Contact Carol White, MPH, Program Manager
859-218-0588
CCTS Pilot Funding Program
Tom Curry, PhD, Program DirectorElodie Elayi, MS, Program Coordinator
Judy Evans Pack, Budget Administration
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.
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
Categories Of Funding
For Detailed Information: http://www.ccts.uky.edu/Investigators/pilotstudy.aspx
orcontact Elodie Elayi: [email protected]
Clinical Service Core (CSC)Clinical OperationsFacilities:
• 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
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
CSC Participant Recruitment/MarketingRecruitment 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
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
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
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
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-DirectorMarietta Barton-Baxter, CCRC, Administrative Director
Medical Center Libraryhttp://libraries.uky.edu/MCL
Susan Foster-Harper, CCTS Library Liaison
Medical Center LibraryQuestions about compliance?
http://libguides.uky.edu/NIHPublicAccess
Novel Clinical & Translational Methodologies (NCTM)
Greg Gerhardt, Anatomy and [email protected]
Eric Grulke, Chemical and Materials [email protected]
• 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
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
Training, Education and Mentoring (TEAM)
Victoria L. King, PhDResearch & Leadership Development Director
Thomas H. Kelly, PhD Director
TEAM Educational ProgramsKL2 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
TEAM Credentialing and Career DevelopmentCertificate 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
Info: Victoria King, PhDResearch & Leadership Development Director
Contact: [email protected]; 859-323-1225
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
8th Annual CCTS Spring Conference: April 8, 2013 5 Conferences
CCTS Spring ConferenceCommunity Faculty/PBRN ConferenceResearch Day: Dentistry, Neuroscience,
Public Health648 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