You can ensure our resources are
available for all future research.
CitE!
Cite grant number UL1TR000117
for the NIH CTSA at UK
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, MS
Concierge/Research Development Director
Phone:(859) 323-7939
elodie.elayi@uky.edu
ACCELERATING DISCOVERIES TOWARD BETTER HEALTH
What’s a BERD?
Biostatistics, Epidemiology, and Research Design
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We provide
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Consultations on study design for clinical trials, community-based
participatory research, and population-based (epidemiologic) studies
Quantitative data analysis
Protocol review
Pilot studies
Grant submissions
Publications
Richard Kryscio, PhD, Director
Heather Bush, PhD, Associate Director
Richard Charnigo, PhD
Mary Kay Rayens, PhD
Emily Van Meter, PhD
Catherine Starnes
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
Pizza & Pilots is a regular
series offered by the BERD
and sponsored by the
CCTS on the last Monday
of each month.
A series offered by the BERD and sponsored by the CCTS
focused on study design.
Workshops:
Workshops are offered upon request.
Biospecimens Core
Available now:
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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
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: biospecimens@uky.edu for more information
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
BMI Consultations/Collaborations for Research
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• Natural Language Processing (NLP)
• Social Networking Analysis
• Gene Sequencing Analysis
Data Mining
Database Design
Data Visualizations
Imaging Informatics
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
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i2b2
– Quick aggregate counts to
determine available patient
populations
– No IRB required to access the tool
– User support and training is
available
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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
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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 Engagement
Director, Nancy Schoenberg, PhD
Co-Director, Kevin Pearce, MD, MPH
Program 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
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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
crwhit3@email.uky.edu
859-218-0588
You can ensure our resources are
available for all future research.
CitE!
Cite grant number UL1TR000117
for the NIH CTSA at UK
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
ACCELERATING DISCOVERIES TOWARD BETTER HEALTH
You can ensure our resources are
available for all future research.
CitE!
Cite grant number UL1TR000117
for the NIH CTSA at UK
Categories Of Funding
 Junior Investigator Award: $25,000
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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
ACCELERATING DISCOVERIES TOWARD BETTER HEALTH
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
CSC Grants/Fiscal Management
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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/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
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
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12 lead ECG
Treadmill and bicycle ergometry
Breadth by breath oxygen
Consumption
Basal metabolic rates
PFT
Regulatory Support and Research Ethics
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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
Medical Center Library
http://libraries.uky.edu/MCL
Susan Foster-Harper, CCTS Library Liaison
Medical Center Library
Questions about compliance?
http://libguides.uky.edu/NIHPublicAccess
Novel Clinical & Translational
Methodologies (NCTM)
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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
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)
Thomas H. Kelly, PhD
Director
323-5206
thkelly@uky.edu
Victoria L. King, PhD
Research & Leadership
Development Director
323-1225
vicky.king@uky.edu
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
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:
Contact:
Victoria King, PhD
Research & Leadership Development Director
vicky.king@uky.edu; 859-323-1225
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