research concierge

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Research Concierge Elodie Elayi, MS Concierge/Research Development Director Phone:(859) 323-7939 [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.

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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. - PowerPoint PPT Presentation

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Page 1: Research Concierge

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.

Page 2: Research Concierge

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

Page 3: Research Concierge

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?

Page 4: Research Concierge

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]

Page 5: Research Concierge

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

Page 6: Research Concierge

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]

Page 7: Research Concierge

• 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

Page 8: Research Concierge

• 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

Page 9: Research Concierge

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

Page 10: Research Concierge

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

Page 11: Research Concierge

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.

Page 12: Research Concierge

Request Community Engagement Services

Contact Carol White, MPH, Program Manager

[email protected]

859-218-0588

Page 13: Research Concierge

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.

Page 14: Research Concierge

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]

Page 15: Research Concierge

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

Page 16: Research Concierge

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

Page 17: Research Concierge

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

Page 18: Research Concierge

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

Page 19: Research Concierge

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

Page 20: Research Concierge

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

Page 21: Research Concierge

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 AdvocateAda Sue Selwitz, MA, Co-DirectorMarietta Barton-Baxter, CCRC, Administrative Director

Page 22: Research Concierge

Medical Center Libraryhttp://libraries.uky.edu/MCL

Susan Foster-Harper, CCTS Library Liaison

Page 24: Research Concierge

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

Page 25: Research Concierge

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

Page 26: Research Concierge

Training, Education and Mentoring (TEAM)

Victoria L. King, PhDResearch & Leadership Development

Director323-1225

[email protected]

Thomas H. Kelly, PhD Director323-5206

[email protected]

Page 27: Research Concierge

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 CardiologyBrian 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 studentsProfessional Student Mentored Research Fellowship (PSMRF) Introduction to Clinical Research Course/Workshop 1-year mentored research ($3,000) for 25-30 professional students

Page 28: Research Concierge

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

Page 29: Research Concierge

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