university of rochester clinical and translational science institute clinical & translational...
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University of RochesterClinical and Translational Science Institute
Clinical& Translational Science Institute
The Research Navigator Program: A Full-Service
Research Help Desk
Thomas T. Fogg MS MPHExecutive Director for Operations
University of RochesterClinical and Translational Science Institute
February 22, 2011
Clinical & Translational Science Institute
Four Specific Aims of the UR-CTSI
1. Create an academic home for clinical and translational research at the University of Rochester.
2. Organize services to better support investigators and their projects.
3. Create or reorganize four Centers of Research Excellence across the translational research spectrum.
4. Offer a broad range of education and training opportunities in clinical and translational research.
Clinical & Translational Science Institute
Four Specific Aims of the UR-CTSI
1. Create an academic home for clinical and translational research at the University of Rochester.
2. Organize services to better support investigators and their projects.
3. Create or reorganize four Centers of Research Excellence across the translational research spectrum.
4. Offer a broad range of education and training opportunities in clinical and translational research.
Clinical & Translational Science Institute
The Research Navigator Program functions as the University research “help desk.”
Research Navigator Program
Clinical & Translational Science Institute
• Mission: link researchers to resources, tools and collaborators
• Mechanisms:– Web-hosted guidance– Personalized assistance
The Research Navigator Program functions as the University research “help desk.”
Research Navigator Program
Clinical & Translational Science Institute
Customized Action Plan (CAP)
• Online tool– Guides investigators– What you need to know to plan and operate a study
• CAP Report Required approvals Available services Links to forms and policies Where to go for help
• CAP Reports– stored online– can be exported as PDFs with live links
Clinical & Translational Science Institute
CAP: a tool for facilitated planning
CAP Demonstration
Clinical & Translational Science Institute
Requesting Assistance
Submit questions and general requests by [email protected]
Request consultation services and vouchers through the CTSI Online Consultation Services Tool
All requests receive responses within 48 hours of submission
Clinical & Translational Science Institute
Consultation Services
The Research Navigator Program facilitates access to a range of consultation services for personalized assistance.CTSI-supported servicesOther services at the institutionServices outside the institution
Clinical & Translational Science Institute
Consultation Services
• Includes– Identifying potentially useful services– Advice regarding likely benefit of in-person
consultation
• Follow-up– Not just a hand-off– Support initiation of consultation– Check back
Clinical & Translational Science Institute
Available Services
Biomedical InformaticsBiostatisticsClinical Research EthicsSupport for ClinicalTrials.govCommunity EngagementCost EffectivenessData management EpidemiologyIND/IDE support & other FDA compliance
Human Behavior AssessmentHuman Subject Recruitment & RetentionLaboratory AssaysMolecular Biology AnalyticsPhysical Exercise, Activity & Kinesiology (PEAK) LabRegulatory SupportSurvey design and conduct
Mix of CTSI-supported and fee-based services
List is expanding
Clinical & Translational Science Institute
CTSI Voucher System
• Some services have fees
• CTSI vouchers – Standard:
• Up to 10 hours of fee-based consultation services• Limit of one voucher for the lifetime of a project• Good for 90 days
– Jumbo• Up to 40 hours of service• Must be approved by CTSI Executive Committee
Clinical & Translational Science Institute
Voucher Eligibility
• URMC investigator
• Clinical or translational research
• Without grant support for a project
• Not available to support grant-writing
Clinical & Translational Science Institute
Online Consultation Request Tool
Consultation Tool Demo
Clinical & Translational Science Institute
StaffingEric Rubinstein JD MPH, Director, Regulatory Knowledge and Support
Joan Adamo PhD, Co-Director, RKS and Research Navigator
Shanti Sharma PhD, Research Navigator
Mark Plessinger PhD, Research Navigator
Nancy Needler RN, Research Subject Advocate
Lauren Farberman MBA, Administrator, Research Navigator Program
Clinical & Translational Science Institute
# of Program Contacts
0
2
4
6
8
10
12
14
16
18
Aug Sep Oct Nov Dec Jan
w/ voucherw/o voucher
Totals
34 w/ voucher
38 w/o voucher