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University of Rochester Clinical and Translational Science Institute Clinical & Translational Science Institute The Research Navigator Program: A Full-Service Research Help Desk Thomas T. Fogg MS MPH Executive Director for Operations University of Rochester Clinical and Translational Science Institute February 22, 2011

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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

University of Rochester

University of Rochester Medical Center

Clinical and Translational Science Institute

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

Research Navigator Program

Clinical & Translational Science Institute

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 Question Structure

Clinical & Translational Science Institute

CAP Report Structure

Clinical & Translational Science Institute

CAP: a tool for facilitated planning

CAP Demonstration

Clinical & Translational Science Institute

Research Navigator Program

Clinical & Translational Science Institute

Research Navigator Program

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

Research Navigator Program

Clinical & Translational Science Institute

Research Navigator Program

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

QuickTime™ and a decompressor

are needed to see this picture.

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

Clinical & Translational Science Institute

By Service Type

Note - some encounters were for multiple services

Disciplinew/

Voucherw/o

VoucherBiostats 28 12CER 3Data Management 1Epidemiology 1General Navigation 20Informatics 2 3Lab Support 3PEAK 3Regulatory 8Survey Support 1 1