NCRP / RSCP Joint Meeting

24 September 2015

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Welcome

Network of Clinical Research Professionals

+Research Support Community of Practice

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A Joint Meeting

First Reaction

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A Joint Meeting

Second Reaction

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NCRP

The Network of Clinical Research Professionals is an

organization supported by the ¡Alianza! program and

offers networking opportunities and activities to

enhance education, training and career development

for clinical research support staff.

• Every clinical department, center and institute

• Continuous learning

• Shared tips & techniques

• Face-to-face meetings

• Career development

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RSCP

The Research Support Community of Practice is a

dynamic group of analysts, managers, administrators,

and others who share a concern or a passion for

supporting MSOM investigators in funding biomedical

breakthroughs, and devote a portion of their time to

learning how to do it better as they interact regularly at

meetings and via electronic means.

• Every department, center and institute

• Continuous learning

• Sharing tips & techniques

• Face-to-face meetings

• Career development

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Touchpoints: Clinical Research Process

PI

SponsorGrant/

ContractVelos

Charges/ Invoice

Budget

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Clinical Translational

Research Network

Protocol Initiation

Protocol Support

Education and

Assessment

Operations and

Regulatory Support

Research Pharmacy

Hospital Liaisons

Participant Recruitment

A comprehensive and integrated group of

experts who will provide services for all

affiliated clinical research

Our Vision for Clinical Translational Research

all

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RIM

Interim Executive Dean for Research and Research

Education

Clinical Research Operations & Regulatory Support

Graduate & Postdoctoral Studies

Research Development & Support

RIM OpsData & Finance

Research Writing CenterUnder Construction

Clinical Translational Research Site

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CTRN

Clinical Translational Research Network

Recruitment

Medical Director, Clinical Research

AVP, Research Support Ops

Executive Dean

Research

Hospital Research Liaisons

Protocol Initiation Unit

Clin Research Ops & Reg Support

PI, CTSI

Research Pharmacy

Protocol Support Unit

Education and Assessment Unit

Participant Recruitment

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CRORS

Clinical Research Operations & Regulatory Support

• Regulatory support• Monitoring plans for existing and new IND studies • Risk-based monitoring for Investigator-Initiated IND/IDE studies• Training on research related topics

NCRP: All of the above! RSCP: Share space on Dominion Tower 10th floor

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NCRP: RSCP:

CTRS

NCRP: All of the above!RSCP: Rates and budgets

Clinical Translational Research Site (CRC)

• CRB 7, UMH 7 South, UMH 6 West• Professional, high quality and safe

• Nursing services• Laboratory services• Facilities, equipment, study coordination

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NCRP: RSCP:

RD & S

NCRP: Small portfolio, large clinical trial, unit needs coverage

RSCP: All of the above!

Research Development and Support

Recruitment• Big Science• Small Portfolio• Community of Practice• Emergency Backup

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NCRP:

RSCP:

RIM Ops

NCRP: Velos compliance, preparedness, core facilities RSCP: Data, internal awards, metrics

• Data management• Velos compliance• Critical equipment• Preparedness

• Internal awards• Core facilities• Metrics• Finance

RIM Research Support Operations

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NCRP:RSCP:

OGPS

NCRP: Probably not muchRSCP: Graduate Fellowship proposals, Training Grant data

Office of Graduate and Postdoctoral Studies

• PIBS Program• PhD in Biomedical Sciences

• Masters Programs• Postdoctoral Trainees

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NCRP: RSCP:

RWC

NCRP: Publications and proposalsRSCP: Proposals

Research Writing Center

• Assist faculty in presenting their science to publishers and sponsors• Writer• Editor• Graphic Designer

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NCRP: RSCP:

You have a question . . . .

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Scenario One

A sponsor asks you what rank your department is in the Federal Fiscal Year 2014 rankings. What’s MSOM NIH ranking?

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Scenario Two

A faculty member comes back from a donor luncheon. She says “This Foundation has a little bit of money to disperse before October 31. Can you pull something together?”

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Scenario Three

You need to know where the non-standard of care activities can be performed and how much you should budget.

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Scenario Four

A physician-scientist asks you to assist with his first clinical trial.

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Scenario Five

You need to get CMS approval for an IDE study.

CTRN

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Scenario Six

Your PI wants to propose a clinical trial that includes four MSOM departments.

RD&S

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RIM: A Small but Mighty Force

Working to facilitate quality clinical research at the MSOM

http://research.med.miami.edu/

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