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NCRP / RSCP Joint Meeting
24 September 2015
1
Welcome
Network of Clinical Research Professionals
+Research Support Community of Practice
2
A Joint Meeting
First Reaction
3
A Joint Meeting
Second Reaction
4
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
5
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
10
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
11
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
12
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
13
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
14
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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