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New QIBA Biomarker Committee Application
Please describe how your biomarker will meet each of the five criteria below
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Your Name:
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Transformational
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Addresses a significant medical biomarker need with a likely considerable impact on public health, and addresses a critical gap in the biomarkers qualification/validation process.
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Translational
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Will likely result in significant improvement in the development, approval, or delivery of care to patients.
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Feasible
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An idea or program whose end goals can likely be achieved in a specific timeframe and that has a reasonable prospect of producing the expected outcomes; ideal programs are those which could result in regulatory qualification of a biomarker in three years.
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Practical
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Leverages preexisting resources (e.g., intellectual capital, personnel, facilities, specimens, reagents, data) wherever possible; warrants access to RSNA resources and support.
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Collaborative
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Would uniquely benefit from the multi-stakeholder composition and approach of QIBA and could be feasibly executed under its policies e.g. resulting in extension or adoption in product development among hardware, software, or imaging agents. The biomarker has the support of the stakeholder community with the organizational impetus to sustain continued efforts.
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Biomarker Use-case Specifications:
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(Please select all uses-cases for this quantitative biomarker; multiple use-cases may apply):
Clinical Use – Academic Site
Clinical Use – Community Site/Private Practice
Clinical Trial Use – iCRO/Pharma
Clinical Trial Use – Imaging Site(s)
Vendor Use – Software (e.g., reconstruction SW, image analysis tools, etc.)
Vendor Use – Hardware (e.g., scanners, workstations, etc.)
Society Collaboration (e.g., EARL pilot study, SNMMI, etc.)
Accreditation Organization Collaboration (e.g., RadSite)
Other:
Required
Additional Support for Biomarker Consideration:
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(Please select all that apply):
Biomarker is FDA approved
Biomarker is being assessed by FDA
CPT code is available for reimbursement
CPT code is being considered by CMS
Federal or private funding has been received for groundwork study
Federal or private funding has been applied for regarding groundwork study
Other:
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