Sources
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Sources Related activities to draw from / support: – CDER – CDRH pathways – QIBA testbeds – Open Image Archives ad hoc committee – Biochange – TCGA Radiology and other correlative in-silico studies – JANUS – SDTM – QIN – RVL – Legacy understanding of requirements from current version of tools Workflows (priority order): 1. Suite: 1. Create and manage reference data sets using clinical and synthetic data 2. Comparative evaluation vs. gold standards or otherwise accepted markers 3. Measure correlation of imaging biomarkers with clinical endpoints 4. Compliance tests / proficiency testing of supplier implementations 5. Formal registration of data with FDA for qualification (CDER) and approval or clearance (CDRH) 2. Support experimental groundwork for marker development 3. Support algorithm discovery and early development November, 2010 Informatics Services for Quantitative Imaging 1
description
Sources. Related activities to draw from / support: CDER – CDRH pathways QIBA testbeds Open Image Archives ad hoc committee Biochange TCGA Radiology and other correlative in-silico studies JANUS – SDTM QIN RVL Legacy understanding of requirements from current version of tools - PowerPoint PPT Presentation
Transcript of Sources
SourcesRelated activities to draw from / support:
– CDER – CDRH pathways– QIBA testbeds– Open Image Archives ad hoc committee – Biochange– TCGA Radiology and other correlative in-silico studies – JANUS – SDTM – QIN– RVL– Legacy understanding of requirements from current version of tools
Workflows (priority order):1. Suite:
1. Create and manage reference data sets using clinical and synthetic data2. Comparative evaluation vs. gold standards or otherwise accepted markers3. Measure correlation of imaging biomarkers with clinical endpoints 4. Compliance tests / proficiency testing of supplier implementations 5. Formal registration of data with FDA for qualification (CDER) and approval or clearance (CDRH)
2. Support experimental groundwork for marker development3. Support algorithm discovery and early development
November, 2010 Informatics Services for Quantitative Imaging 1
