Difference between revisions of "Education"
Jump to navigation
Jump to search
m (→FDA Guidance) |
|||
| (6 intermediate revisions by 2 users not shown) | |||
| Line 1: | Line 1: | ||
| + | [[Image:QIBA_WIKI_BLURB.jpg|600px]] | ||
==QIBA in the Literature Citations== | ==QIBA in the Literature Citations== | ||
| − | |||
| − | + | A list of QIBA generated and/or cited articles can be found [https://pubmed.ncbi.nlm.nih.gov/?term=%28%22quantitative+imaging+biomarker+alliance%22%5BText%5D+OR+%22quantitative+imaging+biomarkers+alliance%22%5BText%5D+OR+%22QIBA%22%5BText%5D%29&filter=years.2007-2024&sort=date '''<u>HERE</u>'''] via a PubMed search. | |
| − | |||
| − | |||
| − | |||
| − | == | + | ==U.S. Food and Drug Administration (FDA) Guidance== |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket | The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket | ||
Submissions Guidance for Industry and Food and Drug Administration Staff was released on June 16, 2022, and can be accessed at this link or via the PDF below: | Submissions Guidance for Industry and Food and Drug Administration Staff was released on June 16, 2022, and can be accessed at this link or via the PDF below: | ||
| Line 22: | Line 13: | ||
This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions. | This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions. | ||
| − | *[[Media:06 16 2022 FDA Guidance.pdf | Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket ]] (June 16, 2022) | + | *[[Media:06 16 2022 FDA Guidance.pdf| Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket]] (June 16, 2022) |
==QIBA Historical Initiative== | ==QIBA Historical Initiative== | ||
| Line 47: | Line 38: | ||
'''2016''' | '''2016''' | ||
| − | *[[Media: SPSI24.mp4|The Road Ahead: The Role of QIBA in Demonstrating the Value of Quantitative Imaging, Daniel Sullivan, MD]] - November 28, 2016 | + | *[[Media:SPSI24.mp4|The Road Ahead: The Role of QIBA in Demonstrating the Value of Quantitative Imaging, Daniel Sullivan, MD]] - November 28, 2016 |
| − | *[[Media: SPSI24a.mp4|An Overview of the Quantitative Imaging Biomarkers Alliance (QIBA), Edward Jackson, PhD]] - November 28, 2016 | + | *[[Media:SPSI24a.mp4|An Overview of the Quantitative Imaging Biomarkers Alliance (QIBA), Edward Jackson, PhD]] - November 28, 2016 |
| − | *[[Media: SPSI24b.mp4|Introduction to the QIBA Process and Methodology, Kevin O'Donnell, MASc]] - November 28, 2016 | + | *[[Media:SPSI24b.mp4|Introduction to the QIBA Process and Methodology, Kevin O'Donnell, MASc]] - November 28, 2016 |
| − | *[[Media: SPSI24c.mp4|QIBA Deliverables: Science and Process, Paul Kinahan, PhD]] - November 28, 2016 | + | *[[Media:SPSI24c.mp4|QIBA Deliverables: Science and Process, Paul Kinahan, PhD]] - November 28, 2016 |
| Line 60: | Line 51: | ||
'''2018''' | '''2018''' | ||
| − | *[[Media:Conformance Assessment Introduction.pdf | Conformance Assessment Introduction (Nancy Obuchowski, PhD)]] - November 28, 2018 | + | *[[Media:Conformance Assessment Introduction.pdf| Conformance Assessment Introduction (Nancy Obuchowski, PhD)]] - November 28, 2018 |
| − | *[[Media:Transitioning QIBs into Clinical Trials.pdf | Transitioning QIBs into Clinical Trials: Practical Implementation Requirements (Nancy Obuchowski, PhD)]] - November 28, 2018 | + | *[[Media:Transitioning QIBs into Clinical Trials.pdf| Transitioning QIBs into Clinical Trials: Practical Implementation Requirements (Nancy Obuchowski, PhD)]] - November 28, 2018 |
'''2017''' | '''2017''' | ||
| − | *[[Media:QDET demonstration 20170119.pdf | Round-5 Cross-modality Project: QDET Demonstration]] - January 19, 2017 | + | *[[Media:QDET demonstration 20170119.pdf| Round-5 Cross-modality Project: QDET Demonstration]] - January 19, 2017 |
'''2016''' | '''2016''' | ||
<font color=green>'''Google Chrome''' or '''Firefox''' browsers are recommended for viewing these PowerPoint presentations.</font> | <font color=green>'''Google Chrome''' or '''Firefox''' browsers are recommended for viewing these PowerPoint presentations.</font> | ||
| − | *[[Media: | + | *[[Media:QIBA Process and Metrology-2016.11.18v2-ODonnell.pptx| RSNA2016 QIBA Session - Part II - Process and Metrology]] - Nov 2016 |
| − | *[[Media:QIBA Intro-2016.07.22.2016.pdf | Introduction to the Quantitative Imaging Biomarkers Alliance {QIBA ®}]] - July 22, 2016 | + | *[[Media:QIBA Intro-2016.07.22.2016.pdf| Introduction to the Quantitative Imaging Biomarkers Alliance {QIBA ®}]] - July 22, 2016 |
| − | *[[Media: | + | *[[Media:QIBA Expectations for Japan Activities-2016.04.u.pptx|QIBA Expectations for Japan Activities]] - April 17, 2016 JRS Conference, Yokohama, Japan |
* [http://www2.rsna.org/re/QIBA_Annual_Meeting_2016 2016 QIBA Annual Meeting Presentations] - April 13-14, 2016 Alexandria, VA | * [http://www2.rsna.org/re/QIBA_Annual_Meeting_2016 2016 QIBA Annual Meeting Presentations] - April 13-14, 2016 Alexandria, VA | ||
| Line 82: | Line 73: | ||
'''2010''' | '''2010''' | ||
| − | *[[Media: | + | *[[Media:Why QIBA CT specifics.pdf|"Why QIBA?" - Specifics associated with CT device and software manufacturers.]] |
| − | *[[Media: | + | *[[Media:Why QIBA PET-CT specifics.pdf|"Why QIBA?" - Specifics associated with PET-CT device and software manufacturers.]] |
| − | *[[Media: | + | *[[Media:Why QIBA MR specifics.pdf|"Why QIBA?" - Specifics associated with MR device and software manufacturers.]] |
* [http://www2.rsna.org/re/QI_IB_Special_Interest_Session_RSNA_2010/Index.htm 2010 RSNA QI/IB Special Interest Session Presentations] - November 29, 2010 RSNA, Chicago, IL | * [http://www2.rsna.org/re/QI_IB_Special_Interest_Session_RSNA_2010/Index.htm 2010 RSNA QI/IB Special Interest Session Presentations] - November 29, 2010 RSNA, Chicago, IL | ||
Latest revision as of 22:33, 8 February 2024
QIBA in the Literature Citations
A list of QIBA generated and/or cited articles can be found HERE via a PubMed search.
U.S. Food and Drug Administration (FDA) Guidance
The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance for Industry and Food and Drug Administration Staff was released on June 16, 2022, and can be accessed at this link or via the PDF below:
This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions.
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket (June 16, 2022)
QIBA Historical Initiative
Cancer Moonshot & QIBA [1]
- RSNA/QIBA is very pleased to announce that two of the QIBA Profiles relevant to cancer patients have been referenced and supported by the Federal Cancer Moonshot Initiative (https://medium.com/cancer-moonshot) as ways to advance research and outcomes.
- The FDG-PET/CT and CT Volumetry Profiles have been submitted as the most advanced Profiles to-date. Our sincerest appreciation to all of the QIBA participants who helped us arrive at this important milestone.
Biomarker Status Update Posters
QIBA Posters from RSNA Annual Meetings Archive
QIBA Special Interest Sessions at the RSNA Scientific Assembly and Annual Meeting
2018
2016
- The Road Ahead: The Role of QIBA in Demonstrating the Value of Quantitative Imaging, Daniel Sullivan, MD - November 28, 2016
- An Overview of the Quantitative Imaging Biomarkers Alliance (QIBA), Edward Jackson, PhD - November 28, 2016
- Introduction to the QIBA Process and Methodology, Kevin O'Donnell, MASc - November 28, 2016
- QIBA Deliverables: Science and Process, Paul Kinahan, PhD - November 28, 2016
Presentations
2018
- Conformance Assessment Introduction (Nancy Obuchowski, PhD) - November 28, 2018
- Transitioning QIBs into Clinical Trials: Practical Implementation Requirements (Nancy Obuchowski, PhD) - November 28, 2018
2017
- Round-5 Cross-modality Project: QDET Demonstration - January 19, 2017
2016
Google Chrome or Firefox browsers are recommended for viewing these PowerPoint presentations.
- RSNA2016 QIBA Session - Part II - Process and Metrology - Nov 2016
- Introduction to the Quantitative Imaging Biomarkers Alliance {QIBA ®} - July 22, 2016
- QIBA Expectations for Japan Activities - April 17, 2016 JRS Conference, Yokohama, Japan
- 2016 QIBA Annual Meeting Presentations - April 13-14, 2016 Alexandria, VA
2015
- 2015 QIBA Annual Meeting Presentations - May 6-7, 2015 Alexandria, VA
2014
- 2014 QIBA Annual Meeting Presentations - May 21-22, 2014 Hyatt Regency Crystal City, Arlington, VA
2010
- "Why QIBA?" - Specifics associated with CT device and software manufacturers.
- "Why QIBA?" - Specifics associated with PET-CT device and software manufacturers.
- "Why QIBA?" - Specifics associated with MR device and software manufacturers.
- 2010 RSNA QI/IB Special Interest Session Presentations - November 29, 2010 RSNA, Chicago, IL
2009
- 2009 Imaging Biomarkers Roundtable - Oncology Section - March 16-17, 2009
Consider also organizing or tagging presentations by topic?