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__NOTOC__
 
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This Wiki is for collaborative creation of QIBA materials and ongoing activities.
 
 
 
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=
 
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=
  
'''QIBA Mission: Improve the value and practicality of quantitative biomarkers by reducing variability across devices, patients and time.'''
+
'''QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.'''
 
 
 
 
QIBA is an initiative to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice by engaging researchers, healthcare professionals and industry .  This involves:
 
 
 
:* collaborating to identify needs, barriers, and solutions to develop and test consistent, reliable, valid, and achievable quantitative imaging results across imaging platforms, clinical sites, and time.
 
:* accelerating the development and adoption of hardware and software standards needed to achieve accurate and reproducible quantitative results from imaging methods.
 
 
 
 
 
QIBA develops Profile specifications and coordinates the necessary research and qualification groundwork.
 
:* [[What Are Profiles and Protocols?]]
 
:* [[Media:Profiling.ppt|How Does QIBA Derive Profiles?]]
 
 
 
==QIBA Biomarker and Coordinating Committee Rosters==
 
 
 
 
 
 
 
*[[Archive for previously known QIBA Modality Committees]]
 
 
 
==QIBA currently has ten active biomarker committees:==
 
 
 
* [[Perfusion, Diffusion and Flow-MRI Biomarker Ctte]] [[Media:QIBA PDF-MRI Roster.pdf|(Roster)]]
 
* [[fMRI Biomarker Ctte]]  [[Media:QIBA fMRI_Roster.pdf|(Roster)]]
 
* [[PDFF Biomarker Ctte (proposed)]]  [[Media:QIBA PDFF Roster.pdf| (Roster)]]
 
* [[MRE Biomarker Ctte]]  [[Media:QIBA MRE Roster.pdf| (Roster)]]
 
* [[PET Amyloid Biomarker Ctte]] [[Media:QIBA PET-Amyloid Roster.pdf|(Roster)]]
 
* [[FDG-PET Biomarker Ctte]]  [[Media:QIBA FDG PET Roster.pdf|(Roster)]]
 
* [[SPECT Biomarker Ctte]]  [[Media:QIBA SPECT Roster.pdf| (Roster)]]
 
* [[CT Volumetry Biomarker Ctte]]  [[Media:QIBA_CT_VOL_Roster.pdf|(Roster)]]
 
* [[Lung Density Biomarker Ctte]]  [[Media:QIBA CT-Lung Density Roster.pdf|(Roster)]]
 
* [[Ultrasound SWS Biomarker Ctte]]  [[Media:QIBAUSSWSRoster.pdf|(Roster)]]
 
* [[AIUM/QIBA Ultrasound Volume Blood Flow Biomarker Ctte]]  [[Media:x.pdf|(Roster)]]
 
 
 
==Related Efforts==
 
 
 
:*QIBA Newsletter: https://www.rsna.org/QIBA_Newsletter.aspx
 
 
Welcome to the ''QIBA Newsletter'', an e-newsletter dedicated to providing news and information from the Quantitative Imaging Biomarkers Alliance (QIBA), formed by RSNA in 2007 to unite researchers, healthcare professionals, and industry stakeholders in the advancement of quantitative imaging and the use of biomarkers in clinical trials and practice. The ''QIBA Newsletter'' offers articles, web links and tools, as well as updates from technical committees and information about how you can participate in QIBA activities.
 
 
 
:*[[Pharma Imaging Network for Therapeutics and Diagnostics (PINTAD)]]
 
 
 
QIBA also has one active Ad Hoc committee:
 
:*[[Committee on Open Image Archives]]
 
 
 
QIBA also has one collaboration sub-committee (task force) with the RSNA Radiology Informatics Committee:
 
:*[[QIBA/RIC ctte]]
 
 
 
QIBA is also collaborating with UPICT (Uniform Protocols for Imaging in Clinical Trials):
 
:*[[UPICT]]
 
 
 
==Trial Implementation Documents==
 
 
 
 
 
:*[[QIBA Protocol/Profile Implementation Feedback Process]]
 
 
 
==Public Comment Documents==
 
Documents published by QIBA for public comment can be found here:
 
:*[[Work Product for Review]]
 
 
 
==Documents==
 
 
 
*[[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
 
*[[Media:2-QIBA Committee Structure 1-12-15.pdf|QIBA Committee Structure]]
 
*[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
 
*[[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
 
*[[Media:5-Definitions for QIBA Protocol and Profile 15Jan2015.pdf|Definitions for QIBA Protocols and Profiles]]
 
 
 
==Claim Guidance and Profile Template Documents==
 
  
===<font color=green>Claim Guidance</font>===
+
[[Image:QIBA_WIKI_BLURB.jpg|600px]]
*[[Media:ClaimStatementGuidance 17NOV2015.pdf|QIBA Profile Claim Guidance]] ''November 2015''
 
*[[Media:Minimum Requirements Claim Testing-10-12-2014.pdf|Minimum Requirements Claim Testing]] ''October 2014''
 
*[[Media:ClaimTemplate10-18-12-1_Obuchowski.pdf|Explanation of changes to claim format]] ''July 2014''
 
  
===<font color=green>Profile Templates</font>===
 
  
*[[Media:Profile Template 05-NOV-2015.doc|QIBA Profile Template - Word Version (coming soon) (Process Committee Version)]] ''November 2015''  
+
:* [[Profiles|'''QIBA Profiles''']] standardize methods to create biomarkers that meet a claimed performance (accurate and reproducible).
*[[Media:Profile Template 05-NOV-2015.pdf|QIBA Profile Template - PDF Version for reference (Process Committee Version)]] ''November 2015''  
+
:* QIBA advances quantitative imaging in clinical trials and clinical practice.
 +
:* QIBA engages researchers, healthcare professionals and industry.
 +
:* '''[[QIBA Concepts]]''' & '''[[QIBA Overview]]''' & '''[[QIBA Collaborations]]'''
 +
:* '''[[Stakeholder Viewpoints|Stakeholder Benefits]]'''
  
<font color=red>Please note: Wiki conversion from .docx to .doc caused "alignment tabs" to become "traditional tabs."  PDF version of original layout posted for reference.</font>
 
  
*[[Media:QIBA Profile Stages ver 21FEB2013.doc|QIBA Profile Stage Descriptions]] ''21Feb2013''
+
The navigation box to the left provides access to:
 +
* '''[[Profiles]]''' - biomarker specifications published by QIBA
 +
* '''[[Committees]]''' - developing biomarker Profiles and related work
 +
* '''[[Process]]es''' - guidance used by all Committees for developing Profiles and other QIBA work
 +
* '''[[QIBA Profile Conformance | Conformance]]''' - Self Attestation and Certification Services
 +
* '''[[QIBA News]]''' - Recent biomarker committee accomplishments, volunteer news items to share
 +
* '''[[Education]]''' - Introduction to QIBA, ''QIBA Newsletter'' archive, QIBA posters and presentations, and citations
 +
* '''[[Catalog|Resource Catalog]]''' - used for QIBA groundwork
 +
* '''[[About QIBA|About QIBA]]''' - an at-a-glance introduction and QIBA YouTube Playlist
 +
* '''[[QIBA Acknowledgments]]''' - Thank you to our volunteers!
  
==QIBA Resources==
 
*[[Media:QIBA_Fact_Sheet_9-Oct-2015.pdf|QIBA Fact Sheet]] ''October 2015''
 
  
*[[Media:QIBA Org Chart 4-Sept-2015.pdf|QIBA Governance Structure]] ''September 2015''
 
  
*[[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
 
*[[Media:QIBA task force report 11-3-11.pdf|QIBA Task Force Report]] ''August 2011''
 
  
*[[Media:Guidance Standards for CTs.pdf|Guidance Standards for CTs]]
 
*[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance biomarker qualification Aug 2011]]
 
  
*[[Media:Guidance Standards for CTs.pdf|Guidance Standards for CTs]]
+
==<font color=blue>'''QIBA NEWS'''<font>==
*[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance biomarker qualification Aug 2011]]
 
  
*[[Media:Why_QIBA_CT_specifics.pdf|"Why QIBA?" - Specifics associated with CT device and software manufacturers.]]
+
'''
*[[Media:Why_QIBA_PET-CT_specifics.pdf|"Why QIBA?" - Specifics associated with PET-CT device and software manufacturers.]]
+
<font color="black">QIBA is Transitioning to QUIC!
*[[Media:Why_QIBA_MR_specifics.pdf|"Why QIBA?" - Specifics associated with MR device and software manufacturers.]]
 
  
==Posters==
+
'''
*[[QIBA posters from RSNA 2014 Annual Meeting]]
 
*[[QIBA posters from RSNA 2013 Annual Meeting]]
 
*[[QIBA posters from RSNA 2012 Annual Meeting]]
 
*[[QIBA posters and plenary session presentation from RSNA 2011 Annual Meeting]]
 
*[[QIBA and UPICT posters from RSNA 2010 Annual Meeting]]
 
*[[QIBA and UPICT posters from RSNA 2009 Annual Meeting]]
 
*[[Media:FREEMAN_FINAL_PROOF.pdf|QIBA posters from RSNA 2008 Annual Meeting]]
 
  
==Guidelines==
+
<font color="black">Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles.
 +
Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally.  The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations.
 +
Answers to the FAQ submitted by QIBA members are provided below.
  
*[http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule]
+
*[[Media:12.23.2023 QIBA_Accomplishments_TJH-2.PDF|QIBA Accomplishments Slides (Dr. Timothy J. Hall, PhD)]]
 +
*[[Media:09.07.2023 LINK to FAQ PDF document2.PDF|FAQ PDF document]]
 +
*[[Media:QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf |QUIC Profile Endorsement Criteria]]
 +
*[[Media:QIBA Summary Abridged Version 21Dec2023-B.pdf |QIBA Summary – Abridged Version 21Dec2023]]
  
*[[Media:EU.2009.08.04 Guideline on Clinical evaluation of diagnostic agents.pdf|EMEA Guideline on Clinical Evaluation of Diagnostic Agents (2009.08.04)]]
+
<font color="black">The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket
*[[Media:EU.2009.08.04 Appendix 1 to the guideline.pdf|EMEA Guideline - Appendix 1 (2009.08.04)]]
+
Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education.  
*[[Media:Oncology section.ppt|Oncology section from 2009 Imaging Biomarkers Roundtable]]
 
  
==Quantitative Imaging/Imaging Biomarkers and QIBA Meetings and Activities== 
 
  
*[[QIBA in the Literature Citations]]
+
<font color="black">QIBA Videos are now posted to RSNA's YouTube Channel!  https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.
 +
:[[Image:QIBA-YouTube-image.png|300px]]
  
*[[Media:Biomarker Roadmap orig 7-20-10-11-01-10 reformatted for QIBA website.pdf|Biomarker Roadmap (11-01-2010 version)]]
 
  
*QI/IB Special Interest Session-
 
Imaging Biomarkers for Clinical Care and Research
 
Monday, November 29, 2010
 
'''[http://www2.rsna.org/re/QI_IB_Special_Interest_Session_RSNA_2010/Index.htm Presentations]'''
 
  
*QIBA Annual Meeting Presentations
+
<font color="black">This wiki site is used primarily by the QIBA Committees.  For the more formal QIBA website, [http://www.rsna.org/qiba/ Click Here].
May 21-22, 2014
 
Hyatt Regency Crystal City, Arlington, VA
 
'''[http://www2.rsna.org/re/QIBA_Annual_Meeting_2014]'''
 
 
 
==2010-2012 NIBIB Contract Details==
 
 
 
 
 
*[[Media:HHSN268201000050C QIBA Final Report 29-March-2013.pdf|HHSN268201000050C QIBA (NIBIB) Final Report]] ''March 2013''
 
*[[Media:HHSN268201000050C QIBA 2nd Annual Report 26-OCT-2012.pdf|HHSN268201000050C QIBA (NIBIB) 2nd Annual Progress Report]] ''October 2012''
 
*[[Media:HHSN268201000050C QIBA 18mo Semi-Annual Report-FINAL-08MAR2012.pdf|HHSN268201000050C QIBA (NIBIB) SemiAnnual (18-month) Progress Report]] ''February 2012''
 
*[[Media:HHSN268201000050C QIBA Annual Report 30SEP2011.pdf|HHSN268201000050C QIBA (NIBIB) 1st Annual Progress Report]] ''September 2011''
 
*[[Media:HHSN268201000050C QIBA SemiAnnual Progress Report MARCH2011.pdf|HHSN268201000050C QIBA (NIBIB) SemiAnnual (6-month) Progress Report]] ''March 2011''
 
*[[Media:HHSN268201000050C QIBA Proposed Workplan 11-22-2010.pdf|HHSN268201000050C QIBA (NIBIB) Proposed Work Plan]] ''November 2010''
 
*[[Media:HHSN268201000050C QIBA Proposed Methology 10-11-2010.pdf|HHSN268201000050C QIBA (NIBIB) Proposed Methodology]] ''October 2010''
 
*[[Media:QIBA Round-1 Projects Overview.pdf|HHSN268201000050C QIBA (NIBIB) Round-1 Funded Projects Overview]]
 
*[[Media:NIBIB-QIBA -- Rnd-1 and 2 ProjectSummary--WIKI--Overview -- Updated 23Apr2012.xls|HHSN268201000050C QIBA (NIBIB) Round-1 and 2 Funded Project Overview]] ''23Apr2012''
 
 
 
==2013-2015 NIBIB Contract Details==
 
 
 
*[[Media:HHSN268201300071C QIBA SemiAnnualReport March2015-FINAL.pdf|HHSN268201300071C QIBA (NIBIB) SemiAnnual (18-Month) Progress Report]] ''March 2015''
 
*[[Media:HHSN268201300071C QIBA AnnualReport October2014 FINAL.pdf|HHSN268201300071C QIBA (NIBIB) 1st Annual Progress Report]] ''October 2014''
 
*[[Media:HHSN268201300071C QIBA SemiAnnualReport March2014 FINAL.pdf|HHSN268201300071C QIBA (NIBIB) SemiAnnual (6-Month) Progress Report]] ''March 2014''
 
*[[Media:HHSN268201300071C QIBA Proposed Workplan FINAL 11.29.2013.pdf|HHSN268201300071C QIBA (NIBIB) Proposed Work Plan]] ''November 2013''
 
*[[Media:HHSN268201300071C QIBA Proposed Methology 10-14-2013.pdf|HHSN268201300071C QIBA (NIBIB) Proposed Methodology]] ''October 2013''
 
 
 
 
 
==2015-2017 NIBIB Contract Details==
 
 
 
*[[Media:1-HHSN268201500021C QIBA Proposed Methodology FINAL October 2015.pdf|HHSN268201500021C QIBA (NIBIB) Proposed Methodology]] ''October 2015''
 
 
----
 
----
 
+
'''''Quantitative Imaging is a Work in Progress: read the [[Stakeholder Viewpoints|Stakeholder Benefits]]
NEW: '''[[How To's| "How To" help pages]]'''
 
 
 
*[[Media:Enabling E-alerts-20100504.pdf|Enabling E-alerts]]
 
 
 
*[[Media:Microsoft Word - WIKI PROTOCOL-v2.pdf|Posting Material]]
 
 
 
*[[Media:Wiki Help-History Overview2.pdf|History Search]]
 
 
 
'''''<This Wiki is a Work In Progress: read [[Help:Contents|Help]], create an [[Wiki Accounts|account]], contribute>'''''
 

Latest revision as of 22:14, 17 January 2024

Quantitative Imaging Biomarkers Alliance (QIBA)

QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.

QIBA WIKI BLURB.jpg



The navigation box to the left provides access to:

  • Profiles - biomarker specifications published by QIBA
  • Committees - developing biomarker Profiles and related work
  • Processes - guidance used by all Committees for developing Profiles and other QIBA work
  • Conformance - Self Attestation and Certification Services
  • QIBA News - Recent biomarker committee accomplishments, volunteer news items to share
  • Education - Introduction to QIBA, QIBA Newsletter archive, QIBA posters and presentations, and citations
  • Resource Catalog - used for QIBA groundwork
  • About QIBA - an at-a-glance introduction and QIBA YouTube Playlist
  • QIBA Acknowledgments - Thank you to our volunteers!



QIBA NEWS

QIBA is Transitioning to QUIC!

Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles. Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally. The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations. Answers to the FAQ submitted by QIBA members are provided below.

The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education.


QIBA Videos are now posted to RSNA's YouTube Channel! https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.

QIBA-YouTube-image.png


This wiki site is used primarily by the QIBA Committees. For the more formal QIBA website, Click Here.


Quantitative Imaging is a Work in Progress: read the Stakeholder Benefits