Difference between revisions of "Process"

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==Overview==
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QIBA ''' ''industrializes'' biomarkers''' by selecting biomarkers ready for industrialization, investigating underlying sources of variance and practical impediments to their use, and drafting specification documents ("Profiles") to help vendors and healthcare providers overcome those impediments and sources of variance.
QIBA attempts to ''' ''industrialize'' biomarkers''' by selecting biomarkers ready for industrialization, investigating underlying sources of variance and other practical impediments to their use, and drafting specification documents ("Profiles") to help vendors and healthcare providers overcome those impediments and sources of variance.
 
  
The details of how those steps are carried out is described here.  The '''[[Process Coordinating Committee]]''' manages this content.
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The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content. Comments are welcome. [mailto:qiba@rsna.org Email QIBA]
  
 
==Committee Procedures==
 
==Committee Procedures==
  
 
* [[Committee Procedures]]
 
* [[Committee Procedures]]
** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
 
** [[Balloting Process]]
 
** [[Voting Process]]
 
 
** [[Voting Privileges]]
 
** [[Voting Privileges]]
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* [[Committee Organization]]
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** [[Committee Sunset Process]]
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* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
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* [[Media:QIBA Conflict of Interest (COI) Policy-2021.10.28.pdf|QIBA Conflict of Interest (COI) Policy]]
  
==Profiling Process==
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==Profile Creation==
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===Guidance===
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* '''[[How to Write a Profile]]'''
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:* [[QIBA Profile Template]]
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:* [[Claim Guidance]]
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:* [[Vetting Requirements]]
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:* [[Expressing Requirements]]
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:* [[Assessment Procedure Guidance]]
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:* [[Profile Editions]]
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* [[Review Process]]
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* [[Public Comment Process]]
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* [[Publication Process]]
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===Process Steps===
 
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
 
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
'''Selection'''
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====Getting to Stage 1: Public Comment====
 
:* [[Selection Process|Submit Proposals]]
 
:* [[Selection Process|Submit Proposals]]
 
:* [[Selection Process|Evaluate and Approve Proposals]]
 
:* [[Selection Process|Evaluate and Approve Proposals]]
 
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:* Start Drafting the Profile
'''Stage 1: Drafting and Public Comment Stage'''
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:** See '''[[How to Write a Profile]]''' including specific editing guidelines
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
 
:** See [[How to Write a Profile]]
 
 
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
 
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
:** See [[Work Product for Review]]
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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
:* You have completed Stage 1
 
  
'''Stage 2: Consensus Stage (Publicly Reviewed)'''
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====Getting to Stage 2: Consensus====
 
:* [[Public Comment Process|Collect & Collate Public Comments]]
 
:* [[Public Comment Process|Collect & Collate Public Comments]]
 
:* Reach Consensus on resolution for all comments
 
:* Reach Consensus on resolution for all comments
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
:* You have completed Stage 2
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:* You have reached Stage 2
 
 
'''Stage 3: Technical Confirmation Stage'''
 
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
 
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
 
:* You have completed Stage 3
 
  
'''Stage 4: Claim Confirmation Stage'''
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
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:* Recruit Sites to Field Test the Profile
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
:* You have completed Stage 4
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile
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:* You have reached Stage 3
  
'''Stage 5: Clinical Confirmation Stage'''
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====Getting to Stage 4: Claim Confirmed====
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
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:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
:* You have completed Stage 5
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:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
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:* You have reached Stage 4
  
'''Profile Maintenance'''
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====Profile Maintenance====
 
:* [[Maintenance Process|Accept and Resolve Change Proposals]]
 
:* [[Maintenance Process|Accept and Resolve Change Proposals]]
 
:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
 
:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
  
'''Profile Retirement'''
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====Profile Retirement====
 
:* [[Retirement Process|Review for Retirement]]
 
:* [[Retirement Process|Review for Retirement]]
  
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* [[Groundwork Process]]
 
* [[Groundwork Process]]
** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
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**[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
 
* Funding Submission Process
 
* Funding Submission Process
 
* Evaluation and Selection Process
 
* Evaluation and Selection Process
** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
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**[[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
 
* Publication of Results - discuss where, how, level of detail, embargo period (6 months from completion of project?), extension requests, completion=submission of report, actual posting/publication can be later
 
* Publication of Results - discuss where, how, level of detail, embargo period (6 months from completion of project?), extension requests, completion=submission of report, actual posting/publication can be later
  
 
==Conformance==
 
==Conformance==
 
* [[Profile Conformance]]
 
* [[Profile Conformance]]
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:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
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==See Also==
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* '''[[How To's]]''' for this Wiki
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* [[:Category:Templates|Wiki Page Templates]]
  
==See Also==
 
 
* [[Profile Editions]]
 
* [[Profile Editions]]
 
* [[Change Tracking and File Naming]]
 
* [[Change Tracking and File Naming]]
* [[:Category:Templates|Wiki Page Templates]]
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* [[Clinical Trial Planning]]
* '''[[How To's]]''' for this Wiki
 
* [[Public Comment Process]]
 
* [[Review Process]]
 
* [[Publication Process]]
 
  
 
* [[Orphan Documents]]
 
* [[Orphan Documents]]
 
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA
 
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA

Latest revision as of 19:21, 8 November 2022

QIBA industrializes biomarkers by selecting biomarkers ready for industrialization, investigating underlying sources of variance and practical impediments to their use, and drafting specification documents ("Profiles") to help vendors and healthcare providers overcome those impediments and sources of variance.

The details of how those steps are carried out is described here. The Process Coordinating Committee manages this content. Comments are welcome. Email QIBA

Committee Procedures

Profile Creation

Guidance

Process Steps

Understand QIBA Profile Stages & QIBA Concepts

Getting to Stage 1: Public Comment

Getting to Stage 2: Consensus

Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)

Getting to Stage 4: Claim Confirmed

  • 4a. Design Method to assess site performance (in terms of metrics in Profile Claims, e.g., wCV)
  • 4b. Recruit sites to follow the Profile and assess site performance per 4a
  • 4c. Analyze Site Performance Data and assess against Profile Claim
  • 4d. Review & Approve then Publish Claim Confirmed Profile
  • You have reached Stage 4

Profile Maintenance

Profile Retirement

Groundwork Projects and Funding

Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.

Conformance

See Also