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]
  
==Procedures and Conventions==
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==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]]
  
==QIBA Profiling Process==
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==Profile Creation==
[[QIBA Profile Stages]] & [[QIBA Concepts]]
 
  
'''Selection'''  
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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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* [[Review Process]]
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* [[Public Comment Process]]
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* [[Publication Process]]
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===Process Steps===
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
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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
'''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]]
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:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
:** [[QIBA Profile Template]] and [[Claim Guidance]]
 
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
:* [[Review Process|Review & Approve]] Public Comment Draft then [[Publication Process|Publish]]
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:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
:** [[Work Product for Review]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
'''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]] Consensus Profile then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
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:* You have reached Stage 2
  
'''Technical Confirmation Stage'''
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
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:* Recruit Sites to Field Test the Profile
:** [[QIBA Protocol/Profile Implementation Feedback Process]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
:* [[Review Process|Review & Approve]] Technically Confirmed Profile then [[Publication Process|Publish]]
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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
  
'''Claim Confirmation Stage'''
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====Getting to Stage 4: Claim Confirmed====
:* [[Confirmation Process|Plan & Coordinate Claim 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]] Claim Confirmed Profile then [[Publication Process|Publish]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
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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
  
'''Clinical Confirmation Stage'''
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====Getting to Stage 5: Clinically Confirmed====
 
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
 
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
:* [[Review Process|Review & Approve]] Clinically Confirmed Profile then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
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:* You have reached Stage 5
  
'''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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==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==
 
* [[How to Write a Profile]]
 
 
* [[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
 
 
 
  
 
* [[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 20:31, 19 July 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

Getting to Stage 5: Clinically Confirmed

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