Difference between revisions of "Process"

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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.
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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.
  
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]]
** [[Review Process]]
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* [[Committee Organization]]
** [[Publication Process]]
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** [[Committee Sunset Process]]
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* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure 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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* [[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===
 
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
 
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
'''Getting to Stage 0: Selected'''  
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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]]
 
'''Getting to Stage 1: Public Comment'''
 
 
:* Start Drafting the Profile
 
:* Start Drafting the Profile
:** See [[How to Write a Profile]]
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:** See '''[[How to Write a Profile]]''' including specific editing guidelines
 
:** 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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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
 
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
'''Getting to Stage 2: Consensus (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 reached Stage 2
 
:* You have reached Stage 2
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'''Getting to Stage 3: Technically Confirmed'''
 
'''Getting to Stage 3: Technically Confirmed'''
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:* Recruit Sites to Field Test the Profile
 
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
 
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
 
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
 
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
:* [[Technical Confirmation Process#Soliciting Feedback|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]] then [[Publication Process|Publish]] Technically Confirmed Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
 
:* You have reached Stage 3
 
:* You have reached Stage 3
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'''Getting to Stage 4: Claim Confirmed'''
 
'''Getting to Stage 4: Claim Confirmed'''
:* [[Claim Confirmation_Process#Planning|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)
:* [[Claim Confirmation_Process#Soliciting Feedback|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]] Claim Confirmed Profile
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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
 
:* You have reached Stage 4
 
:* You have reached Stage 4
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'''Getting to Stage 5: Clinically Confirmed'''
 
'''Getting to Stage 5: Clinically Confirmed'''
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
 
:* You have reached Stage 5
 
:* You have reached Stage 5
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'''Profile Maintenance'''
 
'''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]]
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'''Profile Retirement'''
 
'''Profile Retirement'''
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==See Also==
 
==See Also==
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* '''[[How To's]]''' for this Wiki
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* [[:Category:Templates|Wiki Page Templates]]
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* [[Profile Editions]]
 
* [[Profile Editions]]
 
* [[Change Tracking and File Naming]]
 
* [[Change Tracking and File Naming]]
* [[:Category:Templates|Wiki Page Templates]]
 
* '''[[How To's]]''' for this Wiki
 
* [[Public Comment Process]]
 
* [[Review Process]]
 
* [[Publication Process]]
 
 
* [[Clinical Trial Planning]]
 
* [[Clinical Trial Planning]]
  
 
* [[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 20:21, 30 September 2020

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: 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