Difference between revisions of "Process"

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{{TOCright}}
 
{{TOCright}}
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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.
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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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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]
  
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==Procedures and Conventions==
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==Committee Procedures==
  
 
* [[Committee Procedures]]
 
* [[Committee Procedures]]
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** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
 
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** [[Balloting Process]]
 
 
** [[Voting Privileges]]
 
** [[Voting Privileges]]
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* [[Review Process]]
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* [[Publication Process]]
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* [[Public Comment Process]]
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* [[Committee Organization]]
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** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
  
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* [[Profile Conformance]]
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==Profile Creation Process==
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* [[Profile Editions]]
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
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* [[Change Tracking and File Naming]]
 
  
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* [[:Category:Templates|Wiki Page Templates]]
 
  
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==QIBA Profiling Process==
 
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[[QIBA Profile Stages]]
 
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'''Selection'''
 
 
:* [[Selection Process|Submit Proposals]]
 
:* [[Selection Process|Submit Proposals]]
 
:* [[Selection Process|Evaluate and Approve Proposals]]
 
:* [[Selection Process|Evaluate and Approve Proposals]]
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:** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
 
  
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'''Drafting and Public Comment Stage'''
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'''Getting to Stage 1: Public Comment'''
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:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* Start Drafting the Profile
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:** [[QIBA Profile Template]] and [[Claim Guidance]]
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:** See [[How to Write a Profile]]
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:** 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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:* [[Review Process|Review & Approve]] Public Comment Draft then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
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:** [[Work Product for Review]]
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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
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'''Consensus Stage (Publicly Reviewed)'''
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'''Getting to Stage 2: Consensus'''
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:* [[Public Comment Process|Collect & Collate Comments]]
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:* [[Public Comment Process|Collect & Collate Public Comments]]
 
:* Reach Consensus on resolution for all comments
 
:* Reach Consensus on resolution for all comments
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:* [[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
  
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'''Technical Confirmation Stage'''
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'''Getting to Stage 3: Technically Confirmed'''
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:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
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:** [[QIBA Protocol/Profile Implementation Feedback Process]]
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:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]]
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:* [[Review Process|Review & Approve]] Technically Confirmed Profile then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
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:* You have reached Stage 3
  
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'''Claim Confirmation Stage'''
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'''Getting to Stage 4: Claim Confirmed'''
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:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
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:* [[Claim Confirmation_Process#Planning|Plan & Coordinate Claim Confirmation]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Claim Confirmation_Process#Soliciting Feedback|Collect and Resolve Feedback]]
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:* [[Review Process|Review & Approve]] Claim Confirmed Profile then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
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:* You have reached Stage 4
  
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'''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]]
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:* [[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'''
 
'''Profile Maintenance'''
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** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
 
** [[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
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==Conformance==
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* [[Profile Conformance]]
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==See Also==
 
==See Also==
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* [[Profile Editions]]
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* [[Change Tracking and File Naming]]
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* [[:Category:Templates|Wiki Page Templates]]
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* '''[[How To's]]''' for this Wiki
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* [[Public Comment Process]]
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* [[Review Process]]
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* [[Publication Process]]
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* [[Clinical Trial Planning]]
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* [[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
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* [[Orphan Documents]]
 
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* [[How to Write a Profile]]
 
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* '''[[How To's]]''' for this Wiki
 

Revision as of 21:11, 15 October 2018

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 Process

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

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

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