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 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]]
  
* [[Profile Conformance]]
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==Profile Creation==
* [[Profile Editions]]
 
* [[Change Tracking and File Naming]]
 
  
* [[:Category:Templates|Wiki Page Templates]]
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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]]
  
==QIBA Profiling Process==
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===Process Steps===
[[QIBA Profile Stages]]
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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]]
:** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
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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]]
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:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
'''Consensus Stage (Publicly Reviewed)'''
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
:* [[Public Comment Process|Collect & Collate Comments]]
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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
:** [[Work Product for Review]]
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====Getting to Stage 2: Consensus====
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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
:* [[Review Process|Review & Approve Consensus Profile]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
:* [[Publication Process|Publish Consensus Profile]]
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:* You have reached Stage 2
'''Technical Confirmation Stage'''
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:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
:** [[QIBA Protocol/Profile Implementation Feedback Process]]
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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 Technically Confirmed Profile]]
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
:* [[Publication Process|Publish Technically Confirmed Profile]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile
'''Claim Confirmation Stage'''
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:* You have reached Stage 3
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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====Getting to Stage 4: Claim Confirmed====
:* [[Review Process|Review & Approve Claim Confirmed Profile]]
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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)
:* [[Publication Process|Publish Claim Confirmed Profile]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
'''Clinical Confirmation Stage'''
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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
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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]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
:* [[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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** [[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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:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
 
==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]]
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* [[Change Tracking and File Naming]]
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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
* [[Orphan Documents]]
 
* [[How to Write a Profile]]
 

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