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==
 
 
* [[Change Tracking and File Naming]]
 
* [[Profile Editions]]
 
* [[Profile Conformance]]
 
  
 
* [[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]]
  
* [[:Category:Templates|Wiki Page Templates]]
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==Profile Creation==
  
==QIBA Profiling Process==
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===Guidance===
[[QIBA Profile Stages]]
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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]]
  
* Selection
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===Process Steps===
** [[Selection Process|Submit Proposals]]
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
** [[Selection Process|Evaluate and Approve Proposals]]
 
*** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
 
  
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====Getting to Stage 1: Public Comment====
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:* [[Selection Process|Submit Proposals]]
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:* [[Selection Process|Evaluate and Approve Proposals]]
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:* Start Drafting the Profile
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:** See '''[[How to Write a Profile]]''' including specific editing guidelines
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:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
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:* [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
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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]]
  
* Drafting and Public Comment Stage
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====Getting to Stage 2: Consensus====
** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* [[Public Comment Process|Collect & Collate Public Comments]]
*** [[QIBA Profile Template]] and [[Claim Guidance]]
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:* Reach Consensus on resolution for all comments
** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
** [[Review Process|Approve & Publish Public Comment Draft]]
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:* You have reached Stage 2
  
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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:* Recruit Sites to Field Test the Profile
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
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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
  
* Consensus Stage (Publicly Reviewed)
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====Getting to Stage 4: Claim Confirmed====
** [[Public Comment Process|Collect & Collate Comments]]
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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)
*** [[Work Product for Review]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
** Reach Consensus on resolution for all comments
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
** [[Review Process|Review & Approve Consensus Profile]]
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:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
** [[Publication Process|Publish Consensus Profile]]
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:* You have reached Stage 4
  
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====Getting to Stage 5: Clinically Confirmed====
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:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
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:* You have reached Stage 5
  
* Technical Confirmation Stage
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====Profile Maintenance====
** [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
*** [[QIBA Protocol/Profile Implementation Feedback Process]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
** [[Review Process|Review & Approve Technically Confirmed Profile]]
 
** [[Publication Process|Publish Technically Confirmed Profile]]
 
  
 
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====Profile Retirement====
* Claim Confirmation Stage
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:* [[Retirement Process|Review for Retirement]]
** [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
 
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
** [[Review Process|Review & Approve Claim Confirmed Profile]]
 
** [[Publication Process|Publish Claim Confirmed Profile]]
 
 
 
 
 
* Clinical Confirmation Stage
 
** [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
 
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
** [[Review Process|Review & Approve Clinically Confirmed Profile]]
 
** [[Publication Process|Publish Clinically Confirmed Profile]]
 
 
 
 
 
* Maintenance
 
** [[Maintenance Process|Accept and Resolve Change Proposals]]
 
** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
 
 
 
 
 
* Retirement
 
** [[Retirement Process|Review for Retirement]]
 
  
 
==Groundwork Projects and Funding==
 
==Groundwork Projects and Funding==
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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