Difference between revisions of "Process"

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QIBA is still evolving its processes but the following pages present current thoughts.
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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.
  
Much of this is adapted from DICOM and IHE processes.
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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]
  
==Overview==
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==Committee Procedures==
* [[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
 
  
==Procedures and Conventions==
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* [[Committee Procedures]]
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** [[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 Profile Template]]
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==Profile Creation==
* [[Change Tracking and File Naming]]
 
* [[File Naming]]
 
  
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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]]
  
* [[Committee Procedures]]
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===Process Steps===
* [[Publication Process]]
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
* [[Balloting Process]]
 
  
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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]]
  
* [[:Category:Templates|Wiki Page Templates]]  
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====Getting to Stage 2: Consensus====
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:* [[Public Comment Process|Collect & Collate Public Comments]]
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:* Reach Consensus on resolution for all comments
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
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:* You have reached Stage 2
  
==QIBA Profiling Stages==
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
* Selection
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:* Recruit Sites to Field Test the Profile
** [[Selection Process|Submit Proposals]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
** [[Selection Process|Evaluate and Approve Proposals]]
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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
  
* Drafting
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====Getting to Stage 4: Claim Confirmed====
** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
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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)
** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
** [[Review Process|Approve & Publish Public Comment Draft]]
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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
  
* Review
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====Getting to Stage 5: Clinically Confirmed====
** [[Public Comment Process|Collect and Resolve Public Comment]]
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:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
** [[Review Process|Approve & Publish Reviewed Draft]]
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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
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====Profile Maintenance====
** [[Confirmation Process|Distribute for Technical Confirmation]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
** [[Review Process|Approve & Publish Technically Confirmed Draft]]
 
  
* Clinical Confirmation
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====Profile Retirement====
** [[Confirmation Process|Distribute for Clinical Confirmation]]
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:* [[Retirement Process|Review for Retirement]]
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
** [[Review Process|Approve & Publish Clinically Confirmed Draft]]
 
  
* Maintenance
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==Groundwork Projects and Funding==
** [[Maintenance Process|Accept and Resolve Change Proposals]]
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[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
 
  
* Retirement
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* [[Groundwork Process]]
** [[Retirement Process|Review for Retirement]]
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** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
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* Funding Submission Process
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* Evaluation and Selection Process
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** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
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* 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

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