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.
  
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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]
  
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==Overview==
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==Committee Procedures==
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* [[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
 
  
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==Procedures and Conventions==
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* [[Committee Procedures]]
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** [[Voting Privileges]]
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* [[QIBA Profile Template]]
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* [[Committee Organization]]
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* [[Change Tracking and File Naming]]
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** [[Committee Sunset Process]]
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* [[Profile Editions]]
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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]]
  
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==Profile Creation==
  
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* [[Committee Procedures]]
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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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:* [[Profile Editions]]
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* [[Review Process]]
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* [[Public Comment Process]]
 
* [[Publication Process]]
 
* [[Publication Process]]
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* [[Balloting Process|Balloting Process and Voting Privileges]]
 
  
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===Process Steps===
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
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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]]
  
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* [[: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
  
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==QIBA Profiling Stages==
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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[[Media:QIBA Profile Stages ver 21FEB2013.doc|QIBA Profile Stage Descriptions]] ''21Feb2013''
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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
  
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* Selection Stage
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====Getting to Stage 4: Claim Confirmed====
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** [[Selection Process|Submit Proposals]]
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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)
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** [[Selection Process|Evaluate and Approve Proposals]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
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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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* Drafting Stage
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====Profile Maintenance====
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** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
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** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
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** [[Groundwork Process|Initiate/Conduct Groundwork]]
 
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** [[Review Process|Approve & Publish Public Comment Draft]]
 
  
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* Review Stage
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====Profile Retirement====
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** [[Public Comment Process|Collect and Resolve Public Comment]]
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:* [[Retirement Process|Review for Retirement]]
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** [[Review Process|Approve & Publish Reviewed Draft]]
 
  
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* Technical Confirmation Stage
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==Groundwork Projects and Funding==
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** [[Confirmation Process|Distribute for Technical Confirmation]]
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[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
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** [[Review Process|Approve & Publish Technically Confirmed Profile]]
 
  
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* Clinical Confirmation Stage
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* [[Groundwork Process]]
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** [[Confirmation Process|Distribute for Clinical Confirmation]]
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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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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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* Funding Submission Process
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** [[Review Process|Approve & Publish Clinically Confirmed Profile]]
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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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* Maintenance
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==Conformance==
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** [[Maintenance Process|Accept and Resolve Change Proposals]]
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* [[Profile Conformance]]
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** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
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:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
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* Retirement
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==See Also==
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** [[Retirement Process|Review for Retirement]]
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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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==See Also==
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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

Revision as of 19:21, 8 November 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

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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