Difference between revisions of "Process"

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__NOTOC__
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[[Image:QIBA_WIKI_BLURB.jpg|600px]]
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QIBA is still evolving its processes but the following pages present current thoughts.
 
  
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Much of this is adapted from DICOM and IHE processes.
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{{TOCright}}
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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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==Overview==
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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.  
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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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* [[QIBA Profile Template]]
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* [[Committee Procedures]]
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* [[Change Tracking and File Naming]]
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** [[Voting Privileges]]
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* [[Profile Editions]]
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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]]
  
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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]]
 
  
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===Process Steps===
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
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* [[:Category:Templates|Wiki Page Templates]]
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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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==QIBA Profiling Stages==
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====Getting to Stage 2: Consensus====
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[[Media:QIBA Profile Stages ver 21FEB2013.doc|QIBA Profile Stage Descriptions]] ''21Feb2013''
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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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* Selection Stage
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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** [[Selection Process|Submit Proposals]]
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:* Recruit Sites to Field Test the Profile
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** [[Selection Process|Evaluate and Approve Proposals]]
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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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* Drafting Stage
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====Getting to Stage 4: Claim Confirmed====
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** [[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)
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** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
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** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
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** [[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
  
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* Review Stage
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====Profile Maintenance====
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** [[Public Comment Process|Collect and Resolve Public Comment]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
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** [[Review Process|Approve & Publish Reviewed Draft]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
  
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* Technical Confirmation Stage
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====Profile Retirement====
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** [[Confirmation Process|Distribute for Technical Confirmation]]
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:* [[Retirement Process|Review for Retirement]]
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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 Projects and Funding==
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** [[Confirmation Process|Distribute for Clinical 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 Clinically Confirmed Profile]]
 
  
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* Maintenance
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* [[Groundwork Process]]
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** [[Maintenance Process|Accept and Resolve Change Proposals]]
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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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** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
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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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* Retirement
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==Conformance==
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** [[Retirement Process|Review for Retirement]]
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* [[Profile Conformance]]
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:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
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==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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==See Also==
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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 19:32, 19 January 2024

QIBA WIKI BLURB.jpg

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.

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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