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.
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QIBA is still evolving its processes but this page and the links present current thoughts.  Much of this is adapted from DICOM and IHE processes.
 
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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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* [[QIBA Profile Template]]
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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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* [[Change Tracking and File Naming]]
 
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* [[Profile Editions]]
 
  
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==Committee Procedures==
  
 
* [[Committee Procedures]]
 
* [[Committee Procedures]]
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* [[Publication Process]]
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** [[Voting Privileges]]
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* [[Balloting Process|Balloting Process and 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]]
  
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==Profile Creation==
  
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* [[: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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:* [[Profile Editions]]
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* [[Review Process]]
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* [[Public Comment Process]]
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* [[Publication Process]]
  
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==QIBA Profiling Stages==
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===Process Steps===
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[[Media:QIBA Profile Stages ver 21FEB2013.doc|QIBA Profile Stage Descriptions]] ''21Feb2013''
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
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* Selection Stage
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====Getting to Stage 1: Public Comment====
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** [[Selection Process|Submit Proposals]]
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:* [[Selection Process|Submit Proposals]]
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** [[Selection Process|Evaluate and Approve 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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* Drafting Stage
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====Getting to Stage 2: Consensus====
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** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
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:* [[Public Comment Process|Collect & Collate Public Comments]]
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** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* Reach Consensus on resolution for all comments
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** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
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** [[Review Process|Approve & Publish Public Comment Draft]]
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:* You have reached Stage 2
  
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* Review Stage
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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** [[Public Comment Process|Collect and Resolve Public Comment]]
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:* Recruit Sites to Field Test the Profile
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** [[Review Process|Approve & Publish Reviewed Draft]]
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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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* Technical Confirmation Stage
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====Getting to Stage 4: Claim Confirmed====
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** [[Confirmation Process|Distribute for Technical Confirmation]]
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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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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
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** [[Review Process|Approve & Publish Technically Confirmed Profile]]
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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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* Clinical Confirmation Stage
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====Profile Maintenance====
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** [[Confirmation Process|Distribute for Clinical Confirmation]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
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** [[Review Process|Approve & Publish Clinically Confirmed Profile]]
 
  
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* Maintenance
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====Profile Retirement====
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** [[Maintenance Process|Accept and Resolve Change Proposals]]
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:* [[Retirement Process|Review for Retirement]]
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** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
 
  
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* Retirement
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==Groundwork Projects and Funding==
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** [[Retirement Process|Review for Retirement]]
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[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
  
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==Groundwork Projects and Funding==
 
 
* [[Groundwork Process]]
 
* [[Groundwork Process]]
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**[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
 
* Funding Submission Process
 
* Funding Submission Process
 
* Evaluation and Selection Process
 
* Evaluation and Selection Process
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* Publication of Results - discuss where, how, level of detail, embargo period (6 months from completion of project?)
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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 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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